Janssen's Talvey Plus Darzalex Faspro Combination Reduces Risk of Disease Progression by 72% and Death by 53% in Phase 3 MonumenTAL-3 Study Presented at EHA 2026

Jun 14, 2026 11:09 CST Updated 11:09

Johnson & Johnson

Medical Device R&D and Manufacturer

On June 13, local time in Stockholm, at the plenary session of the 2026 European Hematology Association (EHA) Annual Congress, Johnson & Johnson presentedMonumenTAL-3 Phase III Study Reports Major Positive ResultsPublished online simultaneously in the New England Journal of Medicine (NEJM), this study marks another milestone in the field of multiple myeloma treatment.

This isFirst Global Confirmation of the Superiority of Progression-Free Survival (PFS) with GPRC5D Bispecific Antibody Combination Regimens in Earlier-Line Multiple Myeloma TreatmentPhase III clinical study further solidifies Johnson & Johnson's leading position in the field of hematologic oncology.

Core Data: 72% Reduction in Risk of Progression, 53% Reduction in Risk of Death

The MonumenTAL-3 study investigated Johnson & Johnson’s GPRC5D-directed bispecific antibody in patients with relapsed/refractory multiple myeloma who had received at least one prior line of therapy.TalveyEfficacy of Darzalex Faspro (subcutaneous daratumumab), divided into two trial groups:

DT Group：Talvey + Darzalex Faspro
DTP Group: Talvey + Darzalex Faspro + Pomalidomide
Control Group: Standard regimen DPd (Darzalex Faspro + pomalidomide + dexamethasone)

? Key Efficacy Data (24-Month Follow-Up)

Core Conclusions: Regardless of whether combined with pomalidomide, the Talvey + Darzalex dual-drug combination demonstrated statistically and clinically significant benefits, with all secondary endpoints (including overall response rate, minimal residual disease [MRD], etc.) also showing statistically significant improvements.

Strategic Significance: Frontline Advancement of Bispecific Antibody Regimens Across All Lines, Reshaping the Treatment Landscape

“The results of the MonumenTAL-3 study underscore our commitment to advancing bispecific antibody combination regimens into earlier lines of therapy, building on the strength and breadth of Johnson & Johnson’s multiple myeloma portfolio,” said Dr. Yusri Elsayed, Global Head of Oncology at Johnson & Johnson. “These findings enrich our body of evidence in the field of bispecific antibodies and reinforce our strategy to advance differentiated immunotherapies—matching the right treatment with the right patient at every stage of the disease.”

? The Three Major Milestone Significances of This Study:

First GPRC5D Bispecific Antibody Breakthrough in the Frontline Setting

This marks the first time a GPRC5D-targeted bispecific antibody has demonstrated superior progression-free survival (PFS) in earlier-line treatment.

Talvey, as the first globally approved GPRC5D-targeted therapy, has successfully advanced from last-line treatment to earlier lines of therapy.

Chemotherapy-Free Regimens Become a Reality

The DT group (Talvey + Darzalex) achieved a 24-month PFS rate of 77.6% without the use of chemotherapy agents.

Provides an efficient and safe chemotherapy-free option for patients intolerant to chemotherapy

Johnson & Johnson’s Bispecific Antibody Pipeline Achieves Dual Success

In March this year, another BCMA bispecific antibody from Johnson & JohnsonTecvayli+DarzalexRecently FDA-approved for patients who have received at least one prior line of therapy

The regimen earned accelerated approval from the FDA, which proactively granted it a “Priority Review Voucher” (CNPV), based on impressive data demonstrating a 54% reduction in mortality risk.

Business Landscape: Targeting a $50 Billion Oncology Sales Goal

Johnson & Johnson’s portfolio in the field of multiple myeloma has formed a comprehensive ecosystem:

? Core Product Portfolio

Darzalex (daratumumab): 2025 Sales Revenue$14 billion, cornerstone therapies for multiple myeloma, covering the full spectrum of treatment
Tecvayli (BCMA Bispecific Antibody): 2025 Sales Revenue$670 million, the first approved BCMA bispecific antibody, recently completed the expansion of its frontline indications and received approval for a biweekly dosing regimen
Talvey (GPRC5D Bispecific Antibody): 2025 Sales Revenue$463 million, the world’s first GPRC5D-targeted therapy, is rapidly catching up

? Strategic Ambition

Johnson & Johnson explicitly stated:By 2030, have corresponding treatment regimens available for each line of therapy in multiple myeloma., becoming the "only pharmaceutical company with a full-spectrum product portfolio."

Darzalex and its subcutaneous formulation, Darzalex Faspro, are Johnson & Johnson’s$50 Billion in Oncology Business Sales by 2030Core pillars of the strategy. Furthermore, the expansion of front-line indications for the two bispecific antibodies, Tecvayli and Talvey, will inject strong growth momentum into this objective.

Industry Watch: The Era of Bispecific Antibodies Has Fully Arrived

Johnson & Johnson’s series of successes marks the official entry of multiple myeloma intoA New Era of Dual Antibody Therapy：

From the Rear to the Frontline: Bispecific antibodies are no longer limited to last-line salvage therapy; they are becoming a core component of standard treatment.

From Monotherapy to Combination Therapy: The "dual immunotherapy combination" regimen with CD38 monoclonal antibodies demonstrates significant potential for synergistic enhancement.

From Chemotherapy to Chemotherapy-Free: Highly effective immune combination regimens are gradually replacing traditional chemotherapy

For domestic pharmaceutical companies, Johnson & Johnson’s successful pathway also offers clear lessons: differentiated target selection for bispecific antibodies, combination strategies with cornerstone drugs, and steady advancement from later-line to earlier-line therapies are key elements of success.

Currently, Johnson & Johnson has submitted label expansion applications to regulatory authorities worldwide, committed to "bringing this treatment regimen to eligible patients as soon as possible." It is foreseeable that as both Talvey and Tecvayli enter earlier lines of therapy, Johnson & Johnson's leading advantage in the multiple myeloma field will further expand.

Summary

At a time when CAR-T therapy is in the spotlight, Johnson & Johnson’s consecutive successes with bispecific antibodies have demonstrated that there are no absolute advantages or disadvantages to any technical route—only differences in clinical value. Leveraging their convenience, accessibility, and potential for combination therapies, bispecific antibodies are reshaping the treatment paradigm for hematologic malignancies.

What is more thought-provoking is that Johnson & Johnson’s sustained leadership has never relied on breakthroughs in single products, but rather on its systematic capability to cultivate a specific disease area for decades and build a comprehensive product ecosystem. This, perhaps, is what Chinese pharmaceutical companies should truly learn from.

References:

https://www.fiercepharma.com/pharma/eha-jj-sharpens-myeloma-edge-talvey-darzalex-faspro-combo-proves-its-worth-earlier-disease