Although there is still an unmet need in treatment for patients with multiple myeloma whose disease progressed after 1-3 prior lines of treatment and are lenalidomide (Revlimid)-refractory, the CAR T-cell therapy ciltacabtagene autoleucel may be able to fill that treatment gap, said Adam D. Cohen.

The CAR T-cell therapy was evaluated in the CARTITUDE-2 study, designed to evaluate its efficacy and safety. Initial results from cohort A of the trial were presented at the 18th International Myeloma Workshop by Coheh, associate professor at the University of Pennsylvania.

“These responses appear to be deepening over time and follow-up is ongoing,” he said. “Of course, what we’re all waiting for is the longer-term follow-up to see if the durability of response is going to be better in this less heavily treated population compared to the more refractory patients treated historically.”

Cohorts B, C, D, and E, for whom data are still under analysis, consist of patients with early relapse after frontline therapy who are progressing after a prior B-cell maturation antigen (BCMA)-targeted therapy, or as consolidation for patients after transplant or induction therapy.

The researchers’ primary objective was minimal residual disease (MRD) negativity of 10-5 sensitivity assessed by next-generation sequencing, with secondary objectives of overall response rate (ORR), duration of response, time and duration of MRD negativity, and incidence and severity of adverse events (AEs).

A single cilta-cel infusion was administered to 20 patients 5 to 7 days after the start of lymphodepletion. With a median follow-up of 5.8 months at data cutoff, ORR was 95%, including 75% of patients who achieved a complete response (CR) or better.

The safety profile was consistent with those observed in previous studies, with the majority of nonhematologic AEs being low grade. The most common grade 3/4 hematologic AEs included neutropenia (90%), thrombocytopenia (35%), anemia (40%), lymphopenia (55%), and leukopenia (55%). Grade 3/4 neutropenia and lymphopenia persisted after 60 days in 25% and 45% of patients, respectively.

Additionally, 85% of patients developed cytokine release syndrome (CRS), with the majority being grade 1 or 2 events. Several patients (15%) experienced typical CAR T-cell–related immune effector cell-associated neurotoxicity syndrome (ICANS).

“A number of mitigation strategies have been implemented in the CAR T program since then, including enhanced bridging therapy to reduce tumor burden prior to infusion early and aggressive treatment of CRS and ICANS, as well as handwriting assessments since microgravity was a presenting feature in some of the patients,” Cohen said.

The implementation of these strategies has significantly reduced the incidence of movement and neurocognitive disorders in the more than 100 additional patients who have been dosed in the time since data cutoff. However, follow-up is still ongoing, Cohen explained.

Cilta-cel continues to be evaluated in a phase 3 study, CARTITUDE-4, in which it is being compared with standard-of-care treatment.

Cohen A, Agha M, Madduri D, et al. Efficacy and safety of ciltacabtagene autoleucel, a BCMA-directed CAR-T cell therapy, in patients with progressive multiple myeloma after 1–3 prior lines of therapy: Initial results from CARTITUDE-2. Presented at: 18th International Myeloma Workshop; September 8-11, 2021; Vienna, Austria.

Articles

Patients with progressed multiple myeloma experienced deep and durble responses through CAR T-cell therapy ciltacabtagene autoleucel therapy. 


Cilta-cel CAR T-Cell Therapy May Satisfy Need For Deeper Treatment Responses in Multiple Myeloma 

An ongoing four-year study based out of the University of Wisconsin-Madison Carbona Cancer Center seeks to determine the best way to improve colorectal cancer screening rates in rural areas.

“Our goal is to learn from the clinics that are doing it correctly and doing well and see if we can take their strategies and help disseminate them to lower-performing health care settings that have similar access to resources, similar patient populations,” said lead researcher Dr. Jennifer Weiss, a gastroenterologist at the UW Carbone Cancer Center and associate professor at the University of Wisconsin School of Medicine and Public Health.



Researchers will survey, tour and interview at more than 200 rural primary care clinics in the upper Midwest. They’ll use early data showing which clinics are high performing (having successfully screened 80% or more eligible patients) to then identify common best practices at those clinics. They also plan to examine the potential causes or barriers leading to lower screening rates at certain clinics.

Weiss said that during her time as a gastroenterologist, she has seen a number of cases where a patient received a colorectal cancer diagnosis that could have been prevented with appropriate or timely screening.

“I think one of the things that people don't understand is we can actually prevent colorectal cancer,” she said. “Most people talk about breast cancer screening – with breast cancer screening, we're trying to identify a breast cancer at the earliest stage possible. With colorectal cancer screening, we can actually identify the precancerous lesion, which is a colon polyp, and take it out before it turns into a cancer.”

Weiss became more interested in health care system- and patient-level interventions to address screening issues. She and fellow researchers began their work in 2008, studying whether multilevel interventions at a large academic health center in a midsize city would help increase screening rates.

“We were able to increase our screening rates over 20% so that we’ve maintained over 80% screening rates for the last five years” Weiss said. “But I started to realize that what we were doing here at an academic health center might not be immediately applicable or transferable to other types of health care settings.”

As Wisconsin has a large rural community, Weiss set out to find a way to translate the lessons they’d learned from the 2008 study to rural clinics. The research is funded by a $1.2 million grant from the American Cancer Society in partnership with the Wisconsin Collaborative for Healthcare Quality.

Though the researchers won’t know for sure until the study is complete, Weiss hypothesizes that one reason that certain rural clinics have not been able to achieve adequate colorectal cancer screening rates may be due to lack of regular access to care.

“Or they access care only for urgent or immediate concerns and are not really doing that yearly preventive exam where there’s time to sit down and talk about the prevention strategies that they can do to help with their health care,” Weiss said.

She added that in many places, regardless of being a rural or urban setting, there’s a difference in how colorectal cancer screening is portrayed and talked about by primary care providers in terms of what tests are available.

“In the United States, we talk a lot about colonoscopy,” said Weiss. “And as a gastroenterologist, I definitely agree colonoscopy is a great colon cancer screening test. But there's also data to show that offering multiple types of screening tests is one way to increase colon cancer screening rates.”

Patients in rural settings may have decreased access to providers who perform colonoscopies due to distance, she explained. However, their providers could explain or offer another reasonable alternative, such as an at-home stool test. This is also a more affordable option than a colonoscopy, which is significant considering that a lack of insurance coverage may be another reason preventing these patients from getting screened.

“I think there's also just issues potentially about this sensitive topic,” said Weiss. “So ideas about talking about a colonoscopy with your provider or with family members may not be felt to be appropriate, or people might have a bit of a stigma about colorectal cancer. Especially if their doctors are really only talking about colonoscopies. So, I think that the discussion needs to be had, I think people really need to talk about their family history. They need to find out who else in their family has had colon cancer, because that increases their potential risk.”

This article was originally published on Cure® as “

New Initiative Explores How to Increase CRC Screening Rates in Rural Areas

Novel research at University of Washington aims to improve the rate of colorectal cancer screenings in rural America. 

New Strategies Aim to Expand Preventative CRC Screenings in Rural America

Patients with relapsed or refractory multiple myeloma (RRMM) reported lower incidences of grade ≥2 cytokine release syndrome (CRS) after receiving anakinra (Kineret) prophylaxis with orvacabtagene autoleucel (orva-cel), a B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy.

The data, which were presented at the European Hematology Association (EHA) 2021 Virtual Congress, also showed that the use of anakinra prophylaxis had no adverse effect on the incidence of neurological events (NEs), infection, macrophage activation syndrome/hemophagocytic lymphohistiocytosis (MAS/HLH), orva-cel expansion or disease response.

Thirty-three patients with RRMM who had previously received at least 3 prior lines of therapy were sequentially enrolled onto the phase 1/2 EVOLVE study (NCT03430011). Anakinra 100 mg was administered subcutaneously the night prior to orva-cel infusion, 3 hours before the infusion on day 1 and every 24 hours on days 2-5. If patients developed CRS, the dosing was increased to every 12 hours.

The median follow-up was 3 months for the anakinra prophylaxis arm (n = 14) and 8.8 months in the non-anakinra prophylaxis arm (n = 19). In the anakinra prophylaxis and non-anakinra prophylaxis arms, the median number of prior regimens was 6 and 5; bridging therapy was used in 57% and 68% of patients, respectively. The total frequency of CRS was similar in the two groups, however there were less grade 2 events in patients receiving anakinra prophylaxis (HR = 0.54; 95% CI, 0.21-1.38). Tocilizumab (Actemra) and corticosteroid use was numerically lower in patients treated with anakinra prophylaxis.

“Most baseline demographics and disease characteristics were similar between groups,” said Luciano J. Costa, MD, Associate Director for Clinical Research, O’Neal Comprehensive Cancer Center at University of Alabama at Birmingham School of Medicine, during a presentation of the findings. “But potentially important differences were noted in measurable serum M-protein, serum free light chain only, extramedullary plasmacytoma and lactate dehydrogenase above the upper limit of normal.”

After a 2-month efficacy assessment, the objective response rate (ORR) was 100% in the anakinra prophylaxis arm and 95% in the non-anakinra prophylaxis arm.

“At month six after orva-cel treatment, 87.5% of anakinra prophylaxis patients and 62% of non-anakinra prophylaxis patients retained detectable CAR transgene copy,” Costa concluded.

The authors noted that these results warrant further study of anakinra prophylaxis in combination with CAR T-cell therapy in these patients.

Costa L, Mailankody S, Shaughnessy P, et al. Anakinra prophylaxis in patients with relapsed/refractory multiple myeloma receiving orvacabtagene autoleucel. Presented at: 2021 European Hematology Association Congress; June 9-17, 2021; Virtual. Abstract EP747.

This article was originally published on OncLive as 

“CAR T-Cell Therapy-Associated Toxicities Could Be Mitigated With Anakinra Prophylaxis in Multiple Myeloma”


Anakinra prophylaxis was associated with lower incidences of ≥2 grade cytokine release syndrome and no adverse effects on the incidence of neurological events in patients with multiple myeloma. 


Anakinra Prophylaxis Produces Lower Toxicities for Patients with Multiple Myeloma

Early results showed that a new care delivery model improved breast cancer care, according to a poster presentation at this year’s Oncology Nursing Society (ONS) Annual Congress.

The 4R Care Sequence® is a one-page, multimodality, personalized care project plan that is used by the care team to plan and deliver care. The 4 Rs in the title represent the right information, care, patient and time. It incorporates recommendations for patient-centric care pathway plans from the Institute of Medicine, Medicare’s OCM and NCCN guidelines, which include multi-modality planning from diagnosis to survivorship that specifies the clinical team, identification of therapy and side-effects and supportive care.

“The 4R model provides a roadmap for the patient and also for the patient’s care team,” said Janeen Bazan, RN, OCN, BSN, lead author of the poster and an oncology nurse navigator from Advocate Sherman Hospital, during the presentation. “It’s very helpful in time management for the patient.”

To understand how the 4R Care Sequence® plans impacted care, researchers surveyed 77 patients with stage 0-3 breast cancer from September 2019 to August 2020 at Advocate Sherman Hospital. Of the patients, 28 received 4R Care Sequences® and 49 received a baseline control model.

A survey given to all patients asked whether or not the patients’ care provider instructed them to do certain activities. The researchers found that all patients who received the 4R Care Sequences® were more likely to have been counseled in 8 areas:

Getting an immunization (flu, pneumonia, shingles) before starting cancer treatment (52% of baseline cohort, 70% of 4R cohort)

Seeing a dentist before starting cancer treatment (13% of baseline cohort, 33% of 4R cohort)

Getting a genetic counseling appointment before surgical decision (39% of baseline cohort, 44% of 4R cohort)

Managing weight if over or under weight (16% of baseline cohort, 26% of 4R cohort)

Getting a nutritionist consult about how to eat during cancer treatment (15% of baseline cohort, 26% of 4R cohort)

Getting emotional support (46% of baseline cohort, 52% of 4R cohort)

Keeping up appointments with primary care for routine care (67% of baseline cohort, 75% of 4R cohort)

Caring for a chronic disease (43% of baseline cohort, 46% of 4R cohort)

Early results showed that the use of the 4R Care Sequences® improved the referrals of recommended breast cancer care. Due to the small sample size, Bazan reported that the results are not statistically significant, however, the trend is still encouraging. The researchers’ plan to continue using 4R Care Sequences, collecting patient surveys and assessing their impact.

“I’m very excited to look at our next data and share with other programs, and hopefully bring in other cancer types,” Bazan said.

Bazan J. Early results: Impact of 4R (Right Info / Care / Patient / Time) care sequence plans, provided to patients by oncology nurses, on timing and sequence of guideline recommended care. Presented at: Oncology Nursing Society 46th Annual Congress; April 20, 22, 27, and 29, 2021. ePoster 1567. 

https://ons.confex.com/ons/2021/qi/eposterview.cgi?eposterid=1567

Early research showed an improvement in provider recommendations of care for patients with breast cancer based on eight guideline metrics.

A New Care Delivery Model May Positively Impact Care Referrals for Patients with Breast Cancer

Although nursing and pharmacy staff responded positively to a new Chemotherapy Education Policy mandating pre-treatment patient education and defining standards for the process, it failed to meet its goals of increasing the quality of that education and decreasing the instances of patients receiving education on the day of their first dose, according to a poster presentation at this year’s Oncology Nursing Society Annual Congress.

The researchers aimed to standardize and increase the quality of the pre-treatment chemotherapy education process and to decrease the amount of patients receiving “same day chemo teaches,” or learning about their treatment on the day of their first dose, to reduce patient anxiety and increase understanding.

“At our National Comprehensive Cancer Network (NCCN)-designated ambulatory oncology center, patients are educated about their treatment by both nurses and pharmacists,” said Martha Read, MSN, RN, OCN, of the Seattle Cancer Care Alliance, during the presentation. “There was a lack of consistency in the educational content covered, the materials that were given to the patient and when the education took place.”

To reach these goals, a chemotherapy education committee comprised of providers, pharmacists, nurses, supportive care and patient education services developed a policy to standardize the education process, with identified benchmarks. These changes defined standards for educational materials and acceptable online resources, educational content (common side effects, treatment schedule, supportive care, when to contact team), documentation and education scheduling of pre-treatment and a 3-day post-treatment follow up call from the clinic nurse.

After implementing the new education policy, the percentage of patients receiving chemotherapy education on the same day as their first day of treatment dropped from 33% to 28%. While the number went down, and nursing and pharmacy staff responded positively to the changes, Read explained, post-intervention, “same day chemo” teaches still happened between 41-48% of the time.

“Our next steps are to identify the barriers to providing pre-treatment chemotherapy education prior to the first day of treatment,” said Read. “And also, to provide additional education to reinforce the standards that were set in our policy.”

The researchers also plan to evaluate the implementation of the three-day follow up call obtaining patient feedback on the education experience.

Read M. Improving Chemotherapy Patient Education through Standardization: Does a Policy Help? Presented at: Oncology Nursing Society 46th Annual Congress; April 20, 22, 27, and 29, 2021. ePoster 1536. https://ons.confex.com/ons/2021/cp/eposterview.cgi?eposterid=1536

While staff at a NCCN-designated oncology center responded positively to a new Chemotherapy Education Policy, its implementation did not increase the quality of education or decrease the incidence of “same day chemo teaches,” according to data presented at the ONS Annual Congress.

Jamie Cesanek

Articles

Cilta-cel CAR T-Cell Therapy May Satisfy Need For Deeper Treatment Responses in Multiple Myeloma

New Strategies Aim to Expand Preventative CRC Screenings in Rural America

Anakinra Prophylaxis Produces Lower Toxicities for Patients with Multiple Myeloma

A New Care Delivery Model May Positively Impact Care Referrals for Patients with Breast Cancer

Chemotherapy Education Policy Fails to Increase Education and Decrease ‘Same Day Chemo’ Teaching