(Colorectal Cancer) Is Adagrasib ± Cetuximab Effective? KRYSTAL-1 Phase 1/2 Trial Results

• February 1, 2023
• 1 min read

On December 21, 2022, Rona Yaeger and colleagues from Memorial Sloan Kettering Cancer Center published results in the New England Journal of Medicine from the KRYSTAL-1 Phase 1/2 clinical trial evaluating the efficacy and safety of adagrasib ± cetuximab in previously treated KRAS G12C mutation-positive metastatic colorectal cancer patients.

Trial Design:

The KRYSTAL-1 trial was an open-label, non-randomized study enrolling previously treated KRAS G12C mutation-positive metastatic colorectal cancer patients (N=76), divided into:

• Adagrasib monotherapy group: 600 mg twice daily (N=44)
• Adagrasib 600 mg twice daily + cetuximab 250 mg/m² weekly or 500 mg/m² biweekly (N=32)

Primary endpoints were objective response rate (ORR) and safety.

Results at median follow-up of 20.1 months (monotherapy) and 17.5 months (combination):

Safety:

Grade 3–4 adverse events: Adagrasib alone 34% vs. adagrasib + cetuximab 16%.

Conclusion: Based on the KRYSTAL-1 trial results, Rona Yaeger and colleagues concluded that adagrasib ± cetuximab demonstrated favorable anti-tumor activity in previously treated KRAS G12C-mutant metastatic colorectal cancer patients, with the combination showing a duration of response exceeding 6 months.

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2212419

Colorectal Cancer | KRAS G12C | Adagrasib | Cetuximab

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