An experimental drug, daraxonrasib, initially approved for advanced pancreatic cancer, may also hold promise for a particular subtype of lung cancer, according to early clinical trial results. The drug is being developed by Revolution Medicines under the brand name Rasonque.
In a Phase 1 clinical trial, 136 patients with non-small cell lung cancer (NSCLC) who had not responded to previous therapies were given daily doses of daraxonrasib. These patients had genetic mutations in RAS proteins, which are known to drive tumor growth. The study, published in The New England Journal of Medicine, indicated that the drug was safe and effectively reduced tumor size in over 30% of participants across different dosage groups.
Tumor reduction rates ranged from 31% in the lower dose group to 37% in the highest dose group. While generally safe, nearly all participants experienced side effects. The most common adverse effects included rash, diarrhea, nausea, and vomiting. Some patients also developed mucositis (inflammation of the digestive tract's mucous membranes), stomatitis (inflammation of the mouth's mucous membranes), pneumonia, and low blood cell counts.
Lung cancer is a leading cause of cancer death in the U.S. and globally. The American Cancer Society estimates about 230,000 new diagnoses and 125,000 deaths this year in the U.S. alone. NSCLC accounts for more than three-quarters of all lung cancer cases. The lifetime probability of developing lung cancer is approximately 1 in 19.
The U.S. Food and Drug Administration (FDA) is likely to require further late-stage clinical trials with a larger patient pool before considering daraxonrasib for lung cancer treatment approval.
Daraxonrasib recently received FDA approval for patients with metastatic pancreatic adenocarcinoma who have undergone at least one prior systemic therapy. This approval followed a late-stage trial where the drug nearly doubled median overall survival to over 13 months, compared to about 6.7 months for patients on standard chemotherapy. The drug was granted