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Trial resultsApr 29, 2026181 days ago

ELREXFIO MagnetisMM-5 Ph3 met primary endpoint of PFS in relapsed/refractory multiple myeloma

Pfizer reported results from its Phase 3 study of ELREXFIO (elranatamab) for Double-class exposed relapsed/refractory multiple myeloma (MagnetisMM-5) on Apr 29, 2026. The study met its main goal.

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DetailsClinical trial results · also called: readout / topline data
Company
Pfizer Inc. PFE
Drug
ELREXFIO (elranatamab)
For
Double-class exposed relapsed/refractory multiple myeloma (MagnetisMM-5)
Stage
Phase 3 · the last stage before a drug can be approved
When
Apr 29, 2026
Source note
Listed on Pfizer's 'Key Anticipated 2026 Catalysts' pipeline page (company guidance; year-level timing only). Pfizer's Aug 4, 2026 Q2 release headlines 'Several Key Pivotal Readouts Expected Over Next 12 Months'.
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Pfizer Inc.
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Pfizer expects to report results from its Phase 3 study of mevrometostat (PF-06821497) for 1-2L metastatic castration-resistant prostate cancer post-abiraterone (MEVPRO-1) during 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.

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Entry
Mevrometostat MEVPRO-1 Ph3 mCRPC readout · Clinical trial results (readout / topline data)
Drug
mevrometostat (PF-06821497)
For
1-2L metastatic castration-resistant prostate cancer post-abiraterone (MEVPRO-1)
Stage
Phase 3 · the last stage before a drug can be approved
When
2026 · the company gave a window, not a day
Source note
Listed on Pfizer's 'Key Anticipated 2026 Catalysts' page under anticipated data readouts (year-level timing).
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MilestonePFEPfizer2026

Berobenatide (PF-3944) 10 Phase 3 obesity studies to start in 2026, expected during 2026 (no exact date yet). A company milestone for Pfizer (berobenatide (PF'3944) for Chronic weight management and obesity comorbidities (knee OA, OSA)): a step in the program rather than a decision or a data readout.

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Entry
Berobenatide (PF-3944) 10 Phase 3 obesity studies to start in 2026 · Company milestone
Drug
berobenatide (PF'3944)
For
Chronic weight management and obesity comorbidities (knee OA, OSA)
Stage
Phase 3 · the last stage before a drug can be approved
When
2026 · the company gave a window, not a day
Source note
Pfizer Q2 2026 earnings release (Aug 4, 2026), following June 2026 VESPER-1/2/3 Phase 2b data for the monthly GLP-1 RA peptide; part of a 20+ trial obesity program.
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MilestonePFEPfizer2026

PD-1xVEGF (PF'4404) pivotal study starts incl. 1L NSCLC, expected during 2026 (no exact date yet). A company milestone for Pfizer (PF-08634404 (PD-1xVEGF bispecific) for 1L squamous/non-squamous NSCLC and other tumors): a step in the program rather than a decision or a data readout.

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Entry
PD-1xVEGF (PF'4404) pivotal study starts incl. 1L NSCLC · Company milestone
Drug
PF-08634404 (PD-1xVEGF bispecific)
For
1L squamous/non-squamous NSCLC and other tumors
Stage
Phase 3 · the last stage before a drug can be approved
When
2026 · the company gave a window, not a day
Source note
Pfizer's 'Key Anticipated 2026 Catalysts' page lists pivotal study starts for the PD-1xVEGF bispectific in 2026 (also PD-1xVEGF + PADCEV in 1L mUC); year-level timing only.
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FDA decisionPFEPfizerQ4 2026

The FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve Pfizer’s TALZENNA (talazoparib) + XTANDI (enzalutamide) for HRR gene-altered metastatic castration-sensitive prostate cancer. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.

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Entry
PDUFA for TALZENNA + XTANDI in HRR-mutated mCSPC · FDA decision due (PDUFA date)
Drug
TALZENNA (talazoparib) + XTANDI (enzalutamide)
For
HRR gene-altered metastatic castration-sensitive prostate cancer
Stage
sNDA under Priority Review
When
Q4 2026 · the company gave a window, not a day
Source note
FDA granted Priority Review to the sNDA based on Phase 3 TALAPRO-3 (52% reduction in risk of radiographic progression or death). Pfizer's release states a PDUFA action date in the last quarter of 2026; no exact day disclosed.
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FDA decisionPFEPfizerQ4 2026

The FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve Pfizer’s TUKYSA (tucatinib) + trastuzumab + pertuzumab for HER2-positive metastatic breast cancer. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.

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Entry
Estimated PDUFA for TUKYSA combination in HER2+ metastatic breast cancer · FDA decision due (PDUFA date)
Drug
TUKYSA (tucatinib) + trastuzumab + pertuzumab
For
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Stage
Supplemental application
When
Q4 2026 · the company gave a window, not a day
Source note
Catalyst tracker pdufa.bio lists a Q4 2026 (estimated) FDA action date for the TUKYSA combination in HER2+ MBC. No Pfizer press release stating the date was located, so treated as an estimate.
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MilestonePFEPfizerQ4 2026

35-valent pneumococcal vaccine adult candidate to enter clinic by end of 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Pfizer (PCV35 (fifth-generation pneumococcal conjugate vaccine) for Pneumococcal disease, adults): a step in the program rather than a decision or a data readout.

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Entry
35-valent pneumococcal vaccine adult candidate to enter clinic by end of 2026 · Company milestone
Drug
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For
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Stage
Phase 1 · an early safety study in a small group of people
When
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Source note
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