(Colorectal Cancer) Is Adagrasib ± Cetuximab Effective? KRYSTAL-1 Phase 1/2 Trial Results
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- 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):
| Endpoint | Adagrasib alone | Adagrasib + Cetuximab |
|---|---|---|
| ORR | 19% | 46% |
| Median duration of response | 4.3 months | 7.6 months |
| Median PFS | 5.6 months | 6.9 months |
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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