- Of the 12 Phase 1b patients evaluable for efficacy as of the ASCO-GI data cut-off date (November 1, 2020), 5 (42%) achieved a partial response (PR) and 8 (67%) have shown a durable response ranging from 6.1 to 13.7 months
- Since the ASCO-GI data cut-off date, 2 additional Phase 1b patients have had their initial 8-week scan showing stable disease (SD) and both remain on treatment to-date
- Time to achieving a PR ranges from 2 to 6 months in patients on treatment
- The recommended Phase 2 dose (RP2D) of onvansertib has been established at 15mg/m2 and the Phase 2 segment of the ongoing trial is open to full enrollment of 26 patients across 6 sites in the U.S.
- In the Expanded Access Program (EAP), 6 (66%) of the initial 9 patients treated have shown tumor shrinkage and remain on treatment to-date with durable responses lasting an average of 6 months; 5 different KRAS mutation subtypes are represented (G12A, G12C, G12V, G13D, A146T); all patients had received prior treatment with FOLFIRI
- Decreases in the KRAS mutational burden in patients after the first cycle of treatment have been predictive of subsequent tumor shrinkage in both the clinical trial and EAP
PR Newswire
SAN DIEGO, Jan. 15, 2021
