A daily pill has nearly doubled survival time in patients with advanced pancreatic cancer, trial results showed this week, offering the first significant treatment breakthrough for a disease that has resisted almost every therapy thrown at it for decades.
The drug, daraxonrasib, kept patients alive for a median of 13.2 months — compared to 6.6 months for those on standard chemotherapy. The results were presented at the American Society of Clinical Oncology annual meeting in Chicago and published simultaneously in The New England Journal of Medicine.
The trial enrolled 500 patients across North America, Europe, and Asia who had already received at least one line of chemotherapy and seen their disease worsen.
Why pancreatic cancer is so hard to treat
Pancreatic cancer carries the lowest five-year survival rate of any major cancer — just 13%. More than half of patients die within three months of diagnosis.
A large part of the problem is timing. Between 70 and 90 percent of patients are diagnosed only after the cancer has spread beyond the pancreas, by which point surgery — the only potential cure — is no longer possible.
Unlike lung, breast, or skin cancers, pancreatic cancer has never responded meaningfully to targeted therapies or immunotherapy. It has no approved gene-targeted treatment. Survival rates have barely moved in 30 years — from roughly six months in the late 1990s to nine to twelve months today.
“For years, the average survival for patients with advanced pancreatic cancers has hovered around one year,” said Dr. Anant Ramaswamy, a specialist in gastrointestinal cancers at Tata Memorial Centre in Mumbai. “Improvements in survival have been minimally incremental despite active research over the last two decades.”
How daraxonrasib works
The drug targets a protein produced by the KRAS gene — a mutation found in more than 90 percent of pancreatic cancers and in roughly 20 percent of all cancers, including lung and colorectal.
When KRAS mutates, it locks into a permanently active state, continuously signalling cells to grow and divide. That runaway signal is what drives tumour growth.
Daraxonrasib works from inside the cell. It binds to the activated protein and acts as a molecular clamp, physically switching the signal off.
“The net effect is to switch off the RAS pathway signalling and stop growth and spread of cancer,” said Dr. Eileen O’Reilly, a gastrointestinal oncologist at Memorial Sloan Kettering Cancer Center and the trial’s lead author.
What makes the drug especially significant is its broad reach. It suppresses RAS activity regardless of which specific variant is driving the cancer. No previously approved drug has achieved this.
“RAS, which has historically been considered undruggable, is now in the category of targetable genes in cancer,” O’Reilly said.
What the trial found
Of the 500 patients enrolled, nearly 92 percent carried a KRAS mutation. Patients were randomly assigned to receive either daraxonrasib or chemotherapy.
Those on daraxonrasib survived nearly twice as long. The drug also slowed disease progression and showed a higher rate of tumour shrinkage. Patients on daraxonrasib reported better quality of life for longer compared to those on chemotherapy.
Severe side effects occurred in 43.6 percent of patients on daraxonrasib, compared to 57.5 percent on chemotherapy. Common side effects included skin rash, diarrhoea, oral ulcers, fatigue, and anaemia. About one-third of patients required a dose reduction.
Experts noted two limitations: the trial was open-label, meaning patients knew which treatment they were receiving, and it was funded by Revolution Medicines, the drug’s manufacturer.
“It’s a big moment for patients with metastatic pancreatic cancer who have failed one line of chemotherapy,” said Dr. Pashtoon Kasi, medical director of gastrointestinal oncology at City of Hope Orange County. “They now could be getting another line of therapy and could have this pill as an option.”
What it means for India
India diagnoses between 15,000 and 17,000 new pancreatic cancer cases each year. The numbers are rising, driven in part by increasing rates of diabetes and obesity — both established risk factors for the disease. Outcomes in India tend to be worse than global averages, largely because most patients reach a specialist only at an advanced stage.
Daraxonrasib is not currently available in India. The US Food and Drug Administration has fast-tracked its review, with approval expected within months. On May 1, the FDA authorised the drug’s manufacturer to provide it through an expanded access programme for eligible patients.
The path to India will take longer — domestic regulatory approvals, pricing negotiations, and access programmes all lie ahead. Dr. Ramaswamy said clinical trials testing this class of drugs already have long waiting lists.
“With the kind of scope it has, I think this class of drugs will soon make their way to India,” he said. “Everyone is interested in these drugs because of their potential to treat a number of cancers.”
What comes next
Researchers are already running trials of daraxonrasib in earlier-stage pancreatic cancer patients — those who have not yet received any chemotherapy. Separate studies are underway for lung and colon cancers, which share similar KRAS mutations.
“The success in pancreatic cancer serves as a powerful proof-of-concept that could unlock new therapies across oncology,” said Dr. Tracy Proverbs-Singh, a gastrointestinal oncologist at Hackensack University Medical Center.
For Dr. Ramaswamy, the moment carries a significance beyond the data.
“In such a scenario, the impact of an oral pill doubling survival in pre-treated patients with pancreatic cancer is great news,” he said. “This is just the beginning for this new class of drugs.”
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