August 5, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Adaptimmune's FDA Approval, Gene Therapy for Synovial Sarcoma, Galapagos Trial Pause

1. Adaptimmune gets FDA accelerated approval for T cell receptor cell therapy in rare soft tissue cancer

   • The FDA granted accelerated approval for Adaptimmune's cell therapy for synovial sarcoma.
   • Synovial sarcoma is a rare type of cancer typically found in soft tissues.
   • The approval was based on clinical trial data demonstrating significant efficacy.
   • Next steps include further studies to confirm clinical benefits and potential expansion to other indications.
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2. FDA approves first gene therapy to treat adults with metastatic synovial sarcoma

   • The FDA approved Tecelra (afamitresgene autoleucel) for adults with unresectable or metastatic synovial sarcoma.
   • Tecelra is the first FDA-approved T cell receptor (TCR) gene therapy, targeting the MAGE-A4 antigen.
   • Approval was granted under the Accelerated Approval pathway, with a confirmatory trial ongoing.
   • Common adverse reactions include nausea, fatigue, infections, and cytokine release syndrome (CRS).
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3. Actinium provides regulatory update on planned BLA filing and future plans for Iomab-B in the U.S.

   • FDA determined that the Phase 3 SIERRA trial is not adequate to support a BLA filing for Iomab-B.
   • An additional head-to-head randomized clinical trial demonstrating overall survival benefit with Iomab-B is required by the FDA.
   • Actinium will request a meeting with the FDA to discuss specifics of the additional trial.
   • Actinium plans to seek a strategic partner for Iomab-B in the U.S. following completion of FDA interactions.
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4. Galapagos pauses blood cancer CAR-T therapy trial due to one Parkinsonism event

   • Galapagos has temporarily halted patient enrollment in an early-phase trial for multiple myeloma.
   • The pause follows the occurrence of a neurological issue, specifically a Parkinsonism event.
   • The trial is focused on CAR-T therapy for blood cancer.
   • Next steps include investigating the cause of the event and determining the safety of continuing the trial.
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5. Genmab takes full control of acasunlimab development program

   • Genmab will assume sole responsibility for the development and potential commercialization of acasunlimab.
   • BioNTech has opted out of further development under the existing collaboration agreement.
   • Genmab plans to initiate a Phase 3 study in the second half of this year.
   • The collaboration between Genmab and BioNTech on other programs remains unchanged.
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