A new oral drug, daraxonrasib, has been shown to nearly double survival in patients with advanced pancreatic cancer whose tumors had stopped responding to prior treatment, according to findings published in the New England Journal of Medicine and presented at the American Society for Clinical Oncology meeting. The drug targts a mutated protein present in over 90% of pancreatic cancer cases, offering a significant improvement over standard chemotherapy with fewer severe side effects.

Why 13.2 months vs. 6.7 months marks a turning point

In a trial of 500 patients with metastatic pancreatic cancer that had quit responding to prior treatment, those taking daraxonrasib lived for a median of 13.2 months compared with 6.7 months for chemotherapy recipients, according to the researchers.. The nearly doubled survival time is the first drug to show a substantial advantage over chemotherapy in this setting. the pills’ effects eventually wane, but recipients used them for significantly longer than the comparison group stayed on chemotherapy, reoprting less pain and a better quality of life as their tumors shrank.

The molecular glue that binds KRAS: How daraxonrasib works

Daraxonrasib blocks a mutated protein that fuels tumor growth in more than 90% of pancreatic cancer cases, the report says. The drug uses what is essentially a molecular glue to bind with multiple KRAS subtypes, a family of genes that normally regulates cell growth but has been notoriously hard to tackle compared with other cancers. Cancer specialists expressed optimism that this may be a turning point in the quest for new options, with dozens of experimental drugs in development targeting the same pathway.

What the FDA’s expedited review and expanded access mean for patients

The Food and Drug Administration plans to expedite review of daraxonrasib and is allowing what is called “expanded access” to the experimental drug for patients who meet certain criteria, according to the source. this means some patients can receive the drug before full approval, though it remains limited to those who qualify.. Researchers noted that many patients were still using the drug after the data was analyzed,suggesting the survival gap may widen as tracking continues .

Which KRAS subtypes respond best? The unanswered question

The source reports that researchers next will probe whether daraxonrasib worked better in certain KRAS subtypes, since the drug binds multiple subtypes. This open question is critical because pancreatic cancer is genetically diverse, and not all patients may benefit equally. Additionally, the researchers will explore the drug’s use earlier in the disease to see if tumor shrinkage might let more patients qualify for surgery — a potentially transformative step if successful.