Golden Biotechnology has shared updated data on its mushroom-derived drug candidate in metastatic pancreatic cancer, linking first-line use of the molecule to median overall survival (OS) of 14.1 months.
People with metastatic pancreatic cancer lack good options, to the extent that the National Institutes of Health recommends that all newly diagnosed patients should consider enrolling in clinical trials. Chemotherapy remains the least bad option for many patients, with the FOLFIRINOX cocktail and gemcitabine-nab-paclitaxel combination respectively chalking up median OS figures of 11.1 months and 8.5 months. Another chemotherapy regimen, NALIRIFOX, also achieved a median OS of 11.1 months last year.
Golden Biotech is presenting data on its attempt to clear that OS bar at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium this week. The median OS in metastatic pancreatic cancer patients who received its drug antroquinonol, along with gemcitabine and nab-paclitaxel as a first-line treatment was 14.1 months. Median progression-free survival clocked in at 5.3 months.
The OS has increased since an earlier look at the data, when it came in at 12.6 months. In 2014, an ASCO committee said a 4-5 month improvement over FOLFIRINOX, or 3-4 month edge over gemcitabine-nab-paclitaxel, would be clinically meaningful. Research suggests more patients are eligible for gemcitabine-nab-paclitaxel than the more effective FOLFIRINOX.
In the absence of a control arm, it is impossible to tell whether adding antroquinonol to the treatment mix improves on the OS achieved by chemotherapy. Investors appeared unmoved, with little change in the Taiwanese biotech’s share price on the Taipei Exchange.
Golden Biotech’s statement lacks a close look at the safety and tolerability results. An earlier cut of the data showed the rates of neutropenia, thrombocytopenia and anemia were lower in the antroquinonol group than in an earlier chemotherapy trial, although the rates of vomiting and diarrhea were higher.
Antroquinonol is a ubiquinone derivative found in a mushroom that grows on a tree of Taiwan. Evidence that the molecule blocks RAS signaling has spurred Golden Biotech to advance the molecule in pancreatic cancer. Other biotechs are going after the cancer by targeting KRAS, NTRK fusions, RET and other drivers of pancreatic tumors.