A phase III clinical trial in which the Hospital Clínic de Barcelona has participated has shown that treatment with "daraxonrasib" manages to double overall survival in patients with metastatic pancreatic ductal adenocarcinoma, the most advanced stage of pancreatic cancer, who had already received previous lines of treatment.
The work, which is being announced this Sunday during the annual congress of the American Society of Clinical Oncology in Chicago (United States), indicates that patients who received the new drug achieved a median survival of 13.2 months, compared to the 6.7 months achieved with standard chemotherapy, as detailed to Europa Press by the head of the Medical Oncology Service at Clínic, Teresa Macarulla.
The specialist pointed out that this approach, unlike treatments available until now, acts directly on KRAS gene mutations, present in more than 90% of pancreatic tumors.
"The KRAS mutation is responsible for the tumor not responding to immunotherapy and for it being more aggressive. We have tried to block it for many years, and we had not succeeded because we could not fix the drugs," she stated.
"Daraxonrasib" is an oral tablet inhibitor that manages to block mutated variants of the RAS family and, at the same time, interrupt the signals that favor tumor growth.
A possible change in therapeutic paradigm
Macarulla advanced that this medication will allow "to change the therapeutic scenario" of pancreatic cancer and recalled that it is already being used in the United States, while in Europe it has not yet been incorporated into clinical practice due to the slower regulatory processes.
In US territory, the FDA has granted it "breakthrough designation," an accelerated approval procedure that facilitates "expanded use" of the drug before its full commercialization.
In the European case, between the authorization of the European Medicines Agency and that of the various national agencies, "it is not clear" what the definitive timeline will be, although Macarulla estimates that it could take between 1.5 and 2 years until its arrival.
Future research lines
The oncologist believes that these results constitute the "first stone," and that from now on the research effort will focus on exploring new combinations with this drug.
According to the current trial data, the first indication would be to administer it after a first chemotherapy regimen. Subsequent studies will need to clarify whether it can be used before, in combination with chemotherapy itself, or as adjuvant treatment to surgery.
Macarulla has added that the KRAS gene is also involved in some colon and lung cancers, although less frequently, so the role of this inhibitor could also be evaluated in these other types of tumors.