Darovasertib (IDE196) + crizotinib

Development notes

Collab w/ Pfizer. IDE196-002 trials. Q2 2023- Initiated Ph2/3 trial. 11/7/23- Multiple patients dosed. Achieves triple-digit enrollment. 12/17/24- IDMC recommended move-forward dose and completion in Part 2a dose optimization. 2/13/25- Trial ongoing. 8/29/25-Present Ph2 Median OS data at SMR in October 25-28, 2025. 11/04/25:- OptimUM-02 Ph2/3 median PFS data expected YE 2025–Q1 2026; enrollment completion targeted YE 2025, potential accelerated filing. 12/11/25:- Completed full OptimUM-02 enrollment of 435 patients; median PFS topline data expected Q1 2026. 02/17/26:- 130 progression events reached in OptimUM-02; randomized PFS topline results expected around the last week of March 2026. 03/22/26:- OptimUM-02 database lock projected 1H April 2026; topline data analysis expected soon after. 04/13/26:- OptimUM-02 topline positive PFS/ORR. NDA submission targeted H2 2026. Full data at 2026 conference. 04/21/26:- Complete OptimUM-02 data presented at ASCO June 1, 2026. 04/30/26:- FDA agreed to RTOR review. First NDA pre-submission May 2026; NDA filing completion H2 2026. ASCO 2026 late-breaking oral. 05/05/26:- OptimUM-02 met primary PFS endpoint; ASCO 2026 LBA planned June 1; NDA under RTOR targeting completion H2 2026. 06/01/26:- Complete OptimUM-02 primary analysis presented; NDA filing completion expected H2 2026. OS interim analysis update planned. 07/17/26:- OptimUM-02 subgroup analysis to be presented at ESMO Oct 23-27, 2026. 08/04/26:- OptimUM-02 NDA underway; ESMO subgroup data October 2026; OS update Mid-2027.