Daraxonrasib trial exceeds expectations after decades of disappointment in pancreatic cancer drug development
A study participant in teh trial of daraxonrasib felt like he was part of something special, says UT MD Anderson's Subam Pant, "and he is."
Positive results from phase 1 trials have historically flamed out and had to be discounted by 60%.
Shubham Pant, M.D., M.B.B.S., was cautiously optimistic about daraxonrasib but put the emphasis on the caution.
Pant, a professor of gastrointestinal medical oncology at The University of Texas MD Anderson Cancer Center in Houston, said he was fairly confident that the open-label, phase 3 trial comparing daraxonrasib, a once-a-day pill, against one of four choices of chemotherapy would come out in daraxonrasib’s favor.
“But I was, like, in pancreatic cancer; you never know, because, 20 negative trials later, it can burn anybody. I'm an optimistic person by nature, but it can burn somebody.”
Results of the RASolute 302 study of daraxonrasib were presented Sunday at the plenary session of the 2026 annual meeting for the American Society of Clinical Oncology (ASCO) in Chicago. The results, which garnered the most attention of any findings presented at the meeting, showed that daraxonrasib exceeded by a wide margin he chemotherapy regimens on the primary end points of overall survival and progression-free survival. The study, which was sponsored by Revolution Medicines, the maker of daraxonrasib, showed that the overall survival among the 228 study participants randomly selected to be treated with daraxonrasib was 13.2 months compared with 6.6 months among the 231 study participants who were treated with chemotherapy. The patients in the study had all been previously treated, and most of the study participants had RAS G12 mutation.
Researchers and clinicians are heralding daraxonrasib as a major advance in the treatment of pancreatic cancer, which remains one of the deadliest cancers in the U.S. with a five-year rate of just 13.7%. In comparison, the five-year survival of lung and bronchus cancer is 29.5%, and the five-year survival rate for breast cancer is approximately 90%.
The results for phase 3 daraxonrasib didn’t come out of the blue. They were preceded by findings from a phase 1 trial that also indicated an overall survival rate of approximately 13.1 months. The RASolute 302 results were remarkable, Pant said, because the overall survival rates held when historically, phase 1 results have to be discounted by 60%, Pant said.
Pant said he shared the positive results of the trial to a patient who is enrolled in the trial. “We just had a great moment. He just felt he was part of something special, and he is,” Pant said.
