The Phase 3 trial results for daraxonrasib are now in print. Median overall survival in the treatment arm: 13.2 months. In the control arm: 6.7 months. The New England Journal of Medicine published the full data this week. [1]

That gap — 6.5 months — sounds modest until you place it in the context of what pancreatic cancer has historically done to survival curves. Pancreatic ductal adenocarcinoma, the most common form, has had a median overall survival measured in months for most patients diagnosed at late stage. Doubling that figure in a phase 3 trial for KRAS-mutated disease, which accounts for the majority of cases, is not an incremental result. It is the kind of number that changes how oncologists counsel patients at diagnosis.

The FDA has issued an expanded access determination that the trial is "safe to proceed," allowing patients outside the trial to access daraxonrasib on a compassionate use basis while full approval review continues. [2] The drug targets KRAS G12D mutations — a target that was considered "undruggable" for most of the past three decades. The Phase 3 result confirms that the target is druggable and that the clinical benefit is real.

What the data does not yet answer is durability. The 13.2-month median is a central tendency, not a ceiling. How many patients exceeded 18 months, 24 months, or longer, and what distinguished their tumors, remains the open question the trial's long-term follow-up data will need to address.

The number that matters right now is the 6.5-month gap. For a disease where gains have historically been measured in weeks, that gap is the story.

-- KENJI NAKAMURA, Tokyo