July 4, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Roche's SKYSCRAPER-06 Update, Boehringer's SIRP Treatment, HUTCHMED's NDA

  1. Roche provides update on phase II/III SKYSCRAPER-06 study in metastatic non-squamous non-small cell lung cancer
    • The SKYSCRAPER-06 study evaluating tiragolumab plus Tecentriq and chemotherapy did not meet primary endpoints of progression-free survival and overall survival.
    • The combination showed reduced efficacy compared to the comparator arm, leading to the decision to halt the trial.
    • Safety profile was consistent with previous studies, with no new or unexpected findings.
    • Patients and investigators will be unblinded, and results will be shared with health authorities and presented at an upcoming medical meeting.
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  2. Boehringer Ingelheim and OSE Immunotherapeutics advance clinical development of first-in-class SIRP cancer immunology treatment BI 770371
    • Boehringer Ingelheim and OSE Immunotherapeutics are advancing their SIRPα immuno-oncology program into the next phase of clinical development.
    • The next generation SIRPα inhibitor antibody will be tested in a Phase 1b study.
    • SIRPα is a receptor on macrophages that, when blocked, enhances immune activity against cancer cells.
    • Boehringer Ingelheim will handle all further development and potential future commercialization.
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  3. HUTCHMED announces NDA acceptance in China for tazemetostat for the treatment of relapsed or refractory follicular lymphoma with priority review status
    • The China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for tazemetostat for relapsed or refractory follicular lymphoma (R/R FL) and granted it Priority Review status.
    • Tazemetostat, developed by Epizyme (an Ipsen company), is a first-in-class methyltransferase inhibitor of EZH2, already approved in the U.S. and Japan for certain patients with R/R FL.
    • The NDA is supported by a Phase II bridging study in China and additional clinical studies conducted by Epizyme outside China.
    • HUTCHMED is also leading the SYMPHONY-1 study in China, evaluating tazemetostat in combination with rituximab and lenalidomide for R/R FL patients.
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  4. Apollomics announces updated strategic focus and leadership team changes
    • Apollomics will focus on enrolling NSCLC patients with Met Amplification in the SPARTA Phase 2 clinical trial.
    • Leadership changes include the transition of co-founder Sanjeev Redkar and Chief Medical Officer Peony Yu to consulting roles.
    • Cost reduction measures are expected to extend capital resources into Q3 2025 and reduce ongoing operational expenses by over 50%.
    • Vebreltinib, a selective c-MET inhibitor, is under clinical investigation and has received conditional approval from the NMPA of China.
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  5. Northwest Biotherapeutics announces positive votes at annual meeting; reviews strong progress and growth opportunities
    • Over 77% of all shares were voted at the Annual Shareholders Meeting.
    • All five proposals, including re-election of directors and ratification of stock options, were approved by overwhelming margins.
    • The company reviewed its progress on the Marketing Authorization Application (MAA) in the UK, the Sawston facility, and the Flaskworks system.
    • Northwest Biotherapeutics has completed a 331-patient Phase III trial of DCVax-L for glioblastoma and submitted a MAA for commercial approval in the UK.
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