Rome, March 15 (beraking latest news Salute) – Data from the Amgen Phase III study on blinatumomab published in Journal of the American Medical Association (Jama). This study evaluated the efficacy, safety and tolerability of Blincyto * (blinatumomab) versus consolidation chemotherapy prior to allogeneic haematopoietic stem cell transplantation in pediatric patients with B-cell precursor acute lymphoblastic leukemia (Lla) who developed a first relapse of high-risk disease.
Blinatumomab demonstrated a longer disease-free survival than chemotherapy. In fact, after nearly 2 years, 69% of patients treated with blinatumomab were alive and event-free compared with 43% of patients treated with chemotherapy. In addition, among the patients who had a residual tumor cell at the start of the study, potentially capable of giving rise to disease recurrence (minimal residual disease or Mrd), 93% reached the state of negativity at Mrd after the treatment with blinatumomab, compared with 24% of patients treated with chemotherapy. The three-year OS estimate in the blinatumomab group was 81% versus 56% in the chemotherapy group.
“Acute lymphoblastic leukemia is the most common childhood cancer. Unfortunately, about 15% of young patients with B-cell precursor acute lymphoblastic leukemia relapse after a first line of chemotherapy,” said David M. Reese. , Executive Vice President of Research and Development at Amgen. “We need new treatment options for these patients: the study results support the use of blinatumomab as a new standard of pre-transplant consolidation therapy for patients experiencing first relapse with high-risk prognostic connotations.”
In the group treated with blinatumomab – Amgen again reports in a note – the incidence of serious adverse events was 24.1%, compared to 43.1% in the group treated with chemotherapy. And no fatal adverse events were reported. “I am very satisfied that the results of the randomized study demonstrated the greater efficacy of blinatumomab compared to intensive chemotherapy as well as a lower incidence of serious toxicities,” said Franco Locatelli, director of the Department of Onco-hematology and Cell and Gene Therapy, Irccs Bambino Gesù pediatric hospital in Rome, Professor of Pediatrics at the Sapienza University of Rome and coordinator of the European Phase III study on blinatumomab, which in Italy involved about 50 young patients in 8 centers.
“Chemotherapy – underlined Locatelli – has so far been used as a primary consolidation treatment for all patients with Lla in first disease relapse with high-risk characteristics before stem cell transplantation: an approach that is only partially effective and associated major toxicity. Blinatumomab has been shown to be a safer and more effective consolidation therapy option for pediatric patients with early high-risk relapse B-cell precursor acute lymphoblastic leukemia and today we have one more therapeutic tool to heal this subgroup of children “.
Treatment of Mrd is crucial for preventing future disease relapses in patients in complete remission. Blinatumomab is the first and only therapy to have received regulatory approval globally for the treatment of patients with Mrd. The US and European studies confirm the same data on Jama. In addition, the results of the American Phase 3 study by the Children’s Oncology Group (Cog) in which children, adolescents and young adults (up to the age of 30) with B-cell precursor acute lymphoblastic leukemia at first relapse were treated with blinatumomab or chemotherapy before undergoing an allogeneic stem cell transplant. In this study, too, the treatment demonstrated a better chance of event-free survival, a reduction in severe toxicities, a higher rate of negativization of Mrd, a greater probability of allogeneic haematopoietic stem cell transplantation and a better overall survival than to chemotherapy.