Marwan Fakih, MD, presented a new update from the phase 3 CodeBreaK 300 study at the 2024 American Society of Clinical Oncology Annual Meeting, offering insight into the study’s final overall survival (OS) analysis.
While sotorasib plus panitumumab was found to be superior at the study’s primary end point analysis of progression-free survival (PFS), secondary end point data, including OS and objective response rate (ORR) were still immature at the time.
A total of 160 patients were randomized to receive sotorasib 960 mg with panitumumab (n=53), sotorasib 240 mg with panitumumab (n=53), or investigator’s choice of either trifluridine/tipiracil or regorafenib (n=54).
With a median follow-up of 13.6 months as of December 2023, 82 deaths had occurred, with 24, 28, and 30 deaths in the sotorasib 960 mg, sotorasib 240 mg, and investigator’s choice arms, respectively.
The median OS (95% CI) was not reached in the sotorasib 960 mg arm. In the sotorasib 240 mg and investigator’s choice arms, the median OS was 11.9 (7.5 to not estimable) and 10.3 (7.0 to not estimable), respectively. Compared with investigator’s choice, the hazard ratio (95% CI) was 0.70 (0.41-1.18) in the sotorasib 960 mg arm and 0.83 (0.49-1.39) in the sotorasib 240 mg arm.
The ORRs (95% CI) for the sotorasib 960 mg, sotorasib 240 mg, and investigator’s choice arms were 30.2 (18.3-44.3), 7.5 (2.1-18.2), and 1.9 (0.0-9.9), respectively. No new safety signals were observed.
Results of CodeBreaK 300 found a trend toward improved OS for patients who received sotorasib 960 mg with panitumumab. In combination with the treatment’s PFS and response rates, the trial supports the use of sotorasib 960 mg with panitumumab as a potential standard of care for patients with chemorefractory KRAS G12C-mutated mCRC.
© 2025 Mashup Media, LLC, a Formedics Property. All Rights Reserved.