Release Date: April 30, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q & A Highlights
Q: Can you elaborate on your earlier comments regarding the positive outcome with regards to MSN patent litigation and the search for later-stage assets in GU and GI oncology?
A: Michael M. Morrissey, CEO, President & Director of Exelixis, explained that the focus on later-stage assets is not new and aligns with the company's restructuring efforts. These assets are either in or entering pivotal trials, and the company is also looking for collaborations similar to previous cabozantinib checkpoint combination endeavors. Morrissey emphasized the company's capability to add value to late-stage assets and remained open about the size and specific targets of potential deals.
Q: How do you envision the commercial ramp-up for new indications like neuroendocrine tumors (NET), given the established presence of oral TKIs?
A: Patrick J. Haley, EVP of Commercial at Exelixis, expressed confidence in the uptake of new indications, noting that oncologists are already familiar with TKIs in this setting. He highlighted the broad population studied in the CABINET trial, which should make cabozantinib user-friendly and widely applicable across various subtypes of NET, enhancing its market adoption.
Q: Can you discuss the enrollment criteria for STELLAR-305 in comparison to other studies like KEYNOTE-048 or LEAP-010, and the potential need for adjustments based on recent data?
A: Amy C. Peterson, Chief Medical Officer, noted the need to understand the dosing and outcomes from other studies to potentially adjust STELLAR-305. She highlighted the unique mechanisms of zanzalintinib, which could lead to different outcomes compared to other therapies, emphasizing ongoing evaluations to optimize study design based on emerging data.
Q: What are the potential development paths for zanzalintinib in neuroendocrine tumors, and could it include combinations with therapies like Lutathera?
A: Michael M. Morrissey mentioned that neuroendocrine tumors are a high priority for zanzalintinib development, with ongoing assessments of strategic development paths, including possible combinations. The company is excited about the potential in this space, drawing parallels to the development trajectory previously seen with RCC.
Q: How does Exelixis plan to handle the commercial overlap and potential incremental costs for launching in prostate cancer and neuroendocrine tumors?
A: Patrick J. Haley explained that there is significant overlap in the call points between RCC and potential new indications, which allows leveraging existing commercial infrastructure. This overlap should minimize the incremental costs associated with launching cabozantinib for prostate cancer and neuroendocrine tumors.
Q: What factors are influencing the timing of regulatory filings for prostate and neuroendocrine tumors, and are these filings planned for the U.S. only?
A: Amy C. Peterson stated that the completion of data analysis, particularly from BIRC for CABINET and final OS data for CONTACT, are key factors influencing the timing of filings. She confirmed ongoing discussions with regulatory agencies and highlighted the focus on U.S. filings, with partners responsible for submissions in other regions.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.