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Michael Lai, ARNP, explained the mechanism of action of PARP inhibitors for the treatment of patients with prostate cancer.

Understanding the Mechanism of Action Behind PARP Inhibitors for Prostate Cancer

The Immune Effector Cell Encephalopathy score and keeping a close eye on patients’ symptoms are critical when monitoring for potential ICANS during lymphoma treatment.

Tools to Monitor for ICANS During Lymphoma Treatment With Bispecific Antibodies, CAR T-Cell Therapy

A multidisciplinary approach to adverse effect management addresses many needs patients with gynecologic cancers may have while undergoing treatment. 

‘Bringing Every Single Resource’ When Caring for Patients Receiving Treatment for Gynecologic Cancers

Applying diversity, equity, and inclusion to cancer clinics can help oncology nurses and APPs make an impact on patient care and research. 

Bringing DEI to Clinical Trial, Cancer Clinics Through Self-Awareness

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Patricia Jakel is an advanced practice nurse for the UCLA Santa Monica Solid Oncology Program. In 1997, she received the Advanced Practice Nurse of the Year Award from the ONS Los Angeles Chapter. She is an active member of American Nurses Association, the American Cancer Society, and the Oncology Nursing Society, and her personal research interests include survivorship, adverse event management, and quality-of-life improvement.

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Although excitement surrounds the constantly changing landscape of cancer care, we have much to learn to keep our practices current.

The Changing Landscape of Clinical Trials in Cancer Care

GC012F, a BCMA/CD19–targeted CAR T-cell therapy, safely produced favorable outcomes in patients with newly diagnosed multiple myeloma after induction therapy.

BCMA/CD19–Targeting CAR T-Cell Therapy Safely Produces Favorable Outcomes in Newly Diagnosed Multiple Myeloma

Merck has discontinued the KEYNOTE-867 and KEYNOTE-630 trials evaluating pembrolizumab in non-small cell lung cancer and cutaneous squamous cell carcinoma.

Two Phase 3 Trials of Pembrolizumab in NSCLC, CSCC to Be Discontinued By Merck

Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com

Companion diagnostics have been approved by the FDA for olaparib plus abiraterone in patients with metastatic castration-resistant prostate cancer.

Companion Diagnostics for Olaparib Plus Abiraterone Acetate Gains FDA Approval in BRCA+ mCRPC

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GCC’s Pharmacogenomics Program may help reduce side effects from chemotherapy for some patients

In the United States, only 27 institutions have been awarded the Gold level “Center of Excellence” by the International Cardio-Oncology Society (IC-OS).  The Cardio-Oncology Program at the Georgia Cancer Center is proud to be one of those 27 institutions.

Georgia Cancer Center’s Cardio-Oncology program gets the gold

The FDA approved first-line amivantamab-vmjw (Rybrevant) plus lazertinib (Lazcluze) to treat adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring 

 exon 19 deletions or exon 21 L858R substitution mutations.

The regulatory decision was supported by data from the phase 3 MARIPOSA trial (NCT04487080) which showed that amivantamab plus lazertinib reduced the risk of progression or death by 30 percent compared with osimertinib (Tagrisso; HR, 0.70; 95% CI, 0.58-0.85; 

 < .001). Patients treated with the combination (n = 429) experienced a median progression-free survival (PFS) of 23.7 months compared with 16.6 months for those treated with osimertinib (n = 429).

The objective response rate (ORR) was 86% (95% CI, 83%-89%) in the amivantamab/lazertinib arm vs 85% (95% CI, 81%-88%) in the osimertinib arm. The median duration of response (DOR) was 25.8 months (95% CI, 20.1–not estimable [NE]) in the experimental arm vs 16.8 months (95% CI, 14.8-18.5) in the control arm.

"This approval is a crucial development for patients with 

-mutated NSCLC, who have faced significant unmet needs for far too long," Jill Feldman, lung cancer survivor and co-founder of the EGFR Resisters, a patient advocacy group, stated in a news release.

 "Having witnessed firsthand the remarkable evolution in lung cancer treatment, this profoundly important milestone brings a novel therapeutic approach to patients and their families. I'm thrilled that more patients can now experience the PFS benefits seen in the MARIPOSA study."

MARIPOSA was an international, randomized trial that enrolled patients at least 18 years of age with previously untreated locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations. Patients were permitted to have asymptomatic or stable brain metastases.

Patients were randomly assigned 2:2:1 to receive amivantamab plus lazertinib, osimertinib monotherapy, or lazertinib monotherapy. Amivantamab was given at 1050 mg (or 1400 mg in those with a body weight of at least 80 kg) once per week for the first 4 weeks, which included a split of the first infusion over 2 days (350 mg on cycle 1, day 1, and the remainder given on cycle 1, day 2). In cycle 2 and beyond, amivantamab was given once every 2 weeks. Osimertinib at 80 mg and lazertinib at 240 mg given once per day.

Blinded independent central review–assessed PFS per RECIST 1.1 criteria for the combination arm vs the osimertinib arm served as the trial's primary end point. Secondary end points included overall survival (OS), ORR, DOR, and safety.

The median OS was NE in both the amivantamab/lazertinib and osimertinib arms (HR, 0.80; 95% CI, 0.61-1.05). The 18- and 24-month OS rates in the experimental arm were 82% (95% CI, 78%-85%) and 74% (95% CI, 69%-78%), respectively. In the osimertinib arm, those respective rates were 79% (95% CI, 75%-83%) and 69% (95% CI, 64%-74%).

Regarding safety, the most common adverse effects reported in at least 20% of patients treated with amivantamab/lazertinib were rash, nail toxicity, infusion-related reactions with amivantamab, musculoskeletal pain, edema, stomatitis, venous thromboembolism, paresthesia, fatigue, diarrhea, constipation, COVID-19 infection, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity.

Venous thromboembolic events were observed with lazertinib plus amivantamab, and the FDA recommended the use of prophylactic anticoagulation for the first 4 months of therapy.

The recommended dose for lazertinib is 240 mg once per day in combination with amivantamab with or without food. The recommended amivantamab dose is based on baseline body weight.

Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer. News release. Johnson & Johnson. August 20, 2024. Accessed August 20, 2024. https://www.investor.jnj.com/news/news-details/2024/RYBREVANT-amivantamab-vmjw-plus-LAZCLUZE-lazertinib-approved-in-the-U.S.-as-a-first-line-chemotherapy-free-treatment-for-patients-with-EGFR-mutated-advanced-lung-cancer/default.aspx

Cho BC, Lu S, Felip E, et al. Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC. 

. Published online June 26, 2024. doi:10.1056/NEJMoa2403614

FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer. FDA. August 19, 2024. Accessed August 20, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-amivantamab-vmjw-non-small-lung-cancer

First-line amivantamab plus lazertinib has been approved by the FDA for locally advanced or metastatic EGFR-mutated non–small cell lung cancer.

First-Line Amivantamab Plus Lazertinib Receives FDA Approval for EGFR-Positive Advanced NSCLC

Tumor-stroma proportion (TSP) may predict clinical outcome measures, including progression-free survival (PFS), platinum chemoresistance, and overall survival (OS), in high-grade serous ovarian cancer, according to findings from a retrospective analysis that were published in 

This prognostic study included tumors from 103 patients with ovarian carcinoma collected by The Cancer Genome Atlas (TCGA) that were diagnosed and treated at several institutions from 1993 to 2013; tumors from an independent cohort of resected diagnostic and tissue microarray clinical specimens from 192 patients with suspected or known high-grade serous ovarian carcinomas collected from 2004 to 2014 by the University of Tübingen in Germany were also assessed. No significant association between TSP levels and chemoresistance was observed in the TCGA cohort. In the Tübingen cohort, more patients with high TSP (34.1%; n = 14) were platinum resistant vs those with low TSP (14.6%; n = 22). Conversely, more patients with low TSP (85.4%; n = 129) were platinum sensitive vs those with high TSP (65.9%; n = 27).

TSP, defined as the extent of tumor involvement with stromatous tumor microenvironment components, has been associated with poor outcomes in several cancers.

 Furthermore, a prospective observational study published in 2019 demonstrated that 4 out of 5 newly diagnosed, platinum-resistant ovarian tumors harboring TSP exhibited a high TSP, in contrast to 5 out of 19 platinum-sensitive tumors (

“The discovery that high TSP was associated with platinum resistance offered TSP as a potentially effective and low-cost predictive biomarker of drug resistance that, if confirmed and validated, could advance the field of ovarian cancer treatment by helping to tailor treatment for patients in whom platinum therapy was predicted to be less effective than in others,” Emil Lou, MD, PhD, FACP, lead study author, and coauthors, wrote in the paper.

 “Thus, we next sought to confirm these results in a larger patient cohort.”

Lou is a medical oncologist, neuro-oncologist, and gastrointestinal oncologist, as well as an associate professor of medicine in the Division of Hematology, Oncology, and Transplantation at the University of Minnesota Medical School in Minneapolis.

This study was conducted from January 2021 to January 2024. The primary outcomes were the predictive ability of TSP for platinum chemoresistance, PFS, and OS.

TSP scoring was conducted by 1 clinician and 1 pathologist who identified the most densely populated cellular areas of each tumor specimen slide and labeled the relative amounts of tissue represented by cancer cells vs stromal tissue using 50% as a previously validated cutoff. Tumors with a stroma population of less than 50% were considered to have low TSP, and those with a stroma population of 50% or greater were considered to have high TSP. Stromal tissue that did not clearly correlate with the peritumoral stroma was excluded from the evaluation, and areas that were necrotic, empty, mucinous, or large and inflammatory were not included in TSP scoring.

Patients in the TCGA cohort had a mean age of 61.6 years (SD, 11.1), 70.9% had International Federation of Gynecology and Obstetrics (FIGO) stage III disease, and 73.8% had residual disease after surgical debulking. Furthermore, 11.7% and 30.1% of patients had chemoresistant disease and unknown chemoresistance status, respectively, which limited confirmation in this analysis. A total of 18 patients (17.5%) had high TSP, and the remaining 85 patients had low TSP. TSP levels were balanced across clinical and demographic characteristics.

Patients in the Tübingen cohort had a mean age of 63.7 years (SD, 11.1) at diagnosis, 69.8% had FIGO stage III disease, and 49.5% had node-positive disease. Moreover, 68.8% of patients had no evidence of distant metastasis, and 56.3% had residual disease after surgical debulking. Forty-one patients (21.4%) had high TSP, and 151 patients (78.6%) had low TSP. Fourteen patients (34.1%) with high TSP had FIGO stage IV disease at the time of initial diagnosis vs 22 patients (14.6%) with low TSP (

= .04). In both the TSP-high and -low groups, the most frequent T and N stages were T3C and N0, respectively; The authors noted that this may be explained by the higher rate of distant metastases in the high TSP group (34.1%) vs the low TSP group (14.6%; 

 = .01). TSP levels were balanced across age, tumor size, tumor number, and extent of affected lymph nodes.

All patients in the TCGA cohort underwent surgery followed by standard-of-care (SOC) adjuvant chemotherapy; no history of neoadjuvant chemotherapy was reported in this population. All patients in the Tübingen cohort underwent debulking surgical resection of their tumors followed by SOC systemic therapy.

In the TGCA cohort, high TSP following initial diagnosis and treatment was not associated with a worse PFS rate (HR, 1.661; 95% CI, 0.7661-3.603; 

= .20). Additionally, high TSP after the first several years from diagnosis was not associated with OS (HR, 1.906; 95% CI, 0.9622-3.776; 

= .06). The authors noted that since chemoresistance status was unknown or not listed for 31 patients in this cohort, further investigation using a larger and more complete dataset is needed to determine whether there is an association between high TSP and a worse PFS rate.

In the Tübingen cohort, when adjusted for primary metastasis, age at diagnosis, and the presence of residual disease, high TSP was associated with significantly lower PFS (HR, 1.586; 95% CI, 1.093-2.302; 

= .02) and OS (HR, 1.867; 95% CI, 1.249-2.789; 

Patients in the Tübingen cohort with low TSP were more likely to achieve PFS vs those with high TSP at all time points during follow-up (HR, 1.573; 95% CI, 1.090-2.270; 

= .02). The presence of residual disease following surgery was also associated with worse PFS rates (HR, 2.038; 95% CI, 1.436-2.892; 

< .001). However, the presence of distant metastases, which were more commonly observed in patients with high TSP, was not associated with PFS rates after adjusting for the contributions of other variables. Additionally, patients with low TSP had a higher OS rate at all time points excluding the initial months (HR, 0.726; 95% CI, 1.166-2.557; 

= .006). The presence of residual disease (HR, 2.604; 95% CI, 1.764-3.844; 

< .001), metastases (HR, 1.572; 95% CI, 1.040-2.375; 

= .03), and age (HR, 1.035; 95% CI, 1.018-1.052; 

< .001) were also associated with a lower OS rate.

Since several retrospective studies investigating reactive tumor stroma patterns use a tissue microarray (TMA)–based approach with available resection specimens, the investigators aimed to determine whether the TMA approach would generate the same results as whole-slide assessment, as differences in tumor preparation could lead to potential outcome differences. In this study, TMAs consisted of 6 0.8-mm diameter punches for each clinical specimen. Investigators assigned a single TSP category to each patient depending on the mode from their 6 TSP values. From this process, patients were classified as stroma-rich (high TSP) or stroma-poor (low TSP). A univariable analysis was conducted to compare PFS and OS rates for patients with high vs low TSP.

An analysis of TMAs from 185 patients from the Tübingen cohort, included 143 patients who were TSP low and 42 patients who were TSP high, translating to a 15.6% disparity in TSP levels between the whole-slide assessment and the TMA-based scoring. This univariable analysis showed an association between high TSP and significantly lower PFS (HR, 1.675; 95% CI, 1.012-2.772; 

= .04) and OS (HR, 2.491; 95% CI, 1.585-3.912; 

The investigators also used the Tübingen cohort to validate their 2019 findings that high TSP is associated with the emergence of resistance to platinum chemotherapy in patients with ovarian cancer. After adjusting for primary metastasis, age, and the presence of residual disease, this analysis found that patients with chemoresistant tumors were significantly more likely to have high TSP vs those with chemosensitive tumors (OR, 2.861; 95% CI, 1.256-6.515; 

= .01). The estimated area under the receiver operating characteristic curve for the model that predicted platinum chemotherapy resistance based on TSP, metastasis, age at diagnosis, the presence of residual disease, and lymph node spread was 0.7644 (95% CI, 0.639-0.889).

“Taken together, these results not only suggest that chemoresistance in patients with [high] TSP is associated with poorer outcomes also observed in these patients, but also suggest that TSP may have specificity and sensitivity high enough to be used in the clinical setting to predict which patients are going to respond to treatments or benefit from newer therapeutic options,” the authors emphasized.

The authors noted that limitations of this study include those inherent to using a retrospective dataset, as well as the inexact nature of assessing residual disease after attempted maximal cytoreduction and debulking and the manual process of assessing slides for TSP. Additionally, the small sample sizes of some of the patient subsets and the intratumoral heterogeneity of ovarian cancer warrant further evaluation of TSP levels in prospective validation studies.

“Here, we demonstrate that TSP serves as an additional stratifying factor for determining cases at highest risk of recurrence and death that are likely due in part to lack of efficacy of standard platinum-based chemotherapies. With this confirmation, we propose that TSP should be further standardized and incorporated into prospective clinical trials as a correlative predictive biomarker for drug resistance,” the authors concluded.

Lou E, Clemente V, Grube M, et al. Tumor-stroma proportion to predict chemoresistance in patients with ovarian cancer. 

. 2024;7(2):e240407.2024 Feb 5. doi:10.1001/jamanetworkopen.2024.0407

Micke P, Strell C, Mattsson J, et al. The prognostic impact of the tumour stroma fraction: a machine learning-based analysis in 16 human solid tumour types. 

. 2021;65:103269. doi:10.1016/j.ebiom.2021.103269

Lou E, Vogel RI, Hoostal S, et al. Tumor-stroma proportion as a predictive biomarker of resistance to platinum-based chemotherapy in patients with ovarian cancer. 

. 2019;5(8):1222-1224. doi:10.1001/jamaoncol.2019.1943

Progression-free survival and platinum chemoresistance may be predicted by tumor-stroma proportion in patients with high-grade serous ovarian cancer.

Tumor-Stroma Proportion May Predict Clinical Outcomes in High-Grade Serous Ovarian Cancer

Patients with newly diagnosed advanced ovarian cancer that did not harbor 

 mutations treated with durvalumab (Imfinzi) plus carboplatin, paclitaxel, and bevacizumab (Avastin), followed by maintenance therapy with olaparib (Lynparza) plus durvalumab and bevacizumab, continued to experience improved progression-free survival (PFS) vs chemotherapy plus bevacizumab, followed by maintenance bevacizumab, according to updated data from the phase 3 DUO-O trial (NCT03737643) presented at the 2024 ESMO Gynecological Cancers Congress.

Results from the final PFS analysis indicated that in patients with 

-unmutated, homologous recombination deficient (HRD)–positive disease, the median PFS was 45.1 months with durvalumab plus chemotherapy and bevacizumab, followed by maintenance olaparib, durvalumab, and bevacizumab (arm 3; n = 140) compared with 23.3 months for patients treated with chemotherapy plus bevacizumab, followed by maintenance bevacizumab (arm 1; n = 143; HR, 0.46; 95% CI, 0.33-0.65). Patients treated with durvalumab plus chemotherapy and bevacizumab, followed by maintenance durvalumab plus bevacizumab (arm 2; n = 148) achieved a median PFS of 25.1 months (HR vs arm 1, 0.89; 95% CI, 0.67-1.19).

-unmutated, intention-to-treat (ITT) population, the median PFS was 25.1 months for arm 3 (n = 578) vs 19.3 months for arm 1 (n = 378; HR, 0.61; 95% CI, 0.51-0.73). The median PFS for arm 2 (n = 374) was 20.6 months (HR vs arm 1, 0.87; 95% CI, 0.74-1.03; 

“DUO-O continues to demonstrate a clinically meaningful PFS benefit with first-line durvalumab, chemotherapy, and bevacizumab, followed by durvalumab, bevacizumab, and olaparib maintenance [in arm 3] vs the control [arm 1],” Fabian Trillsch, MD, of LMU Munich University Hospital in Germany stated during the presentation of data.

at a previously planned interim PFS analysis

 presented during the 2023 ASCO Annual Meeting, investigators shared that the investigational approach led to a statistically significant improvement in PFS compared with the control.

Patients with HRD-positive disease had a median PFS of 37.3 months in arm 3 compared with 23.0 months in arm 1 (HR, 0.49; 95% CI, 0.34-0.69; 

 < .0001). In the ITT population, the median PFS was 24.2 months in arm 3 vs 19.3 months in arm 1 (HR, 0.63; 95% CI, 0.52-0.76; 

The updated data included results from the final PFS analysis and an interim OS analysis, as well as an analysis of time to second progression (PFS2).

DUO-O enrolled patients with newly diagnosed, FIGO stage III to IV high-grade epithelial ovarian cancer who did not harbor 

 mutations, were treatment-naïve, and underwent primary debulking or planned interval debulking surgery.

The study included a run-in featuring treatment with carboplatin plus paclitaxel during cycle 1 before patients were randomly assigned 1:1:1. After the chemotherapy phase in each randomized arm, patients with a response, stable disease, or no evidence of disease were allowed to receive maintenance therapy. In arm 1, patients received carboplatin and paclitaxel plus bevacizumab prior to maintenance bevacizumab. Patients in arm 2 received durvalumab plus carboplatin, paclitaxel, and bevacizumab, followed by bevacizumab and durvalumab in the maintenance phase. In arm 3, patients received durvalumab plus carboplatin, paclitaxel, and bevacizumab, followed by maintenance bevacizumab, durvalumab, and olaparib.

The primary end point of the study was PFS per RECIST 1.1 criteria for arm 3 vs arm 1 in the HRD-positive and ITT populations. Key secondary end points included OS, PFS2, and safety.

The final PFS analysis was scheduled to be performed when PFS data in arms 3 and 1 reached 58% maturity in the HRD-positive population and 62% in the ITT population.

“In line with a previous analysis, we observed a PFS benefit for arm 3 vs arm 1 across the prespecified subgroup analysis in the 

-unmutated, HRD-positive population, [based on] stratification factors and other clinically relevant factors,” Trillsch reported. “Similarly, a PFS benefit for arm 3 vs arm 1 was also seen across the predefined subgroups in the 

In the HRD-positive population, the median OS was not reached (NR) in all 3 arms; however, trends favoring arm 3 vs arm 1 (HR, 0.84; 95% CI, 0.51-1.37; 

 = .48) and arm 2 vs arm 1 (HR, 0.69; 95% CI, 0.41-1.15) were observed.

In the ITT population, the median OS was 48.5 months in arm 3 vs 48.0 months in arm 1 (HR, 0.95; 95% CI, 0.76-1.20; 

 = 0.68). The median OS was NR in arm 2 (HR vs arm 1, 0.92; 95% CI, 0.73-1.16; 

In the HRD-positive cohort, the median PFS2 was NR for arm 3 vs 42.0 months for arm 1 (HR, 0.62; 95% CI, 0.40-0.95). The median PFS2 was 48.3 months in arm 2 (HR vs arm 1, 0.91; 95% CI, 0.60-1.36).

In the ITT cohort, the median PFS2 was 35.4 months in arm 3 vs 32.8 months in arm 1 (HR, 0.82; 95% CI, 0.67-1.01). The median PFS2 was 33.2 months in arm 2 (HR vs arm 1, 0.91; 95% CI, 0.75-1.12).

Regarding safety, findings were consistent with the primary analysis of the study. The most common grade 3 or higher adverse effects (AEs) in arm 3 were neutropenia (31%; arm 2, 28%; arm 1, 26%) and anemia (25%; 8%; 8%).

“DUO-O is ongoing, and further insight into the long-term benefit of the combination will be provided with additional follow-up,” Trillsch concluded.

Disclosures: Dr Trillsch reported receiving advisory board fees (personal) from AstraZeneca, ImmunoGen, GlaxoSmithKline, Eisai, and MSD; speaker fees and honoraria (personal) from AstraZeneca, GlaxoSmithKline, and MSD; travel support (personal) from AstraZeneca and GlaxoSmithKline; and research funding (institution) from AstraZeneca and SAGA Diagnostics.

Trilsch F, Okamoto A, Kim JW, et al. Durvalumab + carboplatin/paclitaxel + bevacizumab followed by durvalumab, bevacizumab + olaparib maintenance for newly diagnosed advanced ovarian cancer without a tumour BRCA1/BRCA2 mutation: updated results from DUO-O. Presented at: 2024 ESMO Gynecological Cancers Congress; June 20-22, 2024; Florence, Italy. Abstract 43O.

Harter P, Trillsch F, Okamoto A, et al. Durvalumab with paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm): results from the randomized, placebo (pbo)-controlled phase III DUO-O trial. 

. 2023;41(suppl 17):LBA5506. doi:10.1200/JCO.2023.41.17_suppl.LBA550

A durvalumab-based combination followed by an olaparib-based maintenance therapy improved progression-free survival in newly diagnosed advanced ovarian cancer without BRCA1/2 mutations.

Durvalumab Combo Before Olaparib Maintenance Boosts PFS in BRCA-Negative Ovarian Cancer

The FDA granted Radspherin fast track designation for the treatment of peritoneal metastases from ovarian cancer.

Alpha-emitting radiopharmaceutical Radspherin receives a fast track designation from the FDA for peritoneal carcinomatosis from ovarian cancer.

Georgia Cancer Center at Augusta University

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