Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: How are you thinking about the potential of using MRD negativity as part of the frontline endpoints? Is there any difference in the methodology used by you versus your peers? A: The base case scenario for frontline studies is using survival as the endpoint. There may be an opportunity to use MRD negativity as a surrogate endpoint in an accelerated design, but it's not yet approved by health authorities. We plan to discuss this with them soon. Regarding methodology, we plan to do a central analysis of samples to provide a uniform result on MRD negativity, as local tests can vary.
Q: For the 600 mg data that you'll present at ASH, what types of data might we see? A: We anticipate showing data on more than 100 patients, updating on their status with respect to response and duration of clinical benefit. We expect consistent activity across dose levels, with improved safety and tolerability at higher doses, which supports moving forward with the 600 mg dose in expansion cohorts.
Q: As we're starting to see longer-term data for ziftomenib and other menin inhibitors, how has that impacted your thinking on the opportunity for the class? A: The emerging data in the frontline setting is promising, with many patients remaining on therapy for extended periods. This suggests a significant opportunity to intercept patients early in their treatment journey, potentially keeping them on therapy for a year or more, which could significantly impact the disease and drive the commercial case.
Q: Regarding the combination updates at ASH, what should we be thinking in terms of benchmarking a win? Is safety still the focus? A: In the relapsed/refractory setting, safety and tolerability are the primary focus, with the ability to safely escalate doses being a strong sign of activity. In the frontline setting, we're comparing against the Vyxeos control arm, with a composite response rate of about 60% and overall survival of about 6 months. We're encouraged by the ability to escalate doses and the duration patients remain on therapy.
Q: What are your current thoughts on employing a strategy similar to a peer company using a European cooperative group for a frontline trial? A: Cooperative groups play an important role, especially for smaller indications. However, for major opportunities like 7+3 and ven/aza, we prefer company-sponsored studies to maintain control over design, timelines, and data interpretation. We will continue to use cooperative groups where appropriate for smaller indications.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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