A new pill could be the future of treatment late-stage pancreatic cancer in the U.S., nearly doubling the length patients live compared to those on chemotherapy, clinical oncology company Revolution Medicines said Monday.
Pancreatic caner patients, who have some of the worst prognosis rates among all cancer patients, taking the once-daily drug daraxonrasib as part of a 500-person Phase 3 trial had a 60 percent reduced risk of death compared to those just on chemotherapy, suggesting the pill could be a more effective and less invasive route of treatment.
It could also be a more successful option for patients who still see the cancer spread while on chemotherapy, Dr. Brian Wolpin, a professor of medicine at Harvard Medical School and the principal investigator for the trial, said in a statement.
“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,” he said.
The announcement comes as pancreatic cancer cases and deaths have risen markedly over the last decade in younger adults. Pancreatic cancer is the third-leading cause of cancer deaths in the U.S. and about 67,530 cases and 52,740 deaths are expected this year, according to the American Cancer Society.
Pancreatic cancer remains the deadliest major cancer, and the only one with a five-year survival rate below 20 percent, the Pancreatic Cancer Action Network says. For those with late-stage pancreatic cancer, the survival rate drops to just a year after diagnosis, according to Johns Hopkins Medicine.
That’s why treatments that can help extend survival are so crucial, Wolpin said.
Late-stage patients on chemotherapy typically live for an average of 6.7 months after treatment. But those taking a 300 milligram dose of daraxonrasib each day lived for 13.2 months, the new trial, which is ongoing, found.
Why is daraxonrasib so effective? Revolution Medicines says the “unprecedented” results are tied to its ability to block a gene called RAS. When RAS mutates, it causes various forms of cancer.
The company says it plans to submit the data to the U.S. Food and Drug Administration as part of a future new drug application. The company was selected by the agency for a new voucher program that expedites promising medicines.
“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,” commented Dr. Mark Goldsmith, Revolution Medicines’ chief executive, said.
Daraxonrasib was first in the headlines this month when former Republican Sen. Ban Sasse told The New York Times that he was taking the once-daily pill after being diagnosed with stage four pancreatic cancer.
Sasse, 54, said it is a “nasty drug” — though his tumors have shrunk by 76 percent since he started the treatment.
“It causes crazy stuff like my body can’t grow skin and so I bleed all out of a whole bunch of parts of me that shouldn’t be bleeding,” he said.
Common side effects of daraxonrasib include rash, vomiting, fatigue, nausea, diarrhea, constipation, inflammation, mouth sores, liver inflammation, a decrease in red blood cells, scaly skin and effects on the kidneys, according to the U.K.’s trial registry.
The side effects of chemotherapy are similar. Chemotherapy may cause nausea and vomiting, diarrhea, mouth sores, nerve problems , hair loss, fatigue, constipation, incontinence, weight changes, anxiety, depression and reduced counts of platelets, white blood cells, red blood cells, the American Cancer Society says.
While the possible advantages daraxonrasib could be better than chemotherapy and a more personalized approach to treatment, the side effects are one of the downsides and a lot remains unknown about the pill, oncologist Dr. Christopher Lieu, a professor at the University of Colorado Anschutz Department of Medicine, explained in a statement in February.
“Currently, we have early data in a small number of patients about these outcomes as it relates to daraxonrasib, but we don’t know what the outcomes will be in a much larger group of people and how it compares to chemotherapy,” he said.
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