Adagrasib

KRYSTAL-1 (NCT03785249) was a phase I/II multiple expansion cohort clinical trial that investigated adagrasib (600 mg orally twice daily) in patients with advanced solid tumors. A phase II cohort of the trial included patients with NSCLC and KRAS G12C variants who were previously treated with platinum-based chemotherapy and anti–programmed death 1 (PD-1) or anti–programmed death-ligand 1 (PD-L1) therapy. The cohort enrolled 116 patients; 98.3% had previously received both chemotherapy and immunotherapy. The primary end point was objective response assessed by blinded independent central review.[58][Level of evidence C3]

KRYSTAL-1 (NCT03785249) was a phase I/II multiple expansion cohort clinical trial that investigated adagrasib (600 mg orally twice daily) in patients with advanced solid tumors. A phase II cohort of the trial included patients with NSCLC and KRAS G12C variants who were previously treated with platinum-based chemotherapy and anti–programmed death 1 (PD-1) or anti–programmed death-ligand 1 (PD-L1) therapy. The cohort enrolled 116 patients; 98.3% had previously received both chemotherapy and immunotherapy. The primary end point was objective response assessed by blinded independent central review.[58][Level of evidence C3]

Among 112 evaluable patients, the confirmed objective response rate was 42.9% (95% CI, 33.5%–52.6%), including one complete response (0.9%). The median DOR was 8.5 months (95% CI, 6.2–13.8). Disease control occurred in 79.5% of patients (95% CI, 70.8%–86.5%).

KRYSTAL-1 (NCT03785249) was a phase I/II multiple expansion cohort clinical trial that investigated adagrasib (600 mg orally twice daily) in patients with advanced solid tumors. A phase II cohort of the trial included patients with NSCLC and KRAS G12C variants who were previously treated with platinum-based chemotherapy and anti–programmed death 1 (PD-1) or anti–programmed death-ligand 1 (PD-L1) therapy. The cohort enrolled 116 patients; 98.3% had previously received both chemotherapy and immunotherapy. The primary end point was objective response assessed by blinded independent central review.[58][Level of evidence C3]

The median PFS was 6.5 months (95% CI, 4.7–8.4), and the median OS was 12.6 months (95% CI, 9.2–19.2).

KRYSTAL-1 (NCT03785249) was a phase I/II multiple expansion cohort clinical trial that investigated adagrasib (600 mg orally twice daily) in patients with advanced solid tumors. A phase II cohort of the trial included patients with NSCLC and KRAS G12C variants who were previously treated with platinum-based chemotherapy and anti–programmed death 1 (PD-1) or anti–programmed death-ligand 1 (PD-L1) therapy. The cohort enrolled 116 patients; 98.3% had previously received both chemotherapy and immunotherapy. The primary end point was objective response assessed by blinded independent central review.[58][Level of evidence C3]

Among 33 patients with previously treated stable CNS metastases, the intracranial confirmed objective response rate was 33.3% (95% CI, 18.0%–51.8%).

KRYSTAL-1 (NCT03785249) was a phase I/II multiple expansion cohort clinical trial that investigated adagrasib (600 mg orally twice daily) in patients with advanced solid tumors. A phase II cohort of the trial included patients with NSCLC and KRAS G12C variants who were previously treated with platinum-based chemotherapy and anti–programmed death 1 (PD-1) or anti–programmed death-ligand 1 (PD-L1) therapy. The cohort enrolled 116 patients; 98.3% had previously received both chemotherapy and immunotherapy. The primary end point was objective response assessed by blinded independent central review.[58][Level of evidence C3]

Grade 3 or higher adverse events occurred in 44.8% of patients and included two deaths. The most common adverse events were diarrhea, nausea, fatigue, vomiting, dyspnea, increased creatinine, increased ALT, increased AST, and decreased appetite. Adverse events led to therapy discontinuation in 6.9% of patients.