Legend Biotech/Janssen Announces FDA Approval of Carvykti for Second-Line Treatment of Relapsed or Refractory Multiple Myeloma

Apr 07, 2024 07:46 CST Updated 07:46

Legend Biotech

Tumor Cell Immunotherapy Developer

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

On April 5, Legend Biotech/Johnson & Johnson jointly announced that the U.S. FDA had approvedCarvykti(Ciltacabtagene autoleucel, cilta-cel) is used to treat patients with relapsed or refractory multiple myeloma (R/R MM) who have previously received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are lenalidomide-resistant.CarvyktiIt is the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for second-line treatment of multiple myeloma patients, including CAR-T therapy, bispecific antibodies, and antibody-drug conjugates (ADC).

The FDA approval is based on the positive results of the CARTITUDE-4 study, whichEvaluationCarvyktiWith pomalidomide, bortezomib andDexamethasone(PVd) or Daratumumab, Pomalidomide, and Dexamethasone (DPd) Comparison of efficacy and safety in patients with relapsed multiple myeloma who are lenalidomide-resistant after having received 1-3 prior lines of therapy.Previously received 1-3 lines of treatment and lenalidomideAmine-refractoryR/R MMPatients were randomly assigned to receive cilta-cel (n=208) orDoctor's Choice Plan (n=211)）。

The results showed,Cilta-cel Group mPFS Significantly Improved(NR vs 11.8 months, HR=0.41, 95%CI 0.30-0.56, p<0.0001), reaching the primary endpoint; the key secondary endpoint ORR also showed benefit (85% vs 68%, p<0.0001), but the FDA noted a higher proportion of PFS events due to death in the cilta-cel group (8% vs 2%).

Currently, the interim OS data are not yet mature (34% information fraction), with median OS not reached in one group and 26.7 months in the other (HR 0.78, 95% CI 0.51-1.20).The OS Kaplan-Meier curves of the two groups crossed at ~11 months., that is, in the previous 11 months, the cilta-cel group had a lower OS. In terms of safety, cilta-cel was generally consistent with previously reported results.

March this yearOn the 15th,FDA ODAC (Oncologic Drugs Advisory Committee) Meeting Expert PanelIn11 votes in favor，0Vote AgainstThe result, it is considered thatCarvyktiUsed in patients who have received at least 1 prior line of therapy (includingPIAndIMiDAnd lenalidomide refractory)R/R MMAdults sufferPatientWith AdvantageThe benefit-risk outcome.

Dr. Ying Huang, CEO of Legend Biotech, stated: "The expansion of Carvykti's indications has the potential to transform the treatment landscape for multiple myeloma, providing doctors and patients with a personalized immunotherapy option that can be used in earlier treatment regimens. Multiple myeloma is an incurable and progressive blood cancer that leads to relapse and drug resistance in patients, creating an urgent need for innovative treatment options. We are committed to improving the quality of life for patients with blood cancers and continuously striving to develop cell therapies that offer hope of a cure."

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