Johnson & Johnson Innovative Medicine – formerly known as Janssen – has shared positive data for CARVYKTI, its multiple myeloma (MM) drug known generically as cilta-cel, in a subgroup analysis from its Phase III CARTITUDE-4 study.
Data on a subgroup of patients in the study who had an early relapse after initial MM therapy indicated a 73% reduction in risk of disease progression or death with the administration of cilta-cel.
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The company shared its findings at the 2024 American Society of Clinical Oncology’s (ASCO) Annual Meeting, which commenced on 31 May and ends today.
CARTITUDE-4’s chief aim is to evaluate the efficacy and safety of cilta-cel versus standard treatment of pomalidomide, bortezomib and dexamethasone (PVd); or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory MM. The study met its primary endpoint to improve progression-free survival in January 2023.
The subgroup analysis included one of 136 patients who received one prior line of therapy (LOT), including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and were lenalidomide-refractory. After a median follow-up of 16 months, the median progression-free survival (PFS) rate was not reached among patients who received cilta-cel.
Data from an additional subgroup of 79 patients with functional high risk (FHR) multiple myeloma, the 40 treated with cilta-cel had deeper overall response rates – 88% versus 80%, complete response (CR) or better – 68% versus 39%, minimal residual disease (MRD) negativity – 65% versus 10% – and longer median duration of response (mDOR) compared to those treated with standard therapies.
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By GlobalData“This subset analysis of CARTITUDE-4 provides strong evidence that these patients greatly benefit from cilta-cel and will help healthcare professionals better understand the potential of this therapy,” said Luciano Costa, professor of medicine and director of the Multiple Myeloma Program, University of Alabama at Birmingham, and the study’s principal investigator.
Jordan Schecter, VP, disease area leader, multiple myeloma at Johnson & Johnson Innovative Medicine commented: “Many patients with FHR multiple myeloma from the CARTITUDE-4 subgroup analysis experienced deep and durable responses following the single infusion of cilta-cel, further supporting the potential to treat a broader patient population.”
The Oncologic Drugs Advisory Committee (ODAC) for the US Food and Drug Administration recently voted in favour of supporting the use of minimal residual disease as a surrogate endpoint to enable accelerated approvals of new therapies in MM.
