Pfizer's ELREXFIO Wins Late-Stage Multiple Myeloma Trial; Lorlatinib Study Completed
Pfizer's ELREXFIO significantly delayed disease progression in a Phase 3 trial for multiple myeloma, outperforming a standard regimen and strengthening the case for earlier use. Separately, Pfizer completed a real-world study of its lung cancer drug lorlatinib in ROS1-positive NSCLC patients.
Pharma giant Pfizer says its experimental cancer therapy ELREXFIO has delivered a major win in a pivotal late-stage trial, significantly delaying disease progression in patients with hard-to-treat multiple myeloma. The Phase 3 MagnetisMM-5 study showed the drug, used alone, outperformed a widely used standard treatment regimen in patients whose cancer had returned or stopped responding to prior therapies. The key measure—progression-free survival—improved by a statistically significant and clinically meaningful margin, according to the company.
Patients receiving ELREXFIO largely remained free from disease progression during the interim analysis, surpassing expectations set for the trial. Safety results were in line with what doctors have seen before, with no new concerns emerging. The trial is still ongoing, with researchers continuing to track overall survival—a crucial benchmark that has not yet matured. Pfizer plans to present detailed findings at a future medical meeting and share the data with regulators worldwide.
“Effective intervention earlier in the course of disease represents a critical opportunity to improve outcomes for people living with multiple myeloma,” said the Chief Oncology Officer of Pfizer. “ELREXFIO has already helped address a significant unmet need in heavily pre-treated patients, delivering deep, durable, and clinically meaningful responses. The MagnetisMM-5 results reinforce our confidence in ELREXFIO’s potential to benefit patients earlier in their treatment journey and support our comprehensive strategy to evaluate ELREXFIO both as monotherapy and as part of combination approaches across multiple lines of therapy.”
ELREXFIO is already cleared for use in more than 35 countries, including the United States and the European Union, for patients who have undergone multiple prior treatments. Multiple myeloma, an aggressive and incurable blood cancer, is the second most common blood cancer. The MagnetisMM-5 trial is part of a broader development push targeting patients exposed to multiple drug classes, including another ongoing Phase 3 study examining the therapy in earlier treatment settings.
In a separate development, Pfizer has completed a study looking at real-world use of its lung cancer drug lorlatinib in patients with advanced non small cell lung cancer that has spread. The study, titled “A Retrospective Study to Evaluate the Real-World Effectiveness of Lorlatinib Among ROS1-Positive NSCLC Patients,” aims to show how the drug performs outside controlled trials. Lorlatinib is an oral tablet taken at home. It targets a specific gene change, ROS1, and is used after at least one prior cancer therapy has failed. The study is observational rather than a classic randomized trial. All patients already received lorlatinib as part of usual care, and researchers looked back at their records in a cohort design. There was no control arm or blinding, so the core goal was to describe outcomes and safety in routine practice, not to directly compare lorlatinib with a rival drug.
The study was first submitted on 5 November 2024, signaling when Pfizer put the protocol on record. The latest update was filed on 8 July 2026, marking completion and data refresh. Results had not yet been formally posted at that time, but the “completed” status confirms that follow-up is done and the dataset is ready for analysis.