In a phase I study, the KRAS G12C inhibitor sotorasib was safe and effective for patients with tumors harboring the KRAS G12C mutation.
KRAS G12C mutations are associated with poor outcomes in patients with cancer, and they can occur in about 13% of non–small-cell lung cancers (NSCLCs) and 1% to 3% of colorectal cancers (CRCs) and other solid cancers.
Now, investigators have conducted an industry-funded, phase I study to evaluate the safety and activity of sotorasib, an oral KRAS G12C inhibitor, in 129 pretreated patients with advanced solid tumors (59 with NSCLC, 42 with CRC, and 28 with other tumors) harboring the KRAS G12C mutation.
Results were as follows:
No dose-limiting toxicities or treatment-related deaths were reported.
12% of patients experienced grade 3–4 treatment-related toxicities, the most common of which were diarrhea (30%), fatigue (23%), and nausea (21%).
In t…
Reviewing Author
DisclosuresConsultant/Advisory BoardGenentech; AstraZeneca; Boehringer-Ingelheim; Bristol-Myers Squibb; Clinical Care Options; Heron; Takeda; Ariad; MedIQ; Targeted Healthcare Communications; Novartis; OncLive; Roche; TRM Oncology
RoyaltiesUpToDate
Grant/Research SupportMedimmune; NIH/National Cancer Institute; Millennium; Genentech; Polaris Pharmaceuticals; Seattle Genetics; Boehringer-Ingelheim Pharmaceuticals; SWOG–Hope Foundation; American Cancer Society; Department of Defense; GlaxoSmithKline Pharmaceuticals; Merck; Eli Lilly; Takeda; Bristol-Myers Squibb
DisclosuresConsultant/Advisory BoardGenentech; AstraZeneca; Boehringer-Ingelheim; Bristol-Myers Squibb; Clinical Care Options; Heron; Takeda; Ariad; MedIQ; Targeted Healthcare Communications; Novartis; OncLive; Roche; TRM Oncology
RoyaltiesUpToDate
Grant/Research SupportMedimmune; NIH/National Cancer Institute; Millennium; Genentech; Polaris Pharmaceuticals; Seattle Genetics; Boehringer-Ingelheim Pharmaceuticals; SWOG–Hope Foundation; American Cancer Society; Department of Defense; GlaxoSmithKline Pharmaceuticals; Merck; Eli Lilly; Takeda; Bristol-Myers Squibb