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4w ago

Daraxonrasib Doubles Survival in Treated Metastatic Pancreatic Cancer in Phase 3 Trial

Published in the New England Journal of Medicine after an ASCO presentation, regulators have authorised expanded access for daraxonrasib pending formal review.

Image
3D illustration of human body organs.
*SINGLE USE** Pancreatic cancer cells. Coloured scanning electron micrograph (SEM) of pancreatic cancer cells. Pancreatic cancer often causes no symptoms until it is well established and untreatable. The cellular processes seen here allow the cells to move. They may clump to form tumours and invade surrounding tissue (metastasis).
A microscopy image of yellow, textured pancreatic cancer cells.

Overview

  • The randomized Phase 3 RASolute 302 trial, presented May 31 at ASCO, showed median overall survival of 13.2 months with daraxonrasib versus about 6.6–6.7 months with standard chemotherapy and a roughly 60% lower risk of death.
  • Daraxonrasib is an oral RAS(ON) multi-selective inhibitor that acts like a 'molecular glue' by binding cyclophilin A and then engaging mutant KRAS to block its growth signal.
  • The drug produced higher response rates and disease control, with objective response about 31.6% versus 11.2% for chemotherapy and similar progression-free survival gains.
  • Toxicities differ from chemo: about 86% of patients developed rash and roughly 14% had severe rash, but severe adverse events were lower overall and treatment discontinuation was much rarer with daraxonrasib.
  • The FDA has authorised an expanded access pathway while Revolution Medicines prepares an expedited regulatory filing, clinics report surging demand, and investigators are testing earlier use, combinations, and biomarkers to understand resistance.