Resultados finals from the RASoute 302 study were presented at the American Society of Clinical Oncology plenary session. Daraxonrasib, an oral tablet, nearly doubled the median survival of previously treated metastatic pancreatic cancer patients. The audience stood up to applaud. Alguns doctors cried.
The phase 3 randomized clinical trial involved 500 patients. Eles were divided into two groups. One received daraxonrasib. The other continued with conventional chemotherapy. The medicine is developed by Revolution Medicines. The data were considered definitive.
Resultados shows 6.6 month gain in median survival
In the group with RAS G12 mutation, median survival reached 13.2 months with daraxonrasib. With chemotherapy, it took 6.6 months. The difference was 6.6 months. The risk of death fell by 60%.
The numbers were repeated in the general analysis of the study population. Median survival was 13.2 months versus 6.7 months. The time without disease progression also doubled. Foram 7.3 months versus 3.5 months in the RAS G12 mutation group.
Médicos present highlighted the consistency of the findings. The side effect profile was favorable. Apenas 1.2% of patients needed to stop treatment due to toxicity. In chemotherapy, the rate was 11.2%.
- Sobrevida median 13.2 months with daraxonrasib versus 6.6-6.7 months with chemotherapy
- Redução 60% risk of death
- Tempo until progression doubled to 7.3 months
- Resposta targets tumor in 31% of cases with new drug
- Baixa discontinuation rate due to side effects
Câncer of pancreas has a serious prognosis in most cases
The disease is usually diagnosed at an advanced stage. Cerca 80% of cases are already metastatic at the time of diagnosis. No Brasil, there are around 13 thousand new cases per year. Quase 12 thousand patients die in the same period.
The mutated RAS protein is present in more than 90% of pancreatic tumors. Ela acts as a non-off switch. For decades, it was considered “undruggable.” Daraxonrasib was able to block several variants of the mutation at the same time.
Pesquisadores followed patients for a median of 8.5 months. The results were published in Journal of Clinical Oncology. The conclusion was clear. The drug should become the new standard for second line treatment.
Oncologistas highlight impact of findings at ASCO session
Stephen Stefani, Americas Health Foundation oncologist, followed the presentation. Ele reported the excitement in the auditorium. Raramente sees this celebration for a new treatment against this disease.
The expert recalled that the study used the most rigorous design possible. Randomização, control and complete final analysis. Mais than 30% of patients had measurable tumor shrinkage. Para many, this meant additional months of quality life.
Outros researchers present reinforced the point. The novel mechanism and low toxicity make daraxonrasib a viable option. Até Now, options were limited after initial chemotherapy failed.
Próximos steps involve regulatory approval on Estados Unidos
Revolution Medicines plans to submit the data to the FDA. The drug already has Breakthrough Therapy status. Isso speeds up analysis. Também has received orphan drug designation.
No Brasil, the path is longer. Anvisa would need to start its own process. Planos health system and the public system would have to evaluate coverage. The current cost of advanced oncology treatments is high.
Especialistas follows the development. Compassionate access already exists in some cases on Estados Unidos. Para patients without options, the pill represents concrete hope.
Entusiasmo marks historic change in the treatment of the disease
Pancreatic cancer remains one of the deadliest. Sobrevida in five years for metastatic form is around 3%. Avanços like this are rare.
Daraxonrasib acts directly on the RAS pathway. Ele is taken once daily. Isso contrasts with intravenous chemotherapy sessions. Tolerability was one of the most praised points.
The presentation at ASCO consolidated what preliminary data already indicated. The oncology community is now discussing how to incorporate the treatment into clinical practice. Additional Estudos may explore future combinations.
The final result confirms that the pill changed the scenario for second-line patients. From a short prognosis, we move to a longer time window. Isso changes discussions about quality of life and care planning.
Médicos who treat the disease daily saw the numbers on the screen. The reaction was immediate. Aplausos and tears marked the moment. Para many patients and families, the data represents something that seemed distant: real progress.