Release Date: October 31, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you walk us through the historical aza controls and how should we interpret the AML results in terms of their relevance to higher-risk MDS? A: The aza-label has a complete remission rate of 17%, which is a regulatory benchmark. Recent trials show variations, with some reporting CR rates in the low 20% range. The AML experiment aimed to leverage the apoptotic mechanism of tamibarotene and aza with venetoclax. The MDS trial is different, testing tamibarotene and aza without venetoclax. The AML results don't predict MDS outcomes, but they show high responses and good safety, important for elderly MDS patients.
Q: What will you be able to disclose in the upcoming data release? A: We will report the primary endpoint outcome of the CR rate in mid-November, evaluated in the first 190 enrolled patients. We will also provide data on the duration and time to complete response, overall response rate, and safety data. However, overall survival data will not be available at that time.
Q: What steps are needed post-data release for the FDA filing, and will a pre-NDA meeting be required? A: We will ensure all data is thoroughly corroborated and validated. Routine regulatory interactions will follow, but nothing unusual is required. We aim to submit the NDA efficiently and straightforwardly.
Q: Can you discuss the commercial preparations for tamibarotene's potential launch in MDS? A: We have been preparing for the launch for over a year, focusing on market awareness, field force sizing, infrastructure, brand planning, manufacturing, and diagnostics to ensure broad access and availability.
Q: Are there plans for a detailed presentation of the recent AML results, and any future plans for 5609? A: The complete AML data was presented at the SOHO meeting. Regarding 5609, it has high potential as a best-in-class CDK7, and we are seeking business development opportunities with larger pharma companies to fully exploit its potential.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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