Release Date: March 20, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: On the LINNET study, what are the gating factors to starting? And then on the B7-H3 [TOP1 ADC] where are you in the dose expansion? A: With regard to LINNET, the standard of care in later line ovarian cancer is quite low, with overall response rates of 10% to 15% with anti-PD-1 in experimental settings. We believe our study will inform further development in these indications. For MGC026, the Phase 1 study has enrolled well, and we expect to select a dose for further expansion later this year.
Q: Can you discuss the rationale behind developing lorigerlimab in ovarian and clear cell gynecologic cancers? And when could we see initial clinical data for MGC026? A: We probably won't show data for MGC026 until the latter half of this year. For lorigerlimab, we target T-cells in the tumor microenvironment co-expressing PD-1 and CTLA-4, sparing peripheral T-regulatory cells, which reduces classic toxicities. This approach is promising in historically insensitive cancers like ovarian cancer.
Q: Given the rPFS data for vobra duo, how does this clarify the path forward for MGC026? And for the LORIKEET data, should we expect rPFS or just ORR? A: For LORIKEET, we will see ORR, but rPFS is event-driven. MGC026 differs from vobra duo with a different linker and payload, potentially offering better activity and fewer toxicities. We haven't decided on specific indications for MGC026 yet.
Q: Are there plans to target LINNET in traditionally hot tumors or combine it with non-IO agents? A: We prioritize studies based on open spaces like ovarian cancer but haven't excluded other tumors. We are open to exploring other indications and combinations, especially if LORIKEET shows positive results. Combining with other ADCs, TKIs, and therapeutics is planned.
Q: Can you provide details on the event rate for LORIKEET and potential data disclosure? A: The study is fully enrolled, and we're waiting for events. It's too early to comment on the event rate, but a PFS event rate in the second half of the year is possible. ORR data could be disclosed even without an rPFS trigger.
Q: What is the highest non-toxic dose for MGC026 in pre-clinical trials, and is it applicable to both candidates? A: We achieved doses of 50 mg/kg in primate studies without hitting a toxic dose, applicable to both MGC026 and MGC028.
Q: Can you provide details on MGD024 Phase 1 progress and Gilead's opt-in points? A: The trial is progressing slowly due to FDA expectations for dose escalation. We are nearing but haven't reached MTD yet. Gilead's opt-in points could be this year.
Q: What are your expectations for discontinuation rates in LORIKEET, and what learnings informed the LINNET program? A: We expect better tolerability with lorigerlimab, leading to lower discontinuation rates. Learnings from LORIKEET and Phase 1 studies, including tolerability and dose selection, informed the LINNET program.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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