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    Dara Azar • Stifel

    Dara Azar's questions to Kura Oncology Inc (KURA) leadership

    Dara Azar's questions to Kura Oncology Inc (KURA) leadership • Q4 2024

    Question

    Dara Azar, on for Brad Canino at Stifel, questioned whether the EMA might have a different view than the FDA on MRD negativity as an endpoint and how the KOMET-017 trial would support global approval. She also asked if the data cut would be consistent between the ASCO presentation and the NDA submission.

    Answer

    CMO Dr. Mollie Leoni clarified that the U.S. accelerated approval would target the MRD endpoint, while survival-based endpoints would support EU approval. She also confirmed that the patient population and data denominator will be the same for the medical meeting presentation and the NDA submission, ensuring consistency.

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    Dara Azar's questions to Summit Therapeutics Inc (SMMT) leadership

    Dara Azar's questions to Summit Therapeutics Inc (SMMT) leadership • Q2 2024

    Question

    Dara Azar inquired about the data disclosure timeline for the HARMONi-2 trial at the World Lung conference, the maturity of the Overall Survival (OS) data, what would be considered a strong Progression-Free Survival (PFS) result, and plans for future Phase III trials.

    Answer

    Executive Dave Gancarz explained the World Lung conference's abstract release process, noting that full details for a late-breaker like HARMONi-2 might be held until the conference. He and Chief Medical Officer Dr. Allen Yang confirmed that OS data is still very immature. Dr. Yang added that the study hitting its interim analysis early speaks to the strength of the PFS data, but declined to comment on specific results. He also suggested that announcements on additional Phase III plans could come at World Lung.

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