The fixed-duration treatment of venetoclax (Venclexta) plus obinutuzumab (Gazyva) continued to deliver long-term survival benefit for unfit patients with chronic lymphocytic leukemia (CLL) with coexisting conditions, according to updated efficacy and safety data from the ongoing phase 3 CLL14 trial (NCT02242942) presented during the 2022 EHA Congress.

At a median follow-up of 65.4 months, the median progression-free survival (PFS) for patients treated with venetoclax plus obinutuzumab was not reached (NR) compared with 36.4 months among patients treated with chlorambucil (Leukeran) plus obinutuzumab (HR, 0.35; 95% CI, 0.26-0.46; 

 < .0001). The 5-year PFS rates were 62.6% and 27.0%, respectively. Most patients treated with fixed-duration venetoclax plus obinutuzumab (63%) remain without a PFS event 4 years post treatment.

“What is important for us in these longer follow-ups is to really understand what happens with the disease dynamics and what happens with the patients when they get off treatment,” Othman Al-Sawaf, MD, a physician at the University Hospital of Cologne in Germany said in a presentation of the findings.

PFS benefits with venetoclax plus obinutuzumab were also observed across subgroups. The median PFS for patients without a 

 deletion or mutation was NR in the investigational arm compared with 38.9 months in the control arm. Patients with a 

 deletion or mutation experienced a median PFS of 49.0 months and 19.8 months, respectively.

 status the median PFS was NR in the investigational arm compared with 59.9 months in the control arm. The median PFS for patients with unmutated IGHV was 64.2 months and 26.9 months, respectively.

The CLL14 study enrolled patients with previously untreated CLL and coexisting medical conditions deemed unfit, who were randomly assigned 1:1 to receive either venetoclax plus obinutuzumab (n = 216) or chlorambucil plus obinutuzumab (n = 216). To be eligible for the trial, patients needed to have a total cumulative illness rating scale (CIRS) score greater than 6 and/or a creatine clearance of less than 70 mL/min.

Patients in the venetoclax arm were treated with 12 cycles of venetoclax administered in a ramp-up dosing schedule with 6 cycles of obinutuzumab. In the control arm, patients received 12 cycles of chlorambucil with 6 cycles of obinutuzumab.

The primary end point was PFS. Key secondary end points included response, minimal residual disease (MRD), and overall survival (OS).

Baseline patient characteristics were well balanced between the 2 arms; the median age was 72 years and 71 years in the venetoclax plus obinutuzumab and chlorambucil plus obinutuzumab arms, respectively. The median total CIRS score were 9 (range, 0-23) and 8 (range, 1-28), respectively. The median estimated creatine clearance was 65.2 mL/min and 67.4 mL/min, respectively.

Patients in the investigational arm had low (14%), intermediate (64%), and high (22%) tumor lysis syndrome (TLS) risk. Patients also had Binet stage A (21%), B (35%), and C (44%) disease. Comparatively, patients in the control arm mostly had an intermediate TLS risk (68%) and Binet stage C disease (43%).

Most patients in both the investigational and control arms had unmutated 

 (61% vs 59%). Twelve percent of patients in both arms had deleted and/or mutated 

. Common cytogenic subgroups included deletion in 11q (17% vs 18%), trisomy in 12 (17% vs 19%), no abnormalities (24% vs 20%), and deletion in 13q alone (34% vs 36%).

Additional findings from the trial showed that the median time to next treatment (TTNT) was NR in the venetoclax arm compared with 52.9 months in the control arm. The 5-year TNNT rates were 72.09% and 42.84%, respectively (HR 0.42; 95% CI, 0.31-0.57; 

Thirty-one patients in the venetoclax arm progressed to a second line of treatment compared with 94 patients in the chlorambucil plus obinutuzumab arm. Most of these patients in both arms subsequently received a Bruton tyrosine kinase (BTK) inhibitor as their second line therapy (58.1% vs 54.3%). PI3K inhibitors and CD20 antibodies were used in 1 patient each, both in the chlorambucil plus obinutuzumab arm. Chemotherapy or chemoimmunotherapy were used as a second line treatment in less than a third of patients in both arms (25.8% vs 30.9%).

Notably, the median OS was NR in either arm. The 5-year OS rates were 81.9% and 77.0% in the investigational and control arms, respectively (HR 0.72; 95% CI, 0.48-1.09; 

Additionally, a longitudinal MRD assessment found that 4 years after treatment with venetoclax plus obinutuzumab 18.1% of patients had sustained MRD of less than 10-4. In the other arm, 1.9% of patients treated with chlorambucil plus obinutuzumab experienced sustained MRD of less than 10-4 4 years after therapy.

The depth of remission beyond 10-4 correlates with long-term PFS, which indicates the value of ultra-sensitive MRD assessments, Al-Sawaf noted. Patients treated with venetoclax plus obinutuzumab with MRD of at least 10-4 experienced a shorter OS compared with those with MRD less than 10-4.

In terms of safety, the most common adverse events (AEs) grade 3 or higher that occurred with venetoclax plus obinutuzumab included neutropenia (51.9%), thrombocytopenia (14.2%), anemia (7.5%), and febrile neutropenia (4.2%). After treatment, common grade 3 or greater AEs included neutropenia (4%), pneumonia (3.0%), and anemia (2%).

In the chlorambucil plus obinutuzumab arm, the most common grade 3 or higher AEs reported during treatment included neutropenia (47.2%), thrombocytopenia (15%), and infusion-related reactions (9.8%). After treatment, common grade 3 or higher AEs included neutropenia (1.9%), pneumonia (1.4%), and anemia (0.5%).

Secondary primary malignancy (SPM) events occurred in 55 patients and 44 patients in the investigational and control arms, respectively. Patients had at least 1 SPM at a rate of 20.8% and 15.0%, respectively. Common SPMs included non-melanoma skin cancer (9.0% vs 8.4%), solid organ tumors (7.1% vs 4.7%), and melanoma (3.8% vs 1.4%). Investigators noted that there was no statistical difference in the cumulative incidence of SPMs between the 2 arms.

“So far, there were no new safety signals [with venetoclax plus obinutuzumab],” Al-Sawaf concluded. “Secondary malignancies remain statistically not significant between the arms, but [we will] continue to follow-up on safety and survival in this study.”

Al-Sawaf O, Zhang C, Robrecht S, et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 5- year results of the randomized CLL14 study. Presented at: 2022 EHA Congress; June 9-17, 2022; Vienna, Austria. Abstract S148

Articles

An updated safety and efficacy analysis of the ongoing CLL14 trial showed that venetoclax plus obinutuzumab continues to be an effective treatment for patients with chronic lymphocytic leukemia and coexisting conditions.

Venetoclax/Obinutuzumab Continues to Show Efficacy in Unfit Patients with CLL 

Early responses were reported among patients with heavily pretreated, advanced non–small cell lung cancer (NSCLC) without 

-activating mutations who received patritumab deruxtecan, according to results from the dose-expansion cohort of an ongoing phase 1 study (NCT03260491). Further, the results showed that clinical activity was observed in patients with other identified driver genomic alterations.

“Patritumab deruxtecan showed promising clinical activity in heavily pretreated patients with advanced NSCLC with or without identified variant genomic alterations,” said lead author Conor E. Steuer, MD, an assistant professor in the department of hematology and medical oncology at Emory University School of Medicine in Atlanta, Georgia, in a presentation of the data at the 

. “Some of this antitumor activity was found to be quite durable.”

At the January 28, 2022, data cut-off date, the confirmed overall response rate (ORR) by blinded independent central review (BICR) per RECIST 1.1 was 28.6% (95% CI, 11.3%-52.2%) among patients with identified genomic driver alterations (n = 21). The disease control rate (DCR) in this cohort of patients was 76.2% (95% CI, 52.8%-91.8%) and the median time to response was 2.8 months (range, 1.3-4.6). The median duration of response (DOR) was 9.4 months (95% CI, 4.2-not evaluable [NE]) and the median progression-free survival (PFS) was 10.8 months (95% CI, 2.8-16.0).

In patients without identified genomic driver alterations (n = 26), the confirmed ORR was 26.9% (95% 11.6%-47.8%) and the DCR was 73.1% (95% CI, 52.2%-88.4%). The median DOR was 9.6 months (95% CI, 1.6-NE) and the median PFS was 4.2 months (95% CI, 2.5-10.8). The median time to response was 2.1 months (range, 1.2-6.0).

The median follow-up time was 19.7 months (range, 13.8-29.2).

“These results demonstrate the promising clinical activity of patritumab deruxtecan in patients with NSCLC harboring a broad range of genomic alterations, or without identified genomic alterations,” Steuer said. “They warrant further clinical evaluation.”

He added that this was a heavily pretreated cohort, with an average of 3 (range, 1-8) previous lines of systemic therapy.

Investigators noted that 83% of NSCLC tumors express HER3, and that HER3 overexpression has been associated with poor clinical outcomes. Moreover, patients with advanced NSCLC without 

-activating mutations have limited options after treatment failure with]molecularly targeted therapies or platinum-based chemotherapy with or without immunotherapy.

Patritumab deruxtecan is an antibody drug conjugate composed of a fully human anti-HER3 IgG1 monoclonal antibody. The monoclonal antibody is covalently linked to a topoisomerase I inhibitor payload via a tetrapeptide-based cleavable linker.

The dose-expansion part (cohort 2) of the phase 1 trial enrolled patients with squamous or nonsquamous NSCLC that did not harbor the common 

 mutations, or without any identified driver genomic alterations. Patients with non-

 oncogenic alterations were eligible for the trial if they had undergone at least 1 previous treatment with targeted therapy, if available. All patients in the dose-expansion portion of the trial were treated with intravenous 5.6 mg/kg patritumab deruxtecan every 3 weeks.

The primary end point was confirmed ORR by BICR per RECIST 1.1. Secondary end points included DCR, time to response, DOR, PFS, and safety.

At the data cut-off date, 47 patients in cohort 2 with a median age of 62 years (range, 29-79) had been treated with patritumab deruxtecan. Most patients in the cohort were female (53.2%) and most had an ECOG performance status of 1 (66.0%). The median sum of diameters at baseline was 67 mm (range, 18-205) and 31.9% of patients had a history of central nervous system metastases. Disease histology included adenocarcinoma (74%), squamous (17%), large cell (2%), and other (6%).

All patients had undergone prior treatment with platinum-based chemotherapy, and 95.7% had received previous immunotherapy, including anti-PD-1/anti-PD-L1 treatment. One patient previously received an anti-CTLA-4 agent. Genomic-directed therapy was previously used in 19.1% of patients.

Five (10.6%) patients remained on study at data cut-off and 89.4% discontinued treatment. Primary reasons for discontinuation included progressive disease (51.1%), clinical progression (12.8%), adverse events (AEs; 10.6%), withdrawal of consent by patient (8.5%), and death (6.4%).

Steuer said treatment with patritumab deruxtecan was manageable and led to an overall safety profile consistent with previous findings in patients with 

-mutant NSCLC. Treatment-emergent adverse events (TEAEs) associated with treatment discontinuation occurred in 10.6% of patients. There were no drug-related deaths reported.

TEAEs that led to dose reduction or dose interruption were reported in 23.4% and 51.1% of patients, respectively. TEAEs associated with death occurred in 14.9% of patients and 40.4% of patients experienced serious AEs.

TEAEs of grade 3 or greater included neutropenia (26%), fatigue (17%), thrombocytopenia (15%), hypokalemia (13%), anemia (11%), leukopenia (11%), and pneumonia (11%). All patients experienced a treatment-related TEAE; none of these were associated with death. Slightly more than half (51.1%) of TEAEs were grade 3 or higher and 12.8% were serious TEAEs.

Five patients developed drug-related interstitial lung disease (ILD) by central adjudication with a median time to onset of 140 days (range, 43-331). Grade 1 ILD was reported in 2.1% of patients and grade 2 ILD in 8.5% of patients. No patients experienced grade 3 or greater ILD.

CE Steuer, H Hayashi, WC Su, et al. Efficacy and safety of patritumab deruxtecan (HER3-DXd) in advanced/metastatic non-small cell lung cancer (NSCLC) without EGFR-activating mutations. 

. 2022;40(suppl 16):9017. doi:10.1200/JCO.2022.40.16_suppl.9017

Regardless of other identified driver genomic alterations, patients with heavily pretreated, advanced, non–small cell lung cancer achieved encouraging responses with patritumab deruxtecan.

Patritumab Deruxtecan Produces Early Responses in Advanced NSCLC Regardless of Variant Genomic Alterations

Although patient-reported outcomes (PROs) have been utilized in the cancer space for decades, their use was frequently limited to standardized questionnaires which were filled out with pen and paper. Today, the evolution of PRO collection allows providers to gain a clearer view of how their patient is faring—both physically and mentally —with their diagnosis and corresponding treatment regimen, while also guiding the path towards more personalized and effective treatment regimens.

“PROs are where a question is asked of the patient and the patient responds in an unassisted way,” said Ishwaria M. Subbiah, MD, MS, a medical oncologist and palliative care and integrative medicine physician at The University of Texas MD Anderson Cancer Center (MD Anderson) in Houston, in an interview with 

PROs encompass a wide variety of signs, symptoms, and feelings. Examples in clinical oncology practice include the measuring of pain, daily activity levels, appetite, and dietary habits, among many others, with new innovations making their reporting more accurate, instantaneous, and clinically effective.

PRO Innovations Affecting Clinical Practice and Outcomes

The telehealth revolution spurred by the COVID-19 pandemic has touched nearly every aspect of cancer care and health care in general, and PROs are no exception. Mobile apps, online platforms, artificial intelligence–driven algorithms, and other innovations aimed at gathering PROs in a more convenient way for patients and clinicians are becoming commonplace.

“Technology has penetrated health care in a way that is unprecedented when it comes to the patients,” Subbiah said. “On the back end, as clinicians, we have seen how technological advances change how we deliver health care, as well as how we transmit information amongst clinical teams and across institutions.”

An effective new entry in PRO collection has arrived in the form of online reporting software, such as the electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) system. eRAPID is designed to provide patients with a secure online platform that is accessible from their home computer or other internet-capable device. The system is programmed with an automated clinical algorithm which delivers advice for symptom management or a prompt to call for assistance based on symptom severity.

Investigators evaluated eRAPID in a phase 3 trial (ISRCTN88520246) in combination with standard care in 508 patients with mostly early-stage cancers who were being treated with curative intent. The trial included patients with colorectal, breast, or gynecological cancers who were planning to receive chemotherapy and had internet access. The investigators randomly assigned the patients 1:1 to receive either standard care (n = 252) or standard care plus eRAPID (n = 256).

In the study, standard care included receiving verbal and written treatment information during in-person visits with an oncologist, regular assessment via telephone or in clinic, and contact with the hospital using an emergency hotline. Patients in the experimental arm completed online symptom-related questions from home over a period of 18 weeks, with weekly reminders being sent via text message and email. The patients’ symptom reports were relayed to their care team in real time using an electronic patient records system.

The primary end point of the trial was symptom control assessed by the Functional Assessment of Cancer Therapy-General, Physical Well-Being subscale at 6, 12, and 18 weeks. Secondary end points included processes of care, patient self-efficacy, and quality of life.

Results from the trial showed that eRAPID had a significant effect on improving patient physical well-being and self-efficacy and did not lead to a significant increase in hospital workload. eRAPID use led to improvement in physical well-being compared with usual care at 6 weeks (

 = .039). Patients who used eRAPID also had less clinically meaningful deterioration of physical well-being at 12 weeks vs patients who received usual care (47% vs 56%).

The average patient adherence with weekly symptom reporting was 64.7%. Although eRAPID participation was not associated with a difference in process of care, patients who used the intervention reported better overall health-related quality of life by the EQ visual analogue scale at 12 weeks (

 = .0302) compared with those who received usual care.

“PROs are impactful when they measure symptoms,” Subbiah said. “Where the impact has truly been dramatic is when patients are asked this question remotely between clinic visits when they are not face to face with a health care team member. Through remote symptom monitoring, patients can mark how they are doing specifically using numbers. When we receive that information as a clinical team, we can see where their symptom intensity is today compared with where it was yesterday, or a week ago, or 2 weeks ago. This is important because then you can pick up changes in how they are doing when the change is subtle vs when it is more severe.”

PRO reporting systems designed specifically for mobile device apps have also gained traction as smartphones have become increasingly commonplace among patients of all ages. One such app is SeamlessMD, a Health Insurance Portability and Accountability Act–compliant cloud-based platform that enables clinicians to provide patients with education and symptom monitoring services that patients can access via their smartphone.

Kneuertz et al tested the utility of SeamlessMD for patient engagement and PRO assessment following robotic surgery for lung cancer. The app was customized to cater to the requirements of the thoracic enhanced recovery pathway and included measures for preoperative preparation, in-hospital recovery, and postoperative discharge care.

The study included 50 adult patients with a diagnosis of or suspected lung cancer who were scheduled for robotic lung resection. SeamlessMD was made available on Apple and Android devices and the study allowed patients to designate a proxy, such as a spouse or child, if they were unable to use the app by themselves. Questions and tasks prompted on SeamlessMD were personalized to the needs of the individual patient and included daily symptom assessments, educational measures, exercise regimens, and recovery progress checks. Of 20 patients who returned the preoperative adherence survey, 85% reported receiving wound education and 95% adhered to some or all of the daily exercise programs. The postoperative health reports were completed by 27 patients, with a median of 3 (range, 0-17) completed surveys per patient.

Results from the postoperative health checks showed that the intervention was effective at improving patients’ confidence in their treatment regimen: 85.2% of patients reported improved confidence and 81.5% expressed decreased levels of worrying after completing the checks. A significant number of patients (40.9%) also said that the app’s health checks helped them avoid 1 or more phone calls to their care team, and 18.2% of patients said the checks helped them avoid at least 1 hospital visit.

Overall, patient satisfaction with SeamlessMD was high; 74.2% of patients who completed the preoperative survey (n = 31) found the app very helpful in terms of preparing themselves for their procedure. Among patients who completed the in-hospital survey (n = 31), 74.2% found the app extremely useful or very useful while they were in the hospital. Finally, after discharge, most of the 33 patients who were surveyed (78.8%) found SeamlessMD extremely or very useful post discharge and all patients said they would definitely or probably recommend the app. “There are many third-party applications that are in this space,” Subbiah noted. “The common theme [among them] is they want it to be as user friendly as possible for the patients. They want to ask good questions so that you get answers that, as a clinical team member, [you can] actually interpret and use.”

Effectively applying PRO measures, both new and old, is not without its challenges for clinicians, patients, and institutions. According to Subbiah, factors such as a patient’s comfort level with and access to necessary technology, accuracy in the self-reporting of symptoms, and the variety and differences among PRO collection methods all serve as potential barriers to effectively harnessing PROs.

To address some of the challenges presented by PROs, MD Anderson formed the Patient Survey Informatics Committee, which Subbiah chairs. The committee is tasked with overseeing the implementation of PROs across the institution and applying them to clinical practice and grew out of a need for remote symptom monitoring oversight and guidance.

Oncologists, patient experience team members, patient educators, clinical nurses, and legal team members all have a presence on the Patient Survey Informatics Committee, Subbiah noted. He added that the committee works to refine how questions are presented to patients, ensure with clinicians that questions are clinically validated, avoid question redundancy, and optimize workf lows related to PROs.

According to Subbiah, a major innovation ongoing in the realm of PROs is their increasing synchronicity with biometric data. By definition, PROs are written responses; however, Subbiah argues that dynamic PRO capture methods that take into account changes the patient may not immediately recognize themselves can increase the speed and quality of care.

“[PROs] can be patients answering [questions but can also include] wearing a sensor, monitor, or watch device that has biometric [capabilities],” Subbiah said. “Clinicians can get objective information [such as] step counts, activity levels, sleep quality, heart rate, oxygen levels, and blood pressure. [The goal is] to get information on how a patient is doing when they are not right in front of you. We know things change; we know health is dynamic.”

One such measure that combines traditional PROs with biometric data was tested in the HOPE pilot study (NCT03022032). Ten patients with gynecologic cancers who received palliative chemotherapy wore accelerometers to evaluate their physical activity. To record PROs, investigators used the Beiwe research platform, which monitors activity passively using a smartphone’s sensor to trigger surveys. This enabled data to be collected without any direct involvement from the patient, in addition to the PROs filled out by patients.

Results showed that the combination of PROs and active monitoring of patients’ heart rates and daily steps identified patient behavior patterns and suggested poor health in 2 patients. Specifically, drops in step patterns and disruptions in circadian behavior were observed in a patient who had severe nausea and vomiting. The system prompted a survey from the care team and the patient was contacted to manage symptom burden at home.

Most patients (n = 9) said they would recommend the app to a friend going through treatment. Clinicians and patients also reported that the HOPE study had a positive effect on the physical activity of patients, communication, and symptom management.

“[PROs] are an area of rapid evolution; it is one of the exciting areas [in cancer care],” Subbiah said. “A patient’s health and well-being are not static between clinic visits; we know that change has happened. The key is innovation that captures those changes as early as possible. [PROs and biometric data] have independently existed for years, but merging them, interpreting them, and correlating that merger with clinical outcomes— that is new and exciting.”

1. Absolom K, Warrington L, Hudson E, et al. Phase III randomized controlled trial of eRAPID: eHealth intervention during chemotherapy. 

. 2021;39(7):734-747. doi:10.1200/JCO.20.02015

2. Kneuertz PJ, Jagadesh N, Perkins A, et al. Improving patient engagement, adherence, and satisfaction in lung cancer surgery with implementation of a mobile device platform for patient reported outcomes. 

. 2020;12(11):6883-6891. doi:10.21037/jtd.2020.01.23

3. Wright AA, Raman N, Staples P, et al. The HOPE pilot study: harnessing patient-reported outcomes and biometric data to enhance cancer care. 

This article was originally published on 

 as “Innovations in Patient-Reported Outcomes Lead to Better Care.”

Patient-reported outcome collections continue to yield more effective and personalized treatments for patients with cancer. 

Revolutionizing Patient-Reported Outcomes in Oncology Care 

The use of a gonadotropin-releasing hormone (GnRH) agonist for ovarian suppression has become a more go-to treatment strategy to proactively help women with breast cancer from experiencing premature menopause.

Premature menopause is unfortunately a common long-term adverse effect (AE) of chemotherapy treatment.

“A woman who initially [receives a] diagnosis [of breast cancer] while premenopausal who undergoes chemotherapy will come out of that chemotherapy with ovaries that are not as highly functioning as they were before,” Kathryn Ruddy, MD, a consultant in the Division of Medical Oncology, Department of Oncology, at the Mayo Clinic in Rochester, Minnesota, said in an interview with 

®. “For some patients, that means they go into an immediate menopause during chemotherapy. For others, it may mean that they do not go into menopause, but their ovarian function and their fertility will not be the same as it [was before]. They also often will go through menopause earlier than they would have otherwise for this because of this ovarian toxicity.”

The American Society of Clinical Oncology (ASCO) guidelines for fertility preservation in patients with cancer recommend oncologists discuss the possibility of infertility as soon as possible before commencing treatment. The guidelines cite embryo cryopreservation, cryopreservation of unfertilized oocytes, ovarian transposition, and conservative gynecologic surgery as proven methods for fertility preservation.

The ASCO guidelines include recommendations for ovarian suppression with a GnRH agonist or other agent for fertility preservation when proven methods are not feasible. Ovarian suppression was cited as an option for young women with breast cancer to reduce the incidence of ovarian insufficiency caused by chemotherapy toxicity.

“The field of fertility preservation is fairly new when we think about [it, arising within the past] 1 or 2 decades, but has really taken off,” Zaraq Khan, MBBS, a reproductive endocrinologist in the Department of Obstetrics and Gynecology at the Mayo Clinic, said in an interview with 

®. “We look at the gold standard being egg or embryo freezing. Embryo freezing is considered a little bit better than egg freezing because when we thaw embryos, they thaw better than an egg. [There is also] ovarian tissue freezing, [which] has been going on in Europe for quite some time and has now become clinical practice in the US as well.”

The Role of GnRH Agonists in Premenopausal Breast Cancer

GnRH agonists function by downregulating GnRH receptors in the pituitary gland which suppresses the release of luteinising hormone and follicle-stimulating hormone (FSH). The suppression of these hormones reduces the production of oestradiol in the ovaries.

“The goal is to reduce estrogen when you are treating patients with breast cancer for hormone sensitive breast cancer,” Ann H. Partridge, MD, MPH, said in an interview with 

®. “When you are trying to preserve ovarian function, the goal is to stop ovulation. If you stop ovulation, the theoretical belief is that [using a GnRH agonist] you put the ovaries to sleep, so to speak. Therefore, there may be [reduction in the] effect of the chemotherapy on sleeping ovaries than there would have been on active, cycling ovaries through chemotherapy.”

Partridge is the vice chair of medical oncology, founder and director of the Program for Young Adults with Breast Cancer, and the director of the Adult Survivorship Program at Dana-Farber Cancer Institute in Boston, Massachusetts.

GnRH agonists have been evaluated for efficacy and safety in patients with breast cancer in several trials, however the only trial to date that reported number of pregnancies as a preplanned end point was the phase 3 POEMS trial (NCT00068601).

Results from the POEMS trial showed that premonpausal patients with breast cancer treated with the GnRH agonist goserelin (Zoladex) plus chemotherapy (n = 105) experienced a 70% reduction in ovarian failure at 2 years on study vs those who received chemotherapy alone (n = 113). Additionally, the 5-year cumulative incidence of pregnancy was 23.1% (95% CI, 15.3%-31.9%) compared with 12.2% (95% CI, 6.8%-19.2%), respectively (

Updated survival findings also favored treatment with goserelin plus chemotherapy; the 5-year overall survival (OS) with the combination was 91.7% (95% CI, 84.0% -95.8%) compared with 83.1% (95% CI, 74.4%-89.0%) with chemotherapy alone. The adjusted hazard ratio for disease-free survival (DFS) was 0.72 (95% CI, 0.39-1.32; 

The primary end point of the trial was the rate of ovarian failure and FSH levels in the postmenopausal range at 2 years. Ovarian failure was defined as amenorrhea for the preceding 6 months. Secondary end points included pregnancy within 5 years and ovarian dysfunction, defined as amenorrhea for the preceding 3 months and FSH, estradiol, or inhibin B levels in the postmenopausal range.

The median age for patients treated with the combination was 38 years (range, 25-49) vs 37 years (range, 26-48) for patients who received chemotherapy alone. The median follow-up time was 5.07 months (range, 0.44-10.89) and 5.04 months (range, 0.13-11.1), respectively.

In terms of safety, previously reported findings found that the combination of goserelin plus chemotherapy was found to be well tolerated. Among 103 patients evaluable for safety, common grade 2 AEs included hot flashes (n = 29), headaches (n = 12), vaginal dryness (n = 12), and sweating (n = 7). Grade 3 hot flashes occurred in 4 patients and the only grade 4 AE was 1 instance of thromboembolism.

Comparatively in the safety-evaluable chemotherapy arm (n = 111), common AEs included hot flashes (n = 14), vaginal dryness (n = 9), and sweating (n = 7). Grade 3 AEs consisted of hot flashes (n = 3), agitation (n = 1), joint paint (n = 1), and headache (n = 1). No grade 4 AEs were reported.

Additional results from other clinical trials have shown that ovarian suppression therapy in combination with other treatment modalities led to survival benefits and a decreased risk of recurrence among premenopausal patients with breast cancer. Combined data from the phase 3 SOFT (NCT00066690) and TEXT (NCT00066703) trials evaluated the long-term benefits of ovarian suppression in patients with hormone receptor–positive breast cancer.

The TEXT trial randomly assigned women within 12 weeks of surgery to 5 years to receive adjuvant treatment with the aromatase inhibitor exemestane (Aromasin) plus ovarian function suppression via the GnRH agonist triptorelin (Trelstar) or tamoxifen plusovarian function suppression. Treatment with chemotherapy was optional and was administered concurrently with ovarian function suppression therapy.

In SOFT, patients were randomized to be treated with either exemestane plus ovarian function suppression therapy via triptorelin or oophorectomy, tamoxifen plusovarian function suppression, or tamoxifen alone. Treatment was given within 12 weeks of surgery if no chemotherapy was planned, or within 8 months of completing neoadjuvant chemotherapy.

The primary end point of the combined analysis was DFS. Secondary end points included invasive breast cancer-free interval (BCFI), OS, and distant recurrence-free interval (DRFI).

At the May 2021 data cutoff date, the 12-year DFS rate was 80.5% in the combined exemestane plus ovarian function suppression population (n = 2346) compared with 75.9% among the 2344 patients in the combined tamoxifen plusovarian function suppression arm (HR, 0.79; 95% CI, 0.70-0.90). There was also a 4.1% improvement in 12-year BCFI and a 1.8% improvement in 12-year DRFI in the exemestane plus ovarian function suppression population compared with tamoxifen plusovarian function suppression.

Investigators also noted an emerging OS benefit for patients treated with exemestane plus ovarian function suppression compared with tamoxifen plusovarian function suppression among patients with HER2-negative disease who also were treated with chemotherapy in both trials. In SOFT, the 12-year OS rates were 84.4% and 81.1%, respectively. In TEXT, the 12-year OS rates were 86.8% and 83.5%, respectively.

Determining which patients are suited for treatment with a GnRH agonist or other ovarian suppression treatment for the purpose of preserving fertility can be challenging as some debate still remains as far as precisely which patients this treatment is right for. More proven options such as embryo or unfertilized oocytes cryopreservation remain the preferred option in this field. However, factors such as cost, timing, and the need for a partner can limit the fertility preservation options for younger patients. For this patient population, ovarian suppression with a GnRH agonist may present a more accessible option and can still be used in addition to established fertility preservation measures.

“Reproductive endocrinologists really make the ultimate decision about what the best strategy for fertility preservation is for any individual,” Ruddy said. “Again, the gold standard for almost [every patient] would be egg harvesting and freezing, but that is not always feasible for all women. Some women decide to receive GnRH agonists in addition to egg harvesting. So they are not necessarily mutually exclusive. There are probably more women using GnRH agonists in the setting of hormonally insensitive tumors, although I cannot say that I have seen data on that. I would defer to reproductive endocrinology and the preferences of an individual patient.”

Moore HCF, Unger JM, Phillips KA, et al. Final analysis of the prevention of early menopause study (POEMS)/SWOG intergroup S0230. 

. 2019;111(2):210-213. doi:10.1093/jnci/djy185

Oktay K, Harvey BE, Partridge AH, et al. Fertility Preservation in Patients with Cancer. 

. Published online April 5, 2018. doi:10.1200/JCO.2018.78.1914

Robertson JFR, Blamey RW. The use of gonadotrophin-releasing hormone (GnRH) agonists in early and advanced breast cancer in pre- and perimenopausal women. 

. 2003;39(7):861-869. doi:10.1016/s0959-8049(02)00810-9

Moore CF, Unger JM, Phillips KA, et al; POEMS/S0230 Investigators. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy

. 2015; 372(10):923-932. doi:10.1056/NEJMoa1413204

Regan MM, Walley BA, Fleming GF, et al. Randomized comparison of adjuvant aromatase inhibitor exemestane (E) plus ovarian function suppression (OFS) vs tamoxifen (T) plus OFS in premenopausal women with hormone receptor-positive (HR+) early breast cancer (BC): update of the combined TEXT and SOFT trials. 

. 2022;82(suppl 4):GS2-05. doi:10.1158/1538-7445.SABCS21-GS2-05

This article was originally published on OncLive as “Ovarian Suppression with GnRH Agonists Can Aid Fertility Preservation in Breast Cancer”

Current ASCO guidelines recommend that providers discuss the possibility of infertility with their patients as soon as possible before treatment begins. 

GnRH Agonists Demonstrate Utility in Preventing Premature Menopause in Women With Breast Cancer

Patients with myelofibrosis who have moderate or severe thrombocytopenia experienced physical function–related symptoms including tiredness and inactivity, according to a retrospective analysis of the phase 3 PERSIST-2 study (NCT02055781) presented at the National Comprehensive Cancer Network (NCCN) 2022 Annual Conference. However, pacritinib, which has been recently approved by the FDA, seeks to fill an unmet symptom burden need for this patient population, according to investigators.

“Tiredness and inactivity represent the most prevalent burden for patients with myelofibrosis with moderate to severe thrombocytopenia,” Ruben A. Mesa, MD, director of The University of Texas Health San Antonio MD Anderson Cancer Center, said.

Data from the analysis showed that tiredness was the most severe symptom in the overall population (N = 259) with a median symptom severity score of 6. Patients with moderate or severe baseline thrombocytopenia were included and stratified by baseline platelet count; 50-100 × 10

/L (n = 118) vs less than 50 × 109/L (n = 141).

Patients with severe thrombocytopenia had a higher combined median score of tiredness plus inactivity compared with patients with moderate thrombocytopenia, 12 vs 10, respectively (

Investigators of the PERSIST-2 study (NCT02055781) evaluated the safety and efficacy of the oral JAK2 inhibitor pacritinib (Vonjo) in adult patients with primary or secondary myelofibrosis. To be eligible for the trial, patients needed to have a platelet count of 100 × 10

/L or less. Prior treatment with a JAK2 inhibitor was permitted.

The trial randomized a total of 311 patients 1:1:1 to receive pacritinib 400 mg once daily, pacritinib 200 mg twice daily, or best available therapy. The coprimary end points of the trial were spleen volume response of at least a 35% at week 24 and at least a 50% total symptom score (TSS) reduction at week 24.

On February 28, 2022, the FDA granted pacritinib an accelerated approval for the treatment of adults with intermediate or high-risk primary or myelofibrosis with a platelet count below 50 × 10

/L. The approval was based on results from PERSIST-2.

In the analysis presented at the NCCN 2022 Annual Conference, symptom scores were evaluated using TSS 2.0 and were averaged for the week prior to randomization. Symptom prevalence was defined by a symptom score of at least 1 on a scale of 1 to 10.

Patients in the moderate group had a median age of 69 years (range, 64-74) compared with 67 years (range, 62-74) in the severe group. The median platelet count in moderate group was 28 × 109/L (range, 18 × 10

/L) among patients with a higher platelet count. Median hemoglobin was comparable in both arms, 9.2 g /dL (range 8.2 g/dL to 10.6 g/dL) and 9.4 g/dL (range, 8.4 g/dL to 11.0 g/dL) in the lower and higher platelet count arms, respectively. Patients with peripheral blasts of at least 1% were more common in the moderate cohort (48.2%) compared with the severe group (40.7%).

Patients with moderate thrombocytopenia had a mean TSS score of 22 and the average TSS score in this group was 23.7 (range, 4.0-58.4). Similarly, patients with severe thrombocytopenia had a median TSS score of 23 and the average TSS score was 25.7 (range, 3.0-64.3).

Additional results from the analysis showed that inactivity had a symptom severity score of approximately 5.5 and approximately 4.5 among patients in the moderate and severe cohorts, respectively. In terms of spleen-related symptom severity, patients with moderate thrombocytopenia had median symptom severity scores of approximately 5 for early satiety, approximately 3 for abdominal discomfort, and 2.5 for left rib pain. For patients with severe thrombocytopenia, these scores were approximately 5, approximately 4, and approximately 2, respectively.

Patients with moderate disease also had higher median symptom severity scores compared with those with severe disease for the cytokine-related symptoms of night sweats (approximately 3 vs approximately 2.5, respectively) and bone pain (approximately 2 vs approximately 1.5, respectively).

All symptoms examined in the analysis had a prevalence of at least 50% at both platelet levels. Common symptoms in the moderate group included tiredness (approximately 95%), inactivity (approximately 90%), early satiety (approximately 90%), abdominal discomfort (approximately 80%), and night sweats (approximately 70%). Among patients with severe thrombocytopenia common symptoms were made up of tiredness (approximately 95%), inactivity (approximately 85%), early satiety (approximately 85%), abdominal discomfort (approximately 75%), and night sweats (approximately 70%).

“As pivotal phase 2 studies for the JAK1/2 inhibitors ruxolitinib [Jakafi] and fedratinib [Inrebic] excluded patients based on lower platelet counts less than 50,000/µL or 100,000/µL, respectively, an unmet need remains for therapies that can improve symptomatic disease with myelofibrosis and limits [the effect] to their platelet count; pacritinib may fill this role,” Mesa said. “These data are even more relevant in light of the recent approval of pacritinib for patients with a platlet count of less than 50,000/µL.”

Specifically, pacritinib showed a marked spleen volume reduction of at least 35% compared with BAT. Among Investigators individuals with a platelet count of less than 50 × 10

/L, those who received pacritinib at the recommended 200-mg twice-daily dose (n = 31), 29.0% (95% CI, 14.2%-48.0%) had a reduction in symptom burden vs 3.1% (95% CI, 0.1%-16.2%) of those who received BAT (n = 32).

In terms of TSS, 26% of patients who received pacritinib had a reduction of at least 50% using the Modified Myelofibrosis Symptom Assessment Form compared with 9% of those who received BAT.

Mesa R, Palmer J, Bose P, et al. Symptom burden in patients with myelofibrosis who have moderate or severe thrombocytopenia: a retrospective analysis of patients enrolled in the PERSIST-2 study. 

. 2022;20(3.5):CLO22-067. doi:10.6004/jnccn.2021.7287

CTI BioPharma announces FDA accelerated approval of Vonjo (pacritinib) for the treatment of adult patients with myelofibrosis and thrombocytopenia. News release. CTI BioPharma. February 28, 2022. Accessed April 14, 2022. 

Vonjo. Prescribing information. CTI BioPharma Corp; 2022. Accessed April 15, 2022. bit.ly/3tO1bqm

Pacritinib helps relieve physical function-related symptoms in adult patients with myelofibrosis and moderate or severe thrombocytopenia.

Newly Approved Pacritinib Continues to Reduce Symptom Burden in Myelofibrosis With Moderate/Severe Thrombocytopenia

Patients with advanced ovarian cancer, regardless of biomarker status, experienced encouraging responses after receiving niraparib (Zejula) in combination with bevacizumab (Avastin) as a second-line treatment following platinum-based chemotherapy, according to findings presented in an updated analysis of the phase 2 OVARIO study (NCT03326193) during the 2022 SGO Annual Meeting on Womens’ Cancer.

Furthermore, the combination has demonstrated a safety profile consistent with that typically observed with each agent as a monotherapy, according to Melissa Hardesty, MD, MPH.

At the data cutoff point, in June 2021, the PARP inhibitor niraparib plus the VEGF inhibitor bevacizumab yielded a median progression-free survival (PFS) of 19.6 months (95% CI, 16.5-25.1). Moreover, the 18-month PFS rate was 62% (95% CI, 52%-71%) and the 24-month PFS rate was 53% (95% CI, 43%-63%). Overall, the median follow-up time was 28.7 months (interquartile range, 23.9-32.5).

“OVARIO enrolled a high-risk population,” said Hardesty, a gynecologic oncologist with Alaska Women’s Cancer Care in Anchorage. “More than half of the patients remained progression-free at 24 months. Clinical benefit [by PFS] was observed in the overall population, and across biomarker subgroups in a continuum.”

OVARIO enrolled patients with high-grade serous or endometrioid stage IIIB to IV epithelial ovarian, fallopian tube, or peritoneal cancer. Eligible patients achieved a complete response (CR), partial response (PR), or no evidence of disease (NED) result after treatment with front-line platinum-based chemotherapy plus bevacizumab.

Patients weighing less than 77 kg and/or with a platelet count below 150,000 per µL (n = 82) received niraparib 200 mg daily plus bevacizumab 15 mg/kg once every 3 weeks. All other patients (n = 23) were treated with niraparib 300 mg daily plus bevacizumab 15 mg/kg once every 3 weeks. All patients underwent tissue testing for HRD at enrollment.

The primary end point of the trial was PFS rate at 18 months. Secondary end points included median PFS, overall survival (OS), time to first therapy, and safety. PFS rate at 6 and 12 months were exploratory end points.

The median age of patients included in the trial was 60 (range, 37-82).Most patients had and ECOG performance status of 0 (63%), stage IIIC disease at diagnosis (68%), serous histology (95%). Investigators observed HRD positivity at a rate of 47%, and 63% of patients underwent prior treatment with neoadjuvant chemotherapy or IDS debulking surgery. A majority of patients had a CR or NED to their prior surgery or chemotherapy (58%) and 42% experienced a PR.

Results showed that the median time to first subsequent treatment was 17.5 months (95% CI, 14.5-20.7). Notably, median time to second progression was not evaluable (NE; 95% CI, 32.1-NE). OS data was immature at the time of the analysis, with an event rate of 23.8%.

Investigators noted a higher median PFS patients in HRD subgroup compared with the homologous recombination proficient (HRP) and homologous recombination not determined (HRnd) subgroups, 28.3 months (n = 49; 95% CI, 19.9-NE) versus 14.2 months (n = 38; 95% CI, 8.6-16.8) and 12.1 months (n = 18; 95% CI, 8-NE), respectively. Within the HRD subgroup, patients with 

alterations (n = 29) had a median PFS of NE (95% CI, 19.3-NE), while patients with 

wild-type mutations (n = 16) had a median PFS of 28.3 months (95% CI, 12.1-NE).

No new safety signals were observed with the combination; all patients experienced a treatment-related adverse event (TRAE) of any grade. Most patients (80%) had a TRAE of at least grade 3, with 77% of these determined to be related to niraparib and 51% attributed to bevacizumab. TRAEs leading to treatment interruption, dose reduction, or treatment discontinuation were reported in 88%, 74%, and 40% of patients, respectively.

The most common TRAEs of any grade included thrombocytopenia (70%), fatigue (57%), anemia, and nausea (both 52%). Commonly occurring TRAEs grade 3 or higher included thrombocytopenia (39%), anemia (34%), and hypertension (27%), among others.

Investigators also noted that treatment with niraparib plus bevacizumab resulted in no clinically meaningful impact on patient quality of life; the baseline score was 25.7 (standard deviation [SD], 3.79) with a mean change from baseline of -0.7 (SD, 0.35).

“There was no impact on quality of life as assessed by change in FOSI [Functional Assessment of Cancer Therapy-Ovarian Symptom Index] score,” Hardesty concluded.

Hardesty M, Krivak T, Wright GS, et al. OVARIO, a phase 2 study of niraparib + bevacizumab in advanced ovarian cancer following front-line platinum-based chemotherapy with bevacizumab: updated analysis. Presented at: SGO Annual Meeting on Women’s Cancer; March 18 -21, 2022; Phoenix, AZ. Abstract 40.

This article was published on OncLive as “Niraparib Plus Bevacizumab Shows Promise in High-Risk Ovarian Cancer Population”

The PARP inhibitor, niraparib, in conjunction with the VEGF inhibitor, bevacizumab, resulted in encouraging responses from patients with advanced ovarian cancer. 

Niraparib/Bevacizumab Combo Elicits Promising Responses in Advanced Ovarian Cancer, Regardless of Biomarker Status 

The ongoing phase 1b/2 FELIX trial (NCT04404660) is assessing the efficacy of the novel, second-generation chimeric antigen receptor (CAR) T-cell therapy obecabtagene autoleucel (obe-cel; AUTO1) in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). The goal of the study is to determine whether the agent might offer a durable treatment option for these patients—50% of whom will ultimately experience disease progression.

Other CAR T-cell treatment options exist for this patient population; however, despite being associated with initial responses to treatment, many are unable to deliver the necessary responses to improve prognoses for adult patients with relapsed or refractory disease.

Treatment with tisagenlecleucel (Kymriah), for example, did yield initial efficacy with durable remission and long-term persistence; study results were limited to pediatric patients. The CD19-directed CAR T-cell product was subsequently approved by the FDA on August 30, 2017, but its indication was for patients up to the age of 25 who had received at least 2 priori lines of therapy, or who had either progressed beyond or been unable to tolerate a second-generation TKI. 

Of note, the FDA also approved brexucabtagene autoleucel (Tecartus), a CD19–directed CAR T-cell therapy designed for use in adult patients with relapsed/refractory B-ALL, in 2021. The indication approves the use of the agent following the patient’s first relapse.

Investigators hope obe-cel will provide an additional CD19–directed CAR T-cell option to their arsenal.

 Obe-cel’s unique mechanism of action mimics physiological T-cell receptor interactions. The agent has a lower affinity for CD19 than similar CAR T products. This design helps to avoid CAR T-cell over-activation and exhaustion. Further, the half-life of the target interaction of obe-cel is 9.8 seconds compared with 21 minutes with tisagenlecleucel.5,6 In 2019, the FDA granted obe-cel an orphan drug designation.

“With obe-cel, [investigators] tried to develop a low-affinity CD19 binder that would allow the CAR T cells to rapidly bind and then release,” Bijal Shah, MD, MS, an associate member of the Department of Malignant Hematology at Moffitt Cancer Center in Tampa, Florida, said in an interview with 

®. “The hope was this would do 2 things: the first was that it would decrease [some of] the toxicity associated with CAR T-cell therapy, specifically cytokine release syndrome [CRS] and neurologic adverse effects [AEs]. [The second, that it] would improve the health of the T cell and limit T-cell exhaustion so the T cells can stay active for a longer period.”

Investigators previously evaluated obe-cel for safety and initial efficacy in the phase 1, single-arm, multicenter ALLCAR19 trial (NCT02935257). A total of 25 patients with relapsed/refractory B-ALL aged 16 or older underwent leukapheresis. The median age of participants was 41.5 years (range, 18-62) and most patients were male (65%). Patients had a median of 3 (range, 2-6) prior lines of treatment, including inotuzumab ozogamicin (Besponsa; 50%) and blinatumomab (Blincyto; 25%). Most had also received prior allogeneic hematopoietic stem cell transplantation (65%).

Twenty-four CAR T-cell products were manufactured, and 20 patients were ultimately infused with obe-cel. Prior to infusion, patients underwent lymphodepletion with 30 mg/m2 of intravenous fludarabine over 3 days and a single 60-mg/kg dose of cyclophosphamide. Obe-cel was given in a split-dose schedule; patients with more than 20% blasts received 10 × 106 CAR T cells and patients with blasts of 20% or less received 100 × 106 CAR T cells on day 0. The second dose was given at an interval of 9 days for a total dose of 410 × 106 CAR T cells.

Findings showed that the event-free survival (EFS) rates for patients who received obe-cel were 68.3% (95% CI, 42.4%-84.4%) at 6 months and 48.3% (95% CI, 23.1%-69.7%) at 12 months when measured by morphologic relapse criteria. This response was maintained at 24 months with an EFS rate of 68.3% (95% CI, 23.1%-69.7%). The overall survival (OS) rates were 69.1% (95% CI, 43.6%-84.8%), 63.8% (95% CI, 38.6%-80.8%), and 58.0% (95% CI, 33.1%-76.4%) at 6, 12, and 24 months, respectively. Additionally, 85% (95% CI, 62.1%-96.7%) of patients with a response (n = 20) achieved minimal residual disease (MRD)-negative complete response (CR) at month 1, and 70% (95% CI, 45.7%-88.1%) experienced an ongoing MRD-negative CR at month 3.

“What [investigators] are seeing with follow-up is that many of these responses are maintained,” Shah said. “The EFS looks like it is going to be about 1 year [based on the] curves, and that is outstanding; it is a signal for an effective CAR T-cell product. The CAR T cells also seem to persist over time, which seems to be encouraging in terms of helping to mitigate against subsequent relapse. We need to prove that, but the early data are certainly promising.”

In terms of safety, no cytokine release syndrome (CRS) events of grade 3 or higher were reported. Grade 1 and 2 CRS events were observed in 15% and 30% of patients, respectively. Investigators reported grade 4 thrombocytopenia among 70% of patients, and grade 1/2 and grade 3 in a small portion of patients (15%). All patients experienced an infection of any grade.

The tolerable safety profile of obe-cel coupled with high remission rates and persistence for adult patients with relapsed/refractory B-ALL provided the rationale for the FELIX trial.

During the 63rd American Society of Hematology Annual Meeting and Exposition, investigators presented initial efficacy and safety data from the phase 1b part of FELIX. At the data cutoff date of September 13, 2021, results showed that among the 16 patients who had been treated with obe-cel, the overall response rate (ORR) was 75% (95% CI, 48%-93%). At 1 month after obe-cel administration, 12 patients had achieved a CR or CR with incomplete recovery of counts, which was comparable with 85% of patients at the same point in the ALLCAR19 study.

In terms of safety, CRS of any grade was reported in 56% of patients; no grade 3 or greater CRS events were reported. Neurotoxicity of any grade was seen in 13% of patients, with 6% experiencing an event of grade 3 or higher. Grade 3 immune effector cell–associated neurotoxicity syndrome was reported in 1 patient.

The median age of patients included in the report was 42 years. Most patients had bone marrow blasts over 20% and had previously been treated with blinatumomab (75% and 56%, respectively). Twenty-five percent of patients had less than 5% bone marrow blasts.9 Autolus Therapeutics, the manufacturer of obe-cel, expects to present data from the pivotal phase 2 portion of the study in 2022.

The open label, multicenter, single-arm study is enrolling adult patients with relapsed or refractory B-ALL, with a target total of approximately 185 patients. All enrolled patients will sequentially complete screening, leukapheresis, preconditioning with cyclophosphamide and fludarabine chemotherapy, treatment, and follow-up stages. A total target dose of 410 × 106 CAR T cells is administered to all patients on day 1 and day 10 as a split dose, plus or minus 2 days.

Investigators hope that the novel obecabtagene autoleucel, a second-generation CAR T-cell therapy may fill an unmet need by representing a durable treatment option for patients with relapsed/refractory B-cell acute lymphoblastic leukemia. 

Kyle Doherty

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GnRH Agonists Demonstrate Utility in Preventing Premature Menopause in Women With Breast Cancer

Newly Approved Pacritinib Continues to Reduce Symptom Burden in Myelofibrosis With Moderate/Severe Thrombocytopenia

Niraparib/Bevacizumab Combo Elicits Promising Responses in Advanced Ovarian Cancer, Regardless of Biomarker Status

Investigational CAR T-Cell Therapy, Obecabtagene Autoleucel, Is Poised to Fill Unmet Need in Relapsed/Refractory B-ALL

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