CARTITUDE-4 Extends Survival in Refractory Myeloma

Binod Dhakal, MD, associate professor, division of hematology and oncology, Medical College of Wisconsin and lead investigator of the CARTITUDE-4 study, attended the 21st International Myeloma Society (IMS) Annual Meeting in Rio de Janeiro, Brazil, between September 25 to 28.

Dhakal discussed the methods utilized in the CARTITUDE-4 study and the outcomes it had on patients with relapsed or refractory multiple myeloma. The study compared ciltacabtagene autoleucel (cilta-cel) with standard of care in patients with refractory multiple myeloma.

This transcript has been lightly edited for clarity.

Transcript

What are the latest data on CARTITUDE-4 being presented at IMS this year?

As you know, the CARTITUDE-4 is a phase three randomized study comparing cell to cell vs standard of care in patients with one to three prior lines of therapy and were [lenalidomide] refractory. In the initial presentation of the primary analysis, we sold that CARTITUDE-4 cilta-cel [ciltacabtagene autoleucel] has significant benefit in the progressively survival compared to standard of care with the hazard ratio of 0.26.

That was about a 15.9 month follow up. At the IMS meeting, we are presenting a median follow up of 33.6 months. The previous specified analysis of overall survival was considered along with the updated overall survival, efficacy, and safety outcomes, with the cilta-cel or with the standard of care.

There were 419 patients randomized, 282 cilta-cel and 211 to standard of care, which is one of the either daratumumab, pomalidomide, and dexamethasone (DPd) or pomalidomide, bortezomib, and dexamethsaone (PVd).

At a median fall of 33.6 months, we saw that the median overall survival was not reached in either arm with the cilta-cel and standard of care. An overall survival significantly improved with standard of care, with the hazard ratio 0.55 and significant P value. The 30 month overall survival rates were 76% in the cilta-cell arm vs 64% in the standard-of-care arm.

Overall survival benefited all subgroups in the cilta-cel arm compared with standard of care. In terms of immediate progression free survival, it was still not reached at that follow-up with cilta-cel vs it was 11.8 months in the standard of care, and the hazard ratio is 0.29.

In terms of safety that was consistent with previous interim analysis, there were deaths occurring among 50 patients in the cilta-cel arm and 82 patients in the standard of care arm with 21 patients and 51 respectively, who died of progressive disease.

This study is the first study in myeloma that sold a survival benefit with the BMCA CAR [chimeric antigen receptor] T, in this case using cilta-cel and significantly reduced the risk of death by about 45% of those patients who received a cilta-cel in as early as first relapse.