Dr. Shah on Updated Efficacy of JNJ-4528 in Relapsed/Refractory Myeloma


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Nina Shah, MD, discusses the updated efficacy findings of JNJ-4528 from the phase 1b/2 CARTITUDE-1 study in relapsed/refractory multiple myeloma.

Nina Shah, MD, a hematologist and associate professor of medicine, Department of Medicine, at the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, discussesthe updated efficacy findings of JNJ-4528 from the phase 1b/2 CARTITUDE-1 study in relapsed/refractory multiple myeloma.

An important product that is getting a lot of attention is JNJ-4528, which was examined in the CARTITUDE-1 study, says Shah. JNJ-4528 is a BCMA-targeting CAR T-cell product that differs from idecabtagene vicleucel (ide-cel; bb2121), which also targets BCMA. The former targets 2 aspects of the BCMA protein; as such, it potentially changes some kinetics and how it interacts with the target myeloma cell.

The original data with JNJ-4528 in a small cohort of 29 patients who received treatment were presented at the 2019 ASH Annual Meeting and an impressive ORR of 100% was reported, according to Shah. Similar efficacy had been seen in the preliminary and mature data from the Chinese study with the same product, adds Shah. The CARTITUDE-1 study enrolled an American patient population and, similar to the ide-cel study, patients also had to have received 3 prior lines of therapy or at least have had prior exposure to a proteasome inhibitor, an immunomodulatory agent, or an anti-CD38 antibody. As such, the studies have very similar patient characteristics, notes Shah.

During the 2020 ASCO Virtual Scientific Program, additional data from CARTITUDE-1 were presented and showed that the ORR was still 100% and 86% of patients had a complete response (CR) or stringent CR, which is impressive in such an advanced, heavily pretreated patient population, says Shah. Investigators did not have evaluable data for progression-free survival yet; however, 86% of patients were progression free at 9 months, which is possibly superior to what was seen at the 12-month mark with ide-cel, notes Shah. While not condoning comparing the 2 trials, that is a reason why these data are so anticipated, concludes Shah.

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