Weekly Digest - 22-28 Apr 2023
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - 22-28 Apr 2023
April 23, 2023: Darovasertib (oral) and Crizotinib (oral) / Uveal Melanoma / Ideaya: Positive Phase 2 data and successful FDA Type C meeting on registrational trial design
Ideaya reported positive results from the Phase 2 trial investigating Darovasertib and Crizotinib combination in metastatic uveal melanoma
- ORR of 45%, DCR of 90% and median PFS of ~7 months in 20 patients in 1L MUM
- ORR of 30%, DCR of 87% and median PFS of ~7 months in 63 patients any-Line MUM
- Neoadjuvant PoC: Ocular tumor shrinkage in 100% UM / MUM patients, including a neoadjuvant UM patient with a PR at 1 month and a second neoadjuvant UM patient who was spared enucleation with ~80% tumor shrinkage at 4 months
Based on the FDA meeting, Ideaya will initiate the Phase 2/3 registrational trial in Q2 2023 in 1L HLA-A2 negative MUM, with median PFS as a primary endpoint for potential accelerated approval
- “The observed efficacy in 1L metastatic uveal melanoma patients – including confirmed ORR of 45% and median PFS of ~ 7 months – is clinically significant and represents a potential paradigm shift for treating MUM patients. The interim data for the darovasertib and crizotinib combination treatment in MUM suggests a compelling clinical efficacy and tolerability profile,” said Dr. Meredith McKean, M.D., MPH, Director, Melanoma and Skin Cancer Research at Sarah Cannon Research Institute
