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Pfizer said its multiple myeloma medicine Elrexfio outperformed established treatment combinations in a late-stage trial involving patients whose cancer had returned or stopped responding after common earlier therapies, a result the company plans to submit to regulators.
The October 27 company announcement said the Phase 3 MagnetisMM-32 study met its main goal of improving progression-free survival, the length of time patients remain alive without their disease worsening. The finding was assessed by a blinded independent review.
This is a trial announcement, not a new U.S. approval. Pfizer said Elrexfio currently has accelerated approval in the United States for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. The new study tested an earlier treatment setting, after at least one prior line that included anti-CD38 therapy and lenalidomide.
What the trial measured
According to Pfizer, the randomized study enrolled 523 adults across 26 countries. Patients received either Elrexfio alone or one of three established treatment combinations chosen by their investigator. Those alternatives paired elotuzumab, pomalidomide and dexamethasone; pomalidomide, bortezomib and dexamethasone; or carfilzomib and dexamethasone.
Pfizer said Elrexfio produced a statistically significant and clinically meaningful reduction in the risk of disease progression or death compared with that control group. The announcement did not provide a numerical hazard ratio or the percentage reduction in that risk, so the size of the comparative benefit cannot yet be stated from this release.
The company reported an estimated progression-free survival rate of 68% at 18 months for Elrexfio. It also said more than 75% of patients receiving the drug had not experienced progression or death at the analysis cutoff. Those figures describe different views of the data: the 18-month estimate accounts for follow-up over time, while the cutoff figure describes events observed by the analysis date.
Median progression-free survival had not yet been reached, Pfizer said. That does not mean the cancer was cured. It means the study had not observed enough progression or death events in that group to identify the midpoint of that measure.
Survival and safety still need watching
Overall survival, a separate measure of how long patients live, remains immature, according to Pfizer. Follow-up will continue to a planned later analysis. A progression-free survival result should therefore not be described as proof that the drug helps these patients live longer overall.
The company said the safety findings were consistent with Elrexfio’s known profile, with no new safety signals. That does not mean the treatment was free of serious risks. Grade 3 or higher infections occurred in 27.5% of patients receiving Elrexfio, compared with 18.1% in the investigator-choice group. Grade 5 infections, which are fatal, occurred in 0.8% and 1.6%, respectively, Pfizer reported.
Pfizer’s U.S. safety information warns of serious or life-threatening cytokine release syndrome and neurological problems. Elrexfio is an antibody treatment designed to connect a target on myeloma cells with T cells, part of the body’s immune defenses. Its treatment and monitoring requirements matter alongside its ability to control disease.
What happens next
Patients in the Elrexfio group received injections under the skin, beginning with two step-up doses and then weekly dosing, with later transitions to every two weeks and monthly dosing, according to the company. The trial’s schedule is not a recommendation to use the medicine outside its approved indication.
Pfizer said it plans to submit the results to health authorities globally, present detailed findings at a medical meeting and seek publication. Those next steps should provide more information about the comparative benefit, follow-up and safety trade-offs. For now, the announced result supports Pfizer’s effort to move the treatment earlier in care, while any change in approved use remains a regulatory decision.
JBizNews Desk | New York
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