KRASG12C-Mutant Solid Tumors: Adagrasib Monotherapy
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KRYSTAL-1 Phase II Trial Results
- May 15, 2023
On April 26, 2023, researchers from Mayo Clinic led by Tanios S. Bekaii-Saab published KRYSTAL-1 Phase II trial results in the Journal of Clinical Oncology, evaluating adagrasib in previously treated KRASG12C-mutant solid tumors.
Trial Design
Patient Population: Previously treated KRASG12C-mutant solid tumors (n=63), excluding NSCLC and colorectal cancer (already established benefit)
Treatment: Adagrasib 600 mg twice daily monotherapy
Primary Endpoint: Objective response rate
Median Follow-up: 16.8 months
Key Efficacy Results
Objective Response Rate: 35.1% (n=20 patients, all partial responses)
Response by Tumor Type:
- Pancreatic cancer: 33.3%
- Cholangiocarcinoma: 41.7%
Median Time to Response: 5.3 months
Median Progression-Free Survival: 7.4 months
Safety Profile
Overall adverse events: 96.8% incidence. Grade 3-4 toxicities: 27.0%. No grade 5 toxicities or treatment discontinuations due to adverse events.
Clinical Conclusions
Adagrasib monotherapy demonstrates clinical anti-tumor activity in previously treated KRASG12C-mutant solid tumors, including rare cancer types such as pancreatic and cholangiocarcinoma.
Data Source
https://ascopubs.org/doi/10.1200/JCO.23.00434
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