(Corrects paragraph 5 to say “doubled” not “reduced”)
By Julie Steenhuysen
CHICAGO, May 31 (Reuters) – Revolution Medicine’s experimental pancreatic cancer pill doubled survival compared with chemotherapy and improved symptoms enough that some patients could resume activities they had previously abandoned, setting a new benchmark for this deadly cancer, researchers reported on Sunday.
Full results of the 500-person trial, which tested the once-daily pill against standard chemotherapy in patients who had failed one round of chemotherapy, showed that daraxonrasib reduced the overall risk of death by 60% compared with patients with advanced pancreatic cancer treated with chemotherapy.
The treatment also halted or reversed tumor progression by nearly a third overall compared with just 10% in those given chemotherapy, according to results of the study which were presented on Sunday at the American Society of Clinical Oncology.
“It ticks all of the boxes,” said Dr. Rachna Shroff, University of Arizona Cancer Center and ASCO expert in pancreatic cancer, saying that a doubling of survival and reduction in the risk of death has never been seen in patients whose cancer progressed after chemotherapy.
Preliminary results released on April 13 showed the drug doubled the time from diagnosis to a patient’s death to 13.2 months versus 6.7 months for those on standard chemotherapy, sending shares of the company up 40%.
“These results will change how scientists, clinicians, and patients think about treatment for pancreatic cancer,” said Dr. Brian Wolpin of Harvard’s Dana-Farber Cancer Institute and principal investigator of the trial.
A key concern with the drug has been rash, which was experienced by 86.3% of patients on the drug after the start of treatment, but Wolpin said it is largely manageable with antibiotics and topical steroids.
EXTENDING THE BENEFIT
Pancreatic cancer has the highest mortality rate of all major cancers. According to the American Cancer Society, some 68,000 Americans will be diagnosed with pancreatic cancer this year and roughly 53,000 will die.
Typically, just 3% of patients whose cancer has spread from the pancreas to distant organs are alive after five years. About 80% of patients are diagnosed in the advanced or metastatic stage.
Mark Goldsmith, chief executive of Revolution Medicines, said the company is already testing daraxonrasib in earlier-stage disease and in combination with other treatments in hopes of extending its ability to “significantly elevate” survival.
Menta “Steve” Wallace, a 74-year-old from Houston, Texas, is in one of those trials. He was diagnosed with pancreatic cancer in January after noticing some pain in his abdomen.
He was admitted to a trial of daraxonrasib as an initial or first-line treatment through University of Texas MD Anderson Cancer Center and received his first treatment on February 12.
After some initial nausea and diarrhea and rash he described as “not bad at all,” he is now feeling well and “very pleased.” His last scan showed his tumor had shrunk by 46%.
An avid traveler, Wallace and his wife had plans to travel the world in retirement. Those were put on the back burner until last week, when Wallace got the green light. He plans to pack his pills on ice and take a Caribbean cruise at the end of June.
FIRST IN CLASS
Daraxonrasib is the first in a new class of drugs called RAS(ON) inhibitors targeting variants of the RAS gene that drive cancer growth.
In patients with a known RAS mutation called G12, tumors remained under control for a median of 7.3 months among those on daraxonrasib versus 3.5 months with chemotherapy. The result was similar in the overall population.
The percentage of patients whose cancer shrank or disappeared was about 33.2% in patients with the G12 mutation versus about 11.8% in the chemotherapy arm. In the overall population, 31.6% of patients saw their tumors shrink or disappear compared with 11.2% who received chemotherapy.
The most common side effects were inflammation in the mouth, nausea and diarrhea and rash, experienced by 86.3% of patients.
Severe or life-threatening side effects were 43.6% in the daraxonrasib treatment group, versus 57.5% in the chemotherapy arm, higher than in an earlier smaller study.
Rash was the most frequent severe side effect, occurring in 14% of patients, followed by stomatitis or mouth sores and inflammation, which occurred in 12% of patients.
Jefferies analyst Faisal Khurshid ahead of the results was hoping to see less than 10% of patients with severe rash. Just 1.2% of patients given daraxonrasib dropped out of the trial because of side effects, compared with 11.2% among those who were on chemotherapy.
The Food and Drug Administration granted on May 1 expanded access to the drug and plans a speedy review.
MD Anderson’s Dr. Shubham Pant, a co-principal investigator of the trial, said one of his patients, an avid golfer who was forced to give up the sport, was able to reduce his reliance on narcotics and resume playing golf after a month on treatment.
“I have multiple patients like that,” he said.
(Reporting by Julie Steenhuysen; Editing by Alistair Bell)
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