CAR-T Digest- August 2020

CAR-T Digest- August 2020

Novartis announced that Kymriah has met primary endpoint in its pivotal Phase 2 ELARA study in follicular lymphoma

04 Aug 2020

Kymriah (Tisagenlecleucel; CD19 targeting autologous T cell immunotherapy) – Novartis

  • Phase 2 ELARA trial of Kymriah (tisagenlecleucel) in patients with R/R follicular lymphoma (FL) – positive results
  • At an interim analysis (N=97), trial met its primary endpoint of complete response rate (CRR). Detailed results will be presented at ASH 2020
  • No new Kymriah safety signals (Usual CAR-T side effects like cytokine release syndrome (CRS), neurological toxicities present)
  • US filing anticipated in 2021, followed by EU filing

Novartis’ Kymriah hits primary endpoint in pivotal follicular lymphoma trial

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CI Scientists Remarks: 

  • Kymriah is the first FDA-approved CD19 targeting CAR-T cell therapy. It is approved for the treatment of R/R acute lymphoblastic leukemia (ALL) (pediatric and young adult (till 25 years of age), and R/R adult diffuse large B-cell lymphoma (DLBCL) globally
  • Novartis is exploring Kymriah in combination with targeted therapies in approved indications and across all lines in hematological malignancies
  • In Apr’20, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah in R/R FL, based on preliminary results granting an expedited review
  • Per Novartis (SEC filing 2019), sales of Kymriah were constrained by production capacity. Novartis has been optimizing their manufacturing process and has increased Kymriah’s production capacity by 125% since Q1’19. They have added multiple manufacturing facilities globally (France, Netherlands, Japan etc.) in 2019
  • In H1’20, Kymriah sales increased by 106% to $211 million vs H1’19
  • Approval for FL and DLBCL 1st relapse patients (planned filing in 2021) will add to the top line sales

– Dr. Kowndinya, CI Scientists

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