▎WuXiEdited by Kant Content Team

Just now,United StatesFDAApprovalJohnson & Johnson (Johnson & Johnson) and Legend Biotech (Legend Biotech) jointly developed Chimeric Antigen Receptor (CAR）TTherapyCarvykti（ciltacabtagene autoleucel，cilta-cel) for the treatment of relapsed or refractory multiple myeloma (RRMM) adult patients who have previously received at least one proteasome inhibitor (PI) and immunomodulators (IMiD) as a first-line treatment, and lenalidomide (lenalidomide) Drug resistance. According to the press release,CarvyktiIt is the first approved B-cell maturation antigen (BCMA)-targeted therapy for second-line or later treatment in multiple myeloma patients, encompassing CAR-T therapies, bispecific antibodies, and antibody-drug conjugates (ADCs).

This approval is mainly based onCARTITUDE-4Research data, this is an international, randomized, open-label3Phase research, used for evaluationCarvyktiCompared with the standard treatment regimen (SOC) Previously received1-3Lenalidomide-resistant in later-line treatmentRRMMEfficacy and safety in adult patients. In the study,SOCIncluding Pomalidomide, Bortezomib, and Dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd）。

According to the documents related to the ODAC meeting published by the FDA, based on the assessment of the Independent Review Committee (IRC),In the CARTITUDE-4 trial, treatment with Carvykti demonstrated a statistically significant improvement in progression-free survival (PFS) compared to the standard therapy group (HR=0.41, 95% CI: 0.30-0.56, p<0.0001).

▲FDA forPFS Analysis Results of the CARTITUDE-4 Trial (Image Source: Reference [2])

At the time of the second interim analysis, the median overall survival (OS) for the Carvykti group had not yet been reached, while the estimated median OS for the standard treatment group was 26.7 months (HR=0.78, 95% CI: 0.51-1.20).

▲FDA forOS Analysis Results of the CARTITUDE-4 Trial (Image Source: Reference [2])

Last month,The Oncologic Drugs Advisory Committee (ODAC) of the U.S. FDA voted unanimously at 11:0RecommendationCarvykti is used to treat adult patients with relapsed or refractory multiple myeloma.

Carvykti is a CAR-T cell therapy targeting BCMA, which modifies the patient's own T cells using transgenes encoding chimeric antigen receptors to recognize and eliminate cells expressing BCMA.BCMA is primarily expressed on the surface of malignant multiple myeloma B cells, late-stage B cells, and plasma cells. The CAR protein of Carvykti contains two single-domain antibodies targeting BCMA, exhibiting high affinity for cells expressing BCMA. After binding to BCMA-expressing cells, the CAR promotes T-cell activation and expansion, subsequently eliminating the target cells.

In December 2017, Johnson & Johnson and Legend Biotech entered into a global exclusive license and collaboration agreement to develop and commercialize Carvykti. It was approved in February 2022.Approved by the U.S. FDALaunched in China, received conditional marketing authorization from the EU in May, and obtained approval from Japan's MHLW in September for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

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References:

[1] Legend Biotech’s CARVYKTI® (ciltacabtagene autoleucel) Becomes the First and Only BCMA-Targeted CAR-T Cell Therapy Approved by the FDA for Second-Line Treatment of Multiple Myeloma. Retrieved April 6, 2024 from https://www.businesswire.com/news/home/20240405663733/en

[2] FDA Briefing Document. Retrieved March 15, 2024 https://www.fda.gov/media/176986/download

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