IDYA - IDEAYA jumps 25% after update on lead program
2023-04-24 13:50:08 ET
IDEAYA Biosciences ( NASDAQ: IDYA ) climbed ~25% Monday marking the biggest intraday gain since September after announcing plans to begin a Phase 2/3 registrational trial in Q2 2023 for its lead program for experimental cancer therapies darovasertib and crizotinib.
The update follows a Type C Meeting between IDEAYA ( IDYA ) and the FDA regarding a trial design to study the combo as a first-line option for HLA-A2 negative metastatic uveal melanoma (MUM).
Simultaneously, the company announced interim data for darovasertib and crizotinib from a Phase 2 trial as of September 22, 2022, in MUM.
Based on twenty first-line and sixty-three evaluable any-line patients, the readout indicates 90% and 87% of Disease Control Rates (DCR) for the combo as a first-line and any-line option in MUM, respectively.
On the safety front, while darovasertib and crizotinib indicated a manageable adverse event profile with mostly Grade 1 or 2 drug-related adverse events ((AEs)), four (6%) patients discontinued the treatment due to a drug-related adverse event, and one experienced a Grade 5 AE.
Read more on IDYA’s updates in MUM
Ideaya says uveal melanoma candidate shrank tumor in 89% of patients
IDEAYA wins FDA fast track status for melanoma treatment
For further details see:
IDEAYA jumps 25% after update on lead program