An oral targeted therapy approved for pancreatic cancer showed antitumor activity in previously treated lung cancer, according to early-phase data published Sept. 2 in The New England Journal of Medicine.
The drug, Rasonque (daraxonrasib), is an oral RAS inhibitor from Redwood City, Calif.-based Revolution Medicines. The FDA approved it Aug. 26 for metastatic pancreatic cancer, where it nearly doubled median overall survival from 6.7 months to 13.2 months on chemotherapy. The company is now testing it in non-small cell lung cancer, where it remains investigational.
RAS, or rat sarcoma, mutations are among the most common drivers of lung cancer, appearing in about 20% of cases. Existing targeted therapies reach only patients with a RAS G12C mutation; there are no approved targeted options for the other RAS mutations. Revolution Medicines aims to fill that gap with daraxonrasib.
The phase 1-2 trial enrolled 136 patients with previously treated RAS-mutant non-small cell lung cancer — excluding G12C — whose disease had progressed on platinum chemotherapy and immunotherapy. Confirmed objective response rates ranged from 31% to 37% across dose groups of 300 milligrams or less.
In a subgroup of 38 patients who had not received docetaxel and were treated at 160 milligrams to 220 milligrams, the response rate was 42% and the disease control rate was 89%. Median progression-free survival was 8.3 months and median overall survival was 16 months.
Grade 3 or higher adverse events occurred in 54% of patients across the doses studied, and four patients had fatal events. The most common side effects were rash and diarrhea.
The findings support RASolve 301, an ongoing phase 3 trial comparing daraxonrasib with docetaxel in previously treated RAS-mutant non-small cell lung cancer. Even before the pancreatic approval, some cancer centers prepared for high demand. An indication for lung cancer would widen the drug’s use to one of the largest patient groups with few targeted choices.
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