Amgen Announces Positive Phase III CodeBreaK 300 Results for Sotorasib Combined with Panitumumab in KRAS G12C-Mutated Metastatic Colorectal Cancer

Oct 23, 2023 07:38 CST Updated 07:38

Amgen

Developer of Treatment Drugs for Serious Diseases

On October 22, Amgen announced the global Phase III CodeBreaK 300 study data for Lumakras (sotorasib, 960mg/240mg) in combination with Vectibix (panitumumab) for the treatment of chemotherapy-refractory KRAS G12C-mutated metastatic colorectal cancer (mCRC).Compared with the investigator's choice of drug (trifluridine+tipiracil, or regorafenib), both dose groups of sotorasib + panitumumab demonstrated a statistically significant advantage in progression-free survival (PFS).

CodeBreaK 300 is a randomized, open-label global multicenter Phase III study designed to evaluate the efficacy and safety of sotorasib in combination with panitumumab compared to investigator’s choice of treatment in chemotherapy-refractory KRAS G12C-mutated mCRC patients. The study enrolled 160 participants, who were randomly assigned in a 1:1:1 ratio to receive either sotorasib (960mg) + panitumumab, sotorasib (240mg) + panitumumab, trifluridine + tipiracil, or regorafenib. The primary endpoint is PFS, with secondary endpoints including overall survival (OS) and objective response rate (ORR), among others.

The results showed that, with a median follow-up of 7.8 months, the median PFS was 5.6 months (HR=0.49) for the sotorasib (960mg) + panitumumab group and 3.9 months (HR=0.58) for the sotorasib (240mg) + panitumumab group. The median PFS for subjects receiving the study’s selected therapy was 2.2 months. Regarding secondary endpoints, both dose groups also demonstrated clinically meaningful benefits in ORR, disease control rate (DCR), and duration of response (DOR). Overall survival (OS) data are not yet mature.

In terms of safety, the most common ≥3 grade treatment-related adverse events (TRAEs) in the sotorasib + panitumumab treatment group were acne-like dermatitis,Hypomagnesemia,Rash and diarrhea occurred, but no fatal adverse events were reported.

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