Dr Binod Dhakal Discusses Game-Changing Cilta-Cel Approval for RRMM


Binod Dhakal, MD, associate professor, Medical College of Wisconsin, is lead investigator of the CARTITUDE-4 study, from which data were used by the FDA to approve ciltacabtagene autoleucel (cilta-cel) for patients with relapsed/refractory multiple myeloma (RRMM) who have received at least 1 prior line of therapy.

Binod Dhakal, MD, associate professor, Division of Hematology and Oncology, Medical College of Wisconsin, and lead investigator of the CARTITUDE-4 study, looks back on the recent FDA approval of Janssen/Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel [cilta-cel]) for patients with relapsed/refractory multiple myeloma (RRMM) who have received at least 1 prior line of therapy.

His research focus is MM, especially new treatments—including immunotherapy—and on some subtypes of MM, such as high-risk disease and patients with myeloma kidney disease.


Please tell us about the CARTITUDE-4 study, which investigated cilta-cel in RRMM.

CARTITUDE-4 is actually the first phase 3study that is designed to evaluate the efficacy and safety of CAR [chimeric antigen receptor] T-cell therapy—here, cilta-cel or ciltacabtagene autoleucel—in patients with lenalidomide-refractory multiple myeloma who had received 1 to 3 prior lines of therapy. This is a phase 3 randomized study comparing cilta-cel vs standard of care.

In this, there are 2 standards of care, which are highly effective standard-of-care regimens, that were selected. One is daratumumab, pomalidomide, and dexamethasone, or DPd, and the other one is pomalidomide, bortezomib, and dexamethasone, or PVd. Data from CARTITUDE-4 adds to the body of evidence that cilta-cel offers substantial clinical benefit, as observed in small cohorts of early-line patients in CARTITUDE-2 and in heavily pretreated patients who received cilta-cel in the CARTITUDE-1 study that is a pivotal study that led to the approval of the cilta-cel in late-relapsed patients.

In this study, we also observed lower rates of CAR T–related adverse events like CRS [cytokine release syndrome],ICANS [immune effector cell–associated neurotoxicity syndrome], and other neurocognitive treatment-emergent adverse events than in the CARTITUDE-1 patient population, suggesting cilta-cel may have a better safety profile when use an early lines of treatment.

Can you discuss the significance of the FDA’s approval of cilta-cel for earlier treatment of RRMM?

I think this is quite an important milestone for both the patients and the myeloma physician.Because in CARTITUDE-4, we showed that cilta-cel, or Carvykti, demonstrated significant efficacy, remarkable efficacy as a personalized 1-time infusion in patients with 1to 3prior lines of therapy who were lenolidamide refractory. And with this approval, I'm very excited for patients who have the opportunity for treatment-free interval for multiple myeloma as early as the first relapse, with the hope of eliminating the burden of having to be on continuous treatment with other therapies while living with this challenging disease.

I think it's really remarkable for the patients to have an option, given how significant a benefit it has shown in the CARTITUDE-4 trial.

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