Dr Anderson on the FDA ODAC Decision Regarding Cilta-Cel in R/R Multiple Myeloma

Kenneth C. Anderson, MD, program director, Jerome Lipper Multiple Myeloma Center, LeBow Institute for Myeloma Therapeutics, Dana-Farber Cancer Institute; Kraft Family Professor of Medicine, Harvard Medical School, discusses 

FDA Oncologic Drugs Advisory Committee (ODAC) decision

 regarding the use of ciltacabtagene autoleucel (cilta-cel; Carvykti) in relapsed/refractory multiple myeloma.

 regarding cilta-cel in relapsed/refractory multiple myeloma was its endorsement for use in patients with lenalidomide (Revlimid)–refractory myeloma who had received only 1 prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), Anderson begins. This decision was based on data from the phase 3 CARTITUDE-4 trial (NCT04181827), where cilta-cel demonstrated superior outcomes compared with standard-of-care therapies, he explains. The progression-free survival (PFS) data favored cilta-cel significantly, with a median PFS that was not reached in the cilta-cel arm vs 11.8 months (95% CI, 9.7-13.8) in the standard-of-care arm (HR, 0.26; 95% CI, 0.18-0.38; 

 < .001). The median overall survival (OS) was also not reached in either arm, but at 2 years, the OS rate was notably higher at 79% with cilta-cel vs 66% with standard of care, Anderson reports. These data also supported the April 5, 2024 

 for the treatment of patients with relapsed/refractory disease who have received at least 1 prior line of therapy, including a PI and an IMiD, and are refractory to lenalidomide.

This ODAC decision is exciting as it recommends extending the use of cilta-cel to patients with disease that is relapsed/refractory to only 1 prior treatment, an indication that differs from the agent’s initial approval for heavily pretreated patients who had undergone at least 4 prior therapies, he expands. Notably, only a minority of patients in CARTITUDE-4 had been exposed to CD38 monoclonal antibodies as part of their initial treatment, contrasting with common practice in North America where daratumumab (Darzalez) is frequently used in initial regimens for both transplant-eligible and transplant-ineligible patients, Anderson states.

Despite the promising efficacy results in the trial, there were concerns about early deaths in the cilta-cel arm, he continues. Additionally, secondary cancers emerged as a concern, with similar secondary cancer incidence rates observed between the cilta-cel and standard-of-care arms, according to Anderson. In summary, the ODAC decision highlights the efficacy and endorsement of cilta-cel for use earlier in multiple myeloma disease course, providing a meaningful treatment option for patients with relapsed/refractory disease who have undergone limited prior therapies, he concludes.

Videos

Kenneth C. Anderson, MD, discusses the recent FDA ODAC decision regarding the use of cilta-cel in relapsed/refractory multiple myeloma.

Kenneth C. Anderson, MD, a 2014 Giant of Cancer Care in Myeloma, program director, Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics, institute physician, Dana-Farber Cancer Institute/Brigham and Women's Cancer Center, discusses how currently available agents will continue to impact the field of multiple myeloma.

Not one agent alone will be enough to make an impact on all patients, Anderson explains. This is especially true in events of disease recurrence, when the numbers of mutations significantly increase—and are usually not the same as they were in an initial myeloma case. Therefore, more agents need to be available in order to target various mutations.

Combination regimens will be a likely step for future treatment approaches, he says. PD-1/PD-L1 agents, though not approved in this setting, could have potential in this patient population.

Dr. Anderson on Future Treatment Landscape of Multiple Myeloma

Kenneth C. Anderson, MD, Giant of Cancer Care: Myeloma, Dana-Farber Cancer Institute/Brigham and Women's Cancer Center, discusses how the definition of myeloma has changed. Anderson presented on diagnostic criteria and management of multiple myeloma at the 2016 NCCN Annual Conference.

With 7 new FDA-approved therapies in 2015 for myeloma, Anderson says it was a truly remarkable year. In addition to these new therapies, a changed definition of the disease led to revised NCCN guidelines.

In addition to tradition CRAB features–hypercalcemia, renal dysfunction, anemia and bone lesions–the definition of myeloma now includes other features, according to Anderson. Patients with more than 60% plasma cells, kappa/lambda free light chain ratio greater than 100 or bone lesions on sensitive imaging (MRI or PET CT scan) are all eligible for treatment now. As a result, fewer patients are now classified as having smoldering myeloma.

View more from the 2016 NCCN Annual Conference

Kenneth C. Anderson, MD, Giant of Cancer Care: Myeloma, Dana-Farber Cancer Institute/Brigham and Women's Cancer Center, discusses how the definition of myeloma has changed.

Kenneth C. Anderson, MD

Articles

Dr Anderson on the FDA ODAC Decision Regarding Cilta-Cel in R/R Multiple Myeloma

Dr. Anderson on Future Treatment Landscape of Multiple Myeloma

Dr. Anderson on How the Definition of Myeloma Has Changed