Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you clarify if the focus for your pivotal trial remains on first-line BRAF mutated melanoma, and what are the patient enrollment criteria? A: We initially identified BRAF mutated melanoma patients as a focus due to their unique benefit from CTLA-4 blockade. However, we have expanded our focus to include all first-line unresectable and metastatic melanoma patients. Our data shows tumor reductions in all eight patients treated, including those with BRAF mutations, supporting a broader patient population for the pivotal trial.
Q: How will you deploy your cash position as you move two programs into pivotal studies? A: We plan to take one program forward ourselves and partner with another. We have sufficient capital to finalize dose optimization under Project Optimist, particularly for CTLA-4, and to keep all activities moving efficiently.
Q: Regarding the feedback for the Roar Two and CTLA-4 programs, what are the investigator treatment options and potential study start times? A: For Roar Two, the investigator treatment options include cetuximab, docetaxel, or methotrexate. We anticipate starting both programs in 2025, with Roar Two ahead of CTLA-4. We are refining the timing as we progress.
Q: In the Roar Two frontline study, what is the total patient number needed, and how does it compare to previous trials like CheckMate 067? A: We anticipate about 570 patients for the full approval endpoint of overall survival, with a smaller earlier look for accelerated approval based on response rate. This is smaller than the CheckMate 067 trial, which had 945 patients across three arms.
Q: For the RR Two program, will the limited randomized evaluation for dosing schedules be integrated into the pivotal study? A: The FDA wants to see results from the limited randomized evaluation of dosing schedules. We see this as part of the phase three trial, but we need formal agreement from the agency on the dose once we present the data.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.