Experimental Pancreatic Cancer Drug Daraxonrasib Nearly Doubles Survival in Phase 3 Trial

An experimental pancreatic cancer treatment called daraxonrasib nearly doubled survival time in a phase 3 clinical trial, according to findings presented at the American Society of Clinical Oncology (ASCO) annual meeting. The drug, developed by Revolution Medicines, targets the KRAS protein, which drives more than 90% of pancreatic cancers, and is now under review for FDA approval.

What Is Daraxonrasib?

Daraxonrasib is an oral medication designed to inhibit the KRAS protein, a key driver of pancreatic cancer growth. Unlike traditional chemotherapy, which attacks rapidly dividing cells broadly, daraxonrasib specifically targets KRAS mutations, which are present in over 90% of pancreatic cancer cases, according to Peter Hosein, MD, associate director for clinical research at Sylvester Comprehensive Cancer Center. “This is the first panRAS inhibitor to show success in a large phase 3 study,” he said.

The drug is not yet FDA-approved but has entered an expanded access program, allowing eligible patients to receive it through their oncologists. “Oncologists can apply for their patients to access the drug while it undergoes final regulatory review,” said Shubham Pant, MD, a gastrointestinal oncologist at the University of Texas MD Anderson Cancer Center.

What Did the Clinical Trial Reveal?

The phase 3 trial, involving 500 patients with metastatic pancreatic ductal adenocarcinoma (mPDAC), found that daraxonrasib extended median overall survival to 13.2 months compared to 6.6–6.7 months for chemotherapy. The results, presented at ASCO in June 2024, showed the drug also reduced severe side effects, with only 1.2% of patients discontinuing treatment due to adverse effects, versus 11.2% in the chemotherapy group.

“We’ve never seen results of this caliber in pancreatic cancer treatment,” said Ignacio Garrido Laguna, MD, PhD, chair of early therapeutics development at Moffitt Cancer Center. “This represents a major step forward for a disease with historically poor outcomes.”

Why Is This Drug Significant?

Pancreatic cancer remains one of the deadliest cancers, with a five-year survival rate of 13% overall and just 3% for stage IV patients, according to the Cleveland Clinic. The disease is often diagnosed at advanced stages, limiting treatment options. “Most patients are diagnosed with metastatic disease, which makes curative approaches nearly impossible,” said Brandon Huffman, MD, a medical oncologist at Dana-Farber Cancer Institute.

Daraxonrasib’s mechanism of action sets it apart from existing therapies. While other drugs target specific KRAS mutations like G12C, daraxonrasib inhibits all subtypes, offering broader applicability. “This is a critical first step in blocking the main driver of pancreatic cancer growth,” Huffman said. However, experts caution the drug is not a cure. “Resistance will eventually develop, and survival gains are incremental,” he added.

How Can Patients Access Daraxonrasib?

Revolution Medicines has launched an expanded access program for eligible patients. Oncologists in the U.S. can apply for their patients to receive the drug through this initiative. “Patients should discuss this option with their care team to determine if they qualify,” Pant said.

The FDA is expected to review daraxonrasib’s approval request in the coming months. Meanwhile, researchers continue to explore combination therapies to delay resistance and improve long-term outcomes.

What’s Next for Pancreatic Cancer Treatment?

The success of daraxonrasib highlights the potential of targeted therapies in oncology. “This trial underscores the importance of precision medicine in addressing cancers driven by specific genetic mutations,” said Hosein. However, challenges remain, including early detection and overcoming drug resistance.

“While this is a promising development, we need more tools to diagnose pancreatic cancer at earlier stages,” Laguna said. “Until then, therapies like daraxonrasib offer hope for extending survival and improving quality of life for patients.”