FDA approves daraxonrasib as Elicio preps Phase 1 trial combining it with camupepimut

The FDA approved daraxonrasib, sold as RASONQUE by Revolution Medicines, Inc. The drug is an inhibitor of the RAS GTPase family cleared for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.¹

The approval lands as Elicio Therapeutics advances plans to combine daraxonrasib with its own candidate. Elicio reported third quarter 2026 results on November 5, 2026, and said it is targeting a fourth quarter 2026 initiation of a Phase 1 study evaluating camupepimut with daraxonrasib, with or without nivolumab, in metastatic KRAS-mutated pancreatic ductal adenocarcinoma². The study will explore the combined potential of direct RAS inhibition, KRAS-specific immune activation and checkpoint blockade.²

Elicio also presented new pre-specified analyses from the Phase 2 "AMPLIFY-7P" trial in resected pancreatic cancer at ESMO Congress 2026. The analyses showed a 49% reduction in the risk of disease recurrence or death in ctDNA-negative patients, a 43% reduction in ctDNA-positive patients, and a 41% reduction in patients without prior radiation.² The trial did not meet its primary disease-free survival endpoint in the intent-to-treat population, though a supportive multivariable analysis adjusting for baseline prognostic imbalances estimated a 53% reduction in the hazard of recurrence or death (HR 0.47; p=0.0086).² Peer-reviewed Phase 2 findings were also published in Nature Medicine.²

Separately, an investigator-initiated Phase 1 neoadjuvant study evaluating camupepimut with chemotherapy and anti-PD-1 therapy in resectable and borderline resectable pancreatic cancer is ongoing, led by Memorial Sloan Kettering Cancer Center and funded through a partnership between The Lustgarten Foundation and Break Through Cancer.²

On finances, cash and cash equivalents were $30.9 million as of September 30, 2026², and the company said its current cash and cash equivalents will support operations into the second quarter of 2027².