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biotech/news//Free Malaysia Today
The drug targets KRAS, a gene mutation found in more than 90% of pancreatic cancer cases.
Daraxonrasib cut death risk by 60% in metastatic pancreatic cancer patients with certain KRAS mutations.
KEY POINTS
Patients taking daraxonrasib survived a median of 13.2 months versus 6.6 months with chemotherapy.
The FDA is expected to fast-track daraxonrasib and may allow pre-approval access for eligible patients.
Daraxonrasib delayed disease progression longer and caused fewer treatment discontinuations due to side effects.
Researchers are expanding trials of daraxonrasib to earlier treatment stages and other RAS-mutant cancers.
According to Newsweek, the experimental drug daraxonrasib received a standing ovation lasting nearly a minute when its phase-3 trial results were presented at the American Society of Clinical Oncology (Asco) annual meeting in Chicago on May 31.
The drug targets KRAS, a gene mutation found in more than 90% of pancreatic cancer cases. The findings were presented by Dr Brian M Wolpin, director of the Hale Family Center for Pancreatic Cancer Research.
When data showing a 60% reduction in the risk of death among certain patients appeared on screen, oncologists in the packed auditorium reportedly responded with applause, cheers and whistles.
“That time was not built into my talk,” Wolpin joked after the ovation subsided.
For decades, scientists struggled to develop treatments capable of effectively targeting the protein produced by the gene. Several cancer specialists described the results as a landmark moment.
Asco chief medical officer Dr Julie Gralow described the findings as “much more than a home run”, telling reporters: “I would actually say it’s a grand slam.”
Dr Mark Lewis, a director of gastrointestinal oncology, wrote on X that it felt as though “RAS targeting has arrived”; while Dr Rachna Shroff, chief of hematology and oncology at the University of Arizona Cancer Center, called it “a game changer”.
“Having treated pancreatic cancer for 16 years, I actually started crying in clinic. This is such an incredibly impactful study for our patients,” she said.
Pancreatic cancer remains one of the deadliest cancers worldwide. In the United States alone, it claims about 50,000 lives annually, while patients with metastatic disease face particularly poor survival rates.
The drug, developed by California-based Revolution Medicines, is a once-daily pill that belongs to a new class of treatments designed to switch off active RAS proteins that drive tumour growth.
The Phase-3 RASolute 302 trial involved 500 patients with metastatic pancreatic cancer whose disease had progressed despite previous treatment. Participants received either a daily oral dose of daraxonrasib or standard chemotherapy.
According to results published simultaneously in the New England Journal of Medicine, patients with specific KRAS mutations survived a median of 13.2 months on daraxonrasib, compared with 6.6 months for those receiving chemotherapy.
The drug also delayed disease progression for longer periods and was associated with fewer treatment discontinuations caused by side effects.
Following the trial results, the US Food and Drug Administration is expected to fast-track its review of daraxonrasib, which has already received special designations for promising treatments targeting rare and serious diseases.
Regulators have also authorised a programme that could allow eligible patients with previously treated metastatic pancreatic cancer to receive the drug before formal approval, Newsweek reported.
The researchers are now studying daraxonrasib in earlier stages of treatment and in other cancers linked to RAS mutations, including lung, colon and ovarian cancers.
While further studies will determine its long-term impact, many specialists believe the drug could represent one of the most significant advances in pancreatic cancer treatment in recent decades.
Notably, daraxonrasib is not the only drug generating excitement among pancreatic cancer specialists.
Earlier this year, Malaysian doctor Devalingam Mahalingam led a clinical trial in Chicago that found the experimental drug elraglusib doubled one-year survival rates when added to standard chemotherapy for advanced pancreatic cancer.
Researchers are also pursuing a larger study to confirm those findings, raising hopes that multiple new treatment approaches may finally be gaining ground against one of the deadliest forms of cancer.