Dive Brief:
- Revolution Medicines’ closely watched pancreatic cancer drug helped control tumors when administered early in a patient's disease course, stimulating a response in at least half of those who got it either as a single treatment or alongside chemotherapy, according to trial results unveiled at a medical meeting Tuesday.
- The findings disclosed at the American Association for Cancer Research’s annual convention come from studies testing the therapy, daraxonrasib, in first-line pancreatic cancer. They follow, by a week, Phase 3 data showing the drug nearly doubled survival in people whose disease had progressed after an earlier treatment, sparking a share surge that has launched the company’s valuation past $30 billion.
- The Food and Drug Administration gave Revolution a special regulatory fast-pass that could lead to a clearance within weeks of an approval submission. The drug’s potential to upend treatment in pancreatic cancer has prompted many Wall Street analysts to view Revolution as a prime takeover target, although rumors have cooled since Merck & Co. reportedly pulled out of acquisition talks.
Dive Insight:
Daraxonrasib is part of a new generation of medicines aimed at the family of “RAS” proteins that have historically been tough to reach with pharmaceuticals. RAS mutations are present in 90% of pancreatic cancer cases, rendering a drug that can effectively stifle those proteins a potentially important advance.
The data Revolution reported last week came from a Phase 3 trial testing whether daraxonrasib can extend survival in people with a specific mutation called RAS G12. The therapy, though, appears more broadly effective, helping people with other RAS mutations or none at all.
The early-stage data presented Tuesday afternoon signal the drug’s reach might extend even further. They’re from trials in which daraxonrasib is being tested either alone or with chemotherapy on enrollees with different types of solid tumors. The data in pancreatic cancer came from a group of 38 RAS-mutated patients receiving daraxonrasib as a single therapy and 40 who got it with chemotherapy.
Study investigators reported that tumors shrank or disappeared in 47% of those in the monotherapy group, and 71% were alive and hadn’t seen their disease progress at six months. In the group that received daraxonrasib and chemotherapy, those numbers were 58% and 84%, respectively.
By comparison, standard first line chemotherapy elicits a response in 23% to 43% of people and is associated with six-month progression-free survival rates of 40% ro 50%, researchers said.
The data help affirm the company’s decision to conduct a Phase 3 trial in first-line pancreatic cancer, “RASolute303,” that just began enrolling patients and will randomize them to receive either chemotherapy, daraxonrasib, or those two interventions combined, the company said.
“What I find notable about these datasets is the strength of antitumor activity observed with daraxonrasib across both monotherapy and combination therapy, along with manageable safety profiles,” said Eileen O’Reilly, chair of medical oncology at Memorial Sloan Kettering Cancer Center, and an investigator in the monotherapy trial, in a statement provided by Revolution.
“With longer follow up, these results further support the potential of a novel RAS-targeted therapy to meaningfully improve outcomes in frontline metastatic [pancreatic cancer],” O’Reilly added.
Revolution also revealed data this week from a trial of a separate RAS-targeting drug in lung cancer.
