Amgen colorectal cancer therapy gets USFDA nod

The major efficacy outcome measure was progression-free survival (PFS) as evaluated by blinded independent central review according to RECIST v1.1. Additional efficacy outcome measures included overall survival (OS), overall response rate (ORR), and duration of response (DOR). The study was not statistically powered for OS. Median PFS was 5.6 months (95% CI: 4.2, 6.3) in the sotorasib 960 mg/panitumumab arm and 2 months (95% CI: 1.9, 3.9) in the SOC arm (hazard ratio 0.48 [95% CI: 0.3, 0.78] 2-sided p-value 0.005). The final analysis of OS was not statistically significant. ORR was 26% (95% CI: 15, 40) in the sotorasib 960 mg/panitumumab arm and 0 (95% CI: 0, 7) in the SOC arm. Median DOR was 4.4 months (range: 1.9+, 6+) in the sotorasib 960 mg/panitumumab arm.

The final analysis of PFS for patients randomized to the sotorasib 240 mg/panitumumab arm compared to the SOC arm was not statistically significant.

The recommended sotorasib dose is 960 mg orally once daily. The recommended panitumumab dose is 6 mg/kg administered as an IV infusion every 14 days until disease progression, unacceptable toxicity, or until sotorasib is withheld or discontinued. Administer the first dose of sotorasib before the first panitumumab infusion.

This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.