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Novartis' Kymriah (tisagenlecleucel) Fails to Meet its Primary Endpoint in P-III BELINDA Study as 2L Treatment in Aggressive B-Cell Non-Hodgkin Lymphoma

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Novartis' Kymriah (tisagenlecleucel) Fails to Meet its Primary Endpoint in P-III BELINDA Study as 2L Treatment in Aggressive B-Cell Non-Hodgkin Lymphoma

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  • The P-III BELINDA study evaluates the efficacy- safety- & tolerability of Kymriah vs SOC in patients with aggressive B-cell NHL who had primary refractory disease or relapsed within 12mos. of 1L treatment in 73 sites across 18 countries globally
  • The study did not meet its 1EPs of EFS while the safety profile was consistent with an established safety profile of Kymriah. The therapy demonstrated strong response rates & a remarkable safety profile in r/r FL with an anticipated regulatory filing in H2’21
  • Kymriah is 1st FDA-approved CAR-T cell therapy for r/r ALL in pediatric & adult patients and r/r adult DLBCL. The company continues to accelerate the development of a next-generation platform

 Ref: Novartis | Image: Novartis

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