KRASG12C-Mutant Solid Tumors: Adagrasib Monotherapy

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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