Daraxonrasib may offer new hope in previously treated pancreatic cancer
Oral therapy shows 'unprecedented survival benefit' in pivotal trial
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Most people with previously-treated metastatic pancreatic cancer lived for at least one year after receiving the oral therapy candidate daraxonrasib in a clinical trial — a result that daraxonrasib’s developer Revolution Medicines described as an “unprecedented overall survival benefit” in this hard-to-treat cancer.
Median survival among participants given daraxonrasib was approximtely double that of patients treated with standard chemotherapy, the data showed. All of the patients had metastatic disease, meaning the cancer had spread beyond the pancreas to other parts of the body.
“In this pivotal trial, daraxonrasib as a targeted medicine delivered a dramatic improvement in overall survival in patients with previously treated metastatic pancreatic cancer compared to standard of care chemotherapy, consistent with earlier findings,” Mark A. Goldsmith, MD, PhD, CEO and chairman of Revolution, said in a company press release announcing that the trial met all its primary and key secondary goals.
“These results represent a potentially transformative advance for patients and underscore daraxonrasib’s potential to redefine the treatment landscape,” Goldsmith said.
Revolution is planning to submit this data to the U.S. Food and Drug Administration and other global regulatory authorities as part of applications seeking the drug’s approval. The therapy is designed to block the activity of the RAS protein, a driver of cancer growth that is mutated in many cancer types.
“We are moving with urgency toward global regulatory submissions and remain committed to rapidly advancing this therapy for patients with a broad range of RAS-addicted cancers,” Goldsmith said.
The Phase 3 clinical trial (NCT06625320), dubbed RASolute 302, enrolled approximately 500 people with pancreatic ductal adenocarcinoma (PDAC), the most common type of pancreatic cancer. The study was open to patients whose cancers carried a range of RAS mutations, as well as those with no known RAS mutation. Each of the participants had metastatic disease, and all had previously received standard first-line treatment.
All participants were randomly assigned to receive either daraxonrasib or a standard combination of chemotherapies, and the study’s main goals were to see if daraxonrasib would delay disease progression and extend survival.
Patients on daraxonrasib lived for more than 1 year
The results showed that the median survival time with daraxonrasib was 13.2 months, compared with 6.7 months for standard chemo. Mathematically, that works out to a roughly 60% decreased risk of death with daraxonrasib.
I believe that this new approach … will be practice-changing for physicians and improve the care for patients with previously treated metastatic pancreatic cancer.
Revolution said the therapy was generally well tolerated, with a manageable safety profile consistent with that seen in other studies. The company didn’t provide further details, noting that the trial’s in-depth results will be presented at a scientific meeting later this year.
“For patients with metastatic pancreatic cancer, new treatment options are urgently needed to increase survival time and improve quality of life,” said Brian M. Wolpin, MD, the trial’s principal investigator. Wolpin, a professor at Harvard Medical School, serves as the director of the Hale Family Center for Pancreatic Cancer Research at the Dana-Farber Cancer Institute in Boston.
“The widely anticipated results of this study indicate that daraxonrasib provides a clear and highly meaningful step forward for patients with pancreatic cancer who have experienced progression on prior treatment, typically chemotherapy,” Wolpin said.
He added: “I believe that this new approach is a very important advance for the field that I expect will be practice-changing for physicians and improve the care for patients with previously treated metastatic pancreatic cancer.”
Ongoing trials testing therapy candidate in other settings
Revolution is also running several other clinical trials testing daraxonrasib in various settings for pancreatic cancer treatment.
One trial, RASolute 304 (NCT07252232), is testing whether daraxonrasib, in addition to standard chemo, can reduce the risk of cancer coming back following surgery. That study is recruiting at sites in the continental U.S., Puerto Rico, and the U.K.
Another trial, RASolute 303 (NCT07491445), is testing the therapy in first-line metastatic PDAC, with recruitment open at two U.S. sites.
