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FDA Approves Daraxonrasib for Metastatic Pancreatic Cancer Following Landmark Clinical Trial Led by Dana-Farber
he U.S. Food and Drug Administration (FDA) has approved daraxonrasib, an oral multi-selective RAS(ON) inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
To report the FDA approval of daraxonrasib, the first RAS-targeted therapy for metastatic pancreatic cancer, based on the results of the RASolute 302 trial.
Approach:
Trial Overview: The RASolute 302 trial was a pivotal randomized phase 3 study comparing daraxonrasib to chemotherapy in patients with metastatic pancreatic cancer.
Patient Population: The trial enrolled 500 patients who had previously received one line of chemotherapy for metastatic disease.
Treatment Comparison: Patients were randomized to receive either daraxonrasib or a second line of chemotherapy.
Key Findings:
Daraxonrasib nearly doubled median overall survival compared to chemotherapy (13.2 months vs. 6.7 months).
Daraxonrasib reduced the risk of death by 60% (hazard ratio of 0.40).
Median progression-free survival was 7.2 months with daraxonrasib compared to 3.6 months with chemotherapy.
Objective response rate was 31.6% for daraxonrasib versus 11.2% for chemotherapy.
Among patients with a known RAS G12 mutation, 33.2% experienced substantial tumor shrinkage with daraxonrasib.
Limitations:
The study population was limited to patients who had received one prior line of chemotherapy.
Long-term efficacy and safety data beyond the trial duration are not yet available.
