A new era in the treatment of advanced pancreatic cancer may soon be on the way. An experimental oral drug called daraxonrasib has just shown remarkable results in a late stage clinical trial.
On Monday, Revolution Medicines disclosed its Phase III trial data of daraxonrasib for people with previously treated metastatic pancreatic cancer. The drug passed with flying colors, nearly doubling people’s typical length of survival compared to standard care. Daraxonrasib will likely become the first medication of its kind approved for these historically difficult-to-treat cancer cases, with a decision from the Food and Drug Administration expected within months.
“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,” said lead trial researcher Brian Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at the Dana-Farber Cancer Institute, in a statement released by the company.
A game changer
Cancer treatment as a whole has greatly improved over the past several decades, to the point that people diagnosed with cancer are living longer than ever. One of the biggest exceptions to that progress, however, has been pancreatic cancer. Even today, the five-year survival rate of pancreatic cancer is still only around 13%.
There are several reasons why this form of cancer has proven so difficult to treat. There are no screening tests for the average person currently, for instance, meaning that many tumors go unnoticed until they’ve already spread beyond the pancreas (making surgery unlikely to work well). Pancreatic cancers also tend to be more resistant to conventional chemotherapy, in part due to the thick tissues that form around tumors.
Daraxonrasib is intended to work around some of these limitations by targeting a protein called RAS. The vast majority of pancreatic cancers (more than 90%, according to RevMed) develop RAS mutations, which help drive the growth of tumors. So the drug is designed to broadly inhibit RAS variants, in theory allowing it to tackle a wide range of pancreatic cancers.
The RASolute 302 trial involved roughly 500 patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). PDAC is the most common form of pancreatic cancer. Half were randomized to receive standard care (a mix of various chemotherapy drugs), and half received a daily dose of daraxonrasib. The trial included people with or without RAS-associated tumors.
The drug surpassed all of the primary and secondary goals set by the study researchers. Overall, the median length of survival for people on daraxonrasib was 13.2 months, compared to 6.7 months for people on standard chemotherapy. The drug also appeared to be generally well-tolerated, with no unexpected safety signals, according to the company.
What comes next
These findings still have to undergo the typical peer-review process, an important part of vetting any scientific research. But, assuming the math is all legitimate, it’s hard to imagine that the FDA will not greenlight daraxonrasib for approval. And once that happens, it should significantly change the landscape of pancreatic cancer treatment.
While six additional months of survival might not seem like too dramatic a benefit, it certainly can be for someone with no other treatment options. And it’s worth noting that some people will probably experience greater success, perhaps years of extra life or even a sustained remission. It’s also possible that the drug will be even more effective when started earlier, as opposed to after other treatments have already failed.
The drug’s likely approval is about more than just daraxonrasib alone, too. It will signify that RAS inhibitors are a viable drug class for pancreatic cancer, encouraging scientists and companies to develop their own, possibly better versions. With enough time and a little luck, pancreatic cancer could very well become a readily treatable condition, similar to other types of cancer.
RevMed is planning to file daraxonrasib for FDA approval using a Commissioner’s National Priority Voucher, which is intended to shorten the review process within one to two months. So the therapy could potentially reach patients as early as this summer.
