Pancreatic Cancer Drug Shows Early Promise Against Lung Cancer

Pancreatic Cancer

A new lung cancer drug already approved for advanced pancreatic cancer is now showing signs it could work against a second, more common cancer. Daraxonrasib, sold under the brand name Rasonque, shrank tumors in more than 30% of non-small cell lung cancer patients during an early-phase trial, according to results published September 3, 2026, in the New England Journal of Medicine.

The findings mark a potential expansion for a drug that only received FDA approval for pancreatic cancer last week. Researchers caution that larger, late-stage trials are still needed before daraxonrasib could be approved specifically as a non-small cell lung cancer treatment.

Trial Results for the New Lung Cancer Drug

Researchers enrolled 136 patients with non-small cell lung cancer, all of whom had already tried other therapies without success. Every patient carried RAS gene mutations, which are known to drive tumor growth. Patients received daily doses of daraxonrasib in three-week cycles.

Tumor response rates by dose:

Dose group

Patients with reduced tumors

Lowest dose

31%

Middle dose

34%

Highest dose

37%

The dose-response pattern is notable on its own. Response rates climbed steadily with dose, a signal researchers point to as evidence the drug is producing a real biological effect rather than a random result.

Who this RAS-Targeted Treatment Could Help

  • Patients with confirmed RAS gene mutations
  • Patients whose non-small cell lung cancer has resisted chemotherapy or targeted therapy
  • Patients with few remaining treatment options

Non-small cell lung cancer makes up more than three-quarters of all lung cancer diagnoses. Lung cancer remains the leading cause of cancer death in the U.S. and worldwide, with the American Cancer Society projecting:

  • About 230,000 new diagnoses this year
  • About 125,000 deaths this year
  • A 1-in-19 lifetime risk of developing the disease

Side Effects Reported in the Daraxonrasib Trial

Nearly all participants experienced some side effect, and 54% had severe ones. The most common included:

  • Rash
  • Diarrhea
  • Nausea and vomiting
  • Mucositis (inflammation of the digestive tract lining)
  • Stomatitis (inflammation of the mouth lining)
  • Pneumonia
  • Low blood counts

Despite the frequency of side effects, researchers determined the safety profile was acceptable enough to justify moving forward with additional trials.

Path Toward FDA Approval for Non-Small Cell Lung Cancer Treatment

The FDA will likely require larger, late-stage clinical trials before evaluating daraxonrasib for a lung cancer indication. Key milestones so far:

Milestone

Date

Breakthrough Therapy designation granted

June 2025

FDA approval for pancreatic cancer

Last week (August 2026)

Phase 1 lung cancer results published

September 3, 2026

The drug’s pancreatic cancer approval moved through the Commissioner’s National Priority Voucher Program, a review pathway introduced by former FDA Commissioner Dr. Marty Makary that cut review time from 12 months to 10. The trial was funded by Revolution Medicines, the drug’s manufacturer.

How the Pancreatic Cancer Data Compares

Daraxonrasib’s track record in pancreatic cancer adds weight to the lung cancer findings. In a late-stage trial of 500 patients with metastatic pancreatic adenocarcinoma:

  • Median overall survival nearly doubled to more than 13 months
  • Standard chemotherapy patients saw a median survival of about 6.7 months

That survival data supported the drug’s approval for pancreatic cancer patients who had already tried at least one prior systemic therapy. A drug that changed outcomes in one difficult cancer now moving into trials for another suggests its RAS-targeting mechanism may have broader reach than first expected.

For now, the lung cancer results remain early-stage. Patients and physicians should expect a multi-year path through additional trials before any approval decision on daraxonrasib as a non-small cell lung cancer treatment.

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