Early Clinical Data on Sotorasib in Advanced NSCLC
Posted: Tuesday, October 27, 2020
In patients with heavily pretreated, advanced non–small cell lung cancer (NSCLC), treatment with the KRAS G12C inhibitor sotorasib appears to provide durable responses, according to a phase I trial by David S. Hong, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues. Most patients achieved disease control, with an overall median progression-free survival of 6.9 months. The study findings were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 (Abstract 1257O).
The study included 40 patients with NSCLC, many of whom had received at least two previous lines of therapy (77.5%). The average age of patients was 68 years, and the median follow-up was 10.2 months.
The objective response rate was 30%, with a duration of response that ranged from 1.6 to 12.7 months; 7 of 12 responders were still in response at data cutoff. The disease control rate was 92.5%, and 18 patients (45%) developed progressive disease. At data cutoff, 10 patients (25%) were on study without disease progression, and 9 patients (22.5%) had died.
No significant association was identified between KRAS G12C–mutant allele frequency and response or PD-L1 expression and response. “The current limited data set suggests that neither KRAS G12C–mutant allele frequency nor PD-L1 expression level predicts response to sotorasib,” stated the authors.
As for safety, the authors had previously reported a favorable safety profile for patients treated with sotorasib; three patients (7.5%) had adverse events leading to discontinuation of therapy. There were no dose-limiting toxicities or fatal treatment-related adverse events reported.
Disclosure: For full disclosure of the study authors, visit oncologypro.esmo.org.