Europe gives the green light to the drug that increases life expectancy in pancreatic cancer. The European Medicines Agency (EMA) recommends marketing authorization for daraxonrasib (Rasonque), a daily pill to stop metastatic pancreatic adenocarcinoma. In the US, it was approved on a fast track basis last August, due to its proven benefits.
Patients treated with daraxonrasib enjoyed a median survival of 12.4 months, compared to 6.7 months for those who received chemotherapy. Additionally, the length of time patients lived without their disease getting worse was 7.2 months with the pill, compared to 3.6 months with chemo. The most frequently reported side effects were diarrhea, rash, stomatitis (inflammation of the oral mucosa), nausea, and vomiting.
This drug is aimed at patients with metastatic pancreatic adenocarcinoma whose disease has worsened after previous treatment, have limited therapeutic options and have a poor prognosis. Given the severity of the disease, limited efficacy, and considerable toxicity of standard chemotherapy, there is a need for better treatment options for these patients.
In Europe, there are an estimated 79,000 to 146,000 new cases of pancreatic cancer annually in total, of which approximately 50% to 52% are diagnosed at the metastatic stage (at the time of initial detection or due to advanced spread). In our country, there are almost 10,000 detections a year. Less than 20% of patients are susceptible to surgery at the time of diagnosis, given the advanced stage of the disease. After surgery, survival is usually between 10 and 20 months.
The secret of the drug against the key gene for pancreatic cancer
Daraxonrasib was evaluated in a multinational, phase 3, open-label study involving 500 patients with metastatic pancreatic adenocarcinoma whose disease had worsened after prior systemic (whole-body) treatment. Of these patients, 92 had a confirmed RAS G12 mutation, which includes the most common RAS mutations associated with this disease.
Our country participated from four hospitals (the University of Navarra Clinic, the 12 de Octubre Hospital in Madrid, the Vall d'Hebron Hospital in Barcelona and the Valencia Clinic) which allowed around twenty Spanish patients to test the benefits of this treatment.
Mutation of the RAS pathway means that the therapy is aimed at cutting off any type of communication of the tumor cell with the environment that provides it with nutritional supplies. "Unlike first-generation inhibitors that only attacked very specific mutations (such as KRAS G12C, rare in the pancreas), daraxonrasib acts broadly against any mutation of the RAS pathway," Mariano Ponz, oncologist in the Liver and Pancreas Cancer Area of the Cancer Center Clínica Universidad de Navarra (CUN), detailed to this medium in a recent report with a patient who had benefited from the therapies through clinical trials. "This allows it to go from benefiting 2-3% of patients to covering 90-95% of patients with pancreatic cancer," he added.
In May, at the world medical oncology event held in Chicago (ASCO), the latest data were presented with simultaneous publication in The New England Journal of Medicine: in patients pretreated with standard chemotherapy, the drug doubled overall survival, going from a median of six months to prolonged survival. In previous studies, an overall survival of 14.5 months and 7.6 free of tumor progression were recorded.
An emergency approval for clinical necessity
The EMA recommendation is the result of a staged assessment of the data on daraxonrasib, a drug identified under the EMA's Cancer Medicines Pathfinder project as a high-priority medicine capable of addressing this unmet medical need.
