Objective response seen in 37.1 percent of patients with previously treated KRAS p.G12C-mutated non-small cell lung cancer
WEDNESDAY, June 9, 2021 (HealthDay News) — Sotorasib therapy yields clinical benefit for patients with previously treated KRAS p.G12C-mutated non-small cell lung cancer (NSCLC), according to a study published online June 4 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held virtually from June 4 to 8.
Ferdinandos Skoulidis, M.D., Ph.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues conducted a single-group, phase 2 trial to examine the activity of sotorasib, administered orally once daily in 124 patients with KRAS p.G12C-mutated advanced NSCLC previously treated with standard therapies. The primary end point was objective response (complete or partial).
The researchers found that 46 patients (37.1 percent) had an objective response, including four and 42 who had a complete and partial response, respectively; the median response duration was 11.1 months. One hundred of the patients had disease control. The median progression-free survival and median overall survival were 6.8 and 12.5 months, respectively. Treatment-related adverse events occurred in 69.8 percent of patients, including grade 3 and 4 events in 19.8 and 0.8 percent, respectively. In subgroups defined according to programmed death ligand-1 expression, tumor mutational burden, and co-occurring mutations in STK11, KEAP1, or TP53, responses were observed.
“This trial provides convincing evidence that mutant KRAS can be successfully and selectively targeted, resulting in meaningful prolongation of survival without compromising quality of life,” Skoulidis said in a statement.
Several authors disclosed financial ties to biopharmaceutical companies, including Amgen, which manufactures sotorasib and funded the study.
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