By Nancy Lapid
May 6 (Reuters) – An experimental drug from Revolution Medicines that nearly doubled survival time for patients with advanced pancreas cancer in clinical trials comes with a high rate of mostly low-grade side effects, researchers reported on Wednesday.
The report from a first-in-human trial of daraxonrasib is the first peer-reviewed paper to show safety data for what analysts say could become the next standard of care for previously treated metastatic pancreatic cancer.
Pancreatic cancer is among the most deadly forms of cancer globally, with one of the lowest five-year survival rates of any cancer, often cited at around 13%.
The new findings support an ongoing late-stage trial comparing daraxonrasib to usual second-line chemotherapy for patients with pancreatic cancer that has spread to other parts of the body, researchers said in a statement.
Among the 168 patients with previously treated pancreatic ductal adenocarcinoma who received daraxonrasib in the early trial, treatment-related adverse side effects of any grade occurred in 96%, while severe or life-threatening events were reported in 30%.
The most common side effects reported were rash, inflammation in the mouth, nausea and diarrhea.
“Almost all patients do experience some adverse effects, with the most common being a rash that occurs in the majority of patients,” said senior researcher Dr. David Hong of the University of Texas MD Anderson Cancer Center in Houston. “But those effects are manageable in most patients, and the benefits significantly outweigh those adverse effects.”
In the ongoing late-stage trial involving 500 patients, median overall survival is 13.2 months with daraxonrasib versus 6.7 months with standard chemotherapy, Revolution said in April.
With usual drug regimens for previously treated metastatic pancreas cancer, serious or life-threatening side effects are common, and median overall survival is 5 to 7 months, the researchers noted in a report published in The New England Journal of Medicine.
Participants in both trials have common mutations in so-called KRAS tumor genes that help cancer cells divide and multiply. Drugs that inhibit these genes are already available to treat lung and colorectal cancers, but they are active against a RAS mutation rarely seen in pancreatic cancer.
Daraxonrasib, given daily as a pill, targets the RAS mutations seen in 90% of pancreatic cancers.
“Although much work remains to be done, it genuinely feels like a new day is dawning for pancreatic cancer treatment, with daraxonrasib potentially serving as the first of a set of new medicines that broadly target mutant RAS and allow us to help patients with pancreatic cancers in new ways,” study leader Dr. Brian Wolpin of Dana-Farber Cancer Institute in Boston said in a statement.
Earlier this month, the U.S. Food and Drug Administration authorized early access to daraxonrasib, allowing patients to receive the experimental treatment outside clinical trials before approval.
(Reporting by Nancy Lapid in Tucson, Arizona and Kamal Choudhury in Bengaluru; Editing by Bill Berkrot)
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