The researchers at New England Journal of Medicine have found Sotorasib to be safe having clinical benefit in non-small cell lung cancer (NSCLC). The results of the study were presented at the virtual meeting of the European Society for Medical Oncology and involved 129 patients with KRAS-mutated cancers, including NSCLC. Three-quarters of these had tried two or more treatment and all have undergone chemotherapy and nearly 90% have tried PD-1/PD-L1 drug.
The Phase I data come from 59 patients with non-small cell lung cancer, who received one of the four dose levels. Sotorasib demonstrated confirmed Objective Response Rate (ORR) and Disease Control Rates (DCR) of 35.3% and 91.2% respectively in 34 heavily pretreated patients with NSCLC. The top dose of 960mg worked to shrink tumor in 35% of patients compared to 32% of all dose levels. Anti-cancer activity was seen across all dose levels in NSCLC patients. During the first week-6 assessment, tumor shrinkage was observed in 71.2% of patients.
According to the researchers, the safety profile of the drug looks good, with just over half of the patients suffered treatment-related side effects such as fatigue, nausea etc. Professor Fabrice Barlesi, medical director of Gustave Roussy Institute, Paris, France commented “There are currently no approved targeted therapy options for KRAS G12C and patients remain in need of additional treatment options, which makes these new findings particularly important.”
Though Sotorasib findings are in early stage, but the consensus of opinion from virtual conference was that it could be breakthrough in the treatment of KRAS-positive cancers.
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