HQ Team
June 16, 2024: Pfizer Inc.,’s investigational drug for blood cancer, Elrexfio, has shown an overall survival rate of 24.6 months in a single-arm trial, according to a statement.
The experimental drug administered to a sample of individuals with replaced or multiple myeloma was followed over time to observe their response.
Multiple myeloma is an incurable blood cancer that affects plasma cells made in the bone marrow.
During the mid-stage trials, the median progression-free survival (PFS) was 17.2 months. “For patients with CR or better response, the median PFS was not reached, and at two years, the estimated PFS rate was 90.6%,” according to a statement from Pfizer.
Accelerated approval
“These compelling overall survival data support the clinical benefit Elrexfio has already demonstrated and its potential to be a transformative treatment option for people with multiple myeloma,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer.
The latest results from the study “reinforce the very promising efficacy observed with Elrexfio in a relapsed or refractory setting, with deep and durable responses,” he said.
The US Food and Drug Administration gave Pfizer an accelerated approval in August 2023 for the treatment of adult patients with the disease who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
“Continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial,” according to the company statement.
In December 2023, the European Commission granted conditional marketing authorization for the therapy for the treatment of adult patients with RRMM who have received at least three prior therapies.
Duration of response
The primary endpoint of the investigation is the objective response rate as assessed by Blinded Independent Central Review.
Key secondary endpoints include duration of response, progression-free survival, minimal residual disease negativity rate, overall survival, and safety.
“People with relapsed or refractory multiple myeloma often have limited therapeutic options as their disease progresses due to treatment resistance, resulting in increasingly shorter remission and duration of response,” said Mohamad Mohty, the clinical trial investigator and Prof of Hematology and Head of the Hematology and Cellular Therapy Department at the Saint-Antoine Hospital and Sorbonne University, Paris, France.
“These impactful overall survival data are particularly encouraging given the very advanced patient population with characteristics associated with poorer outcomes.”
The data from the study will be presented during a poster session at the European Hematology Association Hybrid Congress in Madrid, Spain, from June 13-16. Additional presentations will highlight Elrexfio data across the comprehensive clinical trial program.
