Kymriah CAR-T cell therapy demonstrates remarkable efficacy in treating relapsed or refractory follicular lymphoma

Kymriah CAR-T cell therapy demonstrates remarkable efficacy in treating relapsed or refractory follicular lymphoma

On December 12, 2021, at the 63rd American Society of Hematology (ASH) Annual Meeting, Novartis presented subgroup analysis data from the Phase 2 ELARA study with a median follow-up of 17 months. The results showed that in patients with high-risk relapsed or refractory follicular lymphoma (r/r FL), the CD19 CAR-T cell therapy Kymriah (tisagenlecleucel) demonstrated remarkable efficacy. The one-year progression-free survival (PFS) rate was 67%; for patients who achieved complete remission (CR), the one-year PFS rate reached 86%. Consistent with the initial analysis, Kymriah exhibited significant safety, with no high-grade cytokine release syndrome (CRS) reported within 8 weeks of infusion, and no new safety signals were identified.

Kymriah is the world’s first FDA-approved CAR-T cell therapy, with two approved indications:

(1) Treatment of relapsed or refractory acute lymphoblastic leukemia (r/r ALL) in pediatric and young adult patients (up to 25 years old);

(2) Treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) in adult patients.

Currently, in the United States and the European Union, Kymriah’s supplemental Biologics License Application (sBLA) and Type II variation are under review for the treatment of adult patients with r/r FL who have received at least two prior therapies. In the US, the FDA has granted Priority Review for the sBLA. Previously, the FDA granted Kymriah Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of r/r FL, and the European Commission (EC) granted Kymriah Orphan Drug Designation (ODD) for the treatment of FL. If approved, Kymriah will provide an important treatment option for patients with r/r FL, and r/r FL will become Kymriah’s third B-cell malignancy indication.

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