Pfizer Inc（PFE）資訊與事件PFEPfizer Inc

Pfizer Announces ELREXFIO Multiple Myeloma Study Results

Pfizer announced topline results from the Phase 3 MagnetisMM-32 study evaluating ELREXFIO as monotherapy in adults with relapsed or refractory multiple myeloma who received at least one prior line of treatment with anti-CD38 therapy and lenalidomide. At the pre-specified interim analysis for efficacy, the study met its primary endpoint of progression-free survival as assessed by blinded independent central review. ELREXFIO demonstrated a statistically significant and clinically meaningful reduction in the risk of disease progression or death versus investigator's choice of elotuzumab, pomalidomide and dexamethasone; pomalidomide, bortezomib and dexamethasone; or carfilzomib and dexamethasone. MagnetisMM-32 used one of the broadest standard-of-care comparators in a Phase 3 BCMA bispecific trial in this setting, with investigator's choice of three established regimens. More than 75% of patients receiving ELREXFIO had not experienced disease progression or death from any cause at the time of the analysis1, with an estimated 68% PFS at 18 months. Data for overall survival, a key secondary endpoint, remain immature, and follow-up will continue to the next pre-specified OS analysis. The safety profile of ELREXFIO in MagnetisMM-32 was consistent with its known profile and no new safety signals were identified. Infection prophylaxis measures instituted from the beginning of the study helped mitigate infection risk, including Grade 3 or higher infections. Grade greater than or equal to3 infections were observed in 27.5% of patients receiving ELREXFIO vs. 18.1% of patients on investigator's choice, and Grade 5 infections were observed in 0.8% of patients receiving ELREXFIO vs 1.6% of patients on investigator's choice. Pfizer plans to submit these data to global health authorities, with detailed results to be shared at a future medical meeting and submitted for publication.

Pfizer's TALZENNA and XTANDI Combo Approved by FDA for Prostate Cancer

Pfizer announced that the U.S. Food and Drug Administration has expanded approval of TALZENNA in combination with XTANDI to the treatment of men with metastatic androgen pathway modulation-naive or -sensitive prostate cancer with homologous recombination repair gene mutations, including both BRCA and non-BRCA mutations. mAPMN/S is also known as metastatic hormone-sensitive prostate cancer. This approval makes TALZENNA, an oral poly ADP-ribose polymerase, plus XTANDI, an androgen receptor pathway inhibitor, available in an earlier line, providing an opportunity to delay disease progression at a critical stage when more patients may experience greater benefit.