TECVAYLI's Landmark Phase 3 Trial Delivers 71% Disease Progression Risk Cut in Multiple Myeloma Treatment

Johnson & Johnson’s investigational biologic therapy TECVAYLI (teclistamab-cqyv) has achieved significant clinical milestones in addressing one of oncology’s most challenging conditions. The positive Phase 3 MajesTEC-9 results reveal a compelling efficacy profile for patients battling multiple myeloma, particularly those who have exhausted conventional treatment pathways.

Clinical Breakthrough: Superior Survival Outcomes

The Phase 3 MajesTEC-9 study demonstrates TECVAYLI’s ability to substantially lower disease progression and mortality risks. The monotherapy approach achieved a 71% reduction in the risk of disease progression or death, while simultaneously cutting mortality risk by 40% among patients predominantly resistant to anti-CD38 therapy and lenalidomide. These outcomes position TECVAYLI as capable of delivering improved progression-free survival (PFS) and overall survival (OS) metrics compared to current treatment standards, even as an early second-line intervention.

This represents the second Phase 3 trial validating TECVAYLI-based treatment regimens as a potential new standard of care for patients experiencing initial relapse—a critical finding in the multiple myeloma landscape where treatment options become increasingly limited.

Regulatory Milestones and Market Expansion

JNJ’s TECVAYLI gained U.S. FDA accelerated approval in October 2022 as a ready-to-use subcutaneous antibody therapy. The drug was initially authorized for relapsed or refractory multiple myeloma (RRMM) patients who had received at least four prior lines of therapy, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibodies.

The treatment paradigm expanded in February 2024 when the FDA approved a supplemental Biologics License Application, enabling reduced dosing frequency of 1.5 mg/kg administered every two weeks for patients achieving and maintaining complete response (CR) or better for at least six months. This regulatory update enhances treatment convenience and patient tolerability.

European regulators granted conditional marketing authorization in August 2022, with approval applicable to adult RRMM patients who had received at least three prior therapies. Subsequently, the European Commission approved a Type II variation in August 2023, similarly permitting the reduced dosing schedule of 1.5 mg/kg every two weeks (Q2W) for responders maintaining CR or better for minimum six months.

Addressing Unmet Medical Needs

The clinical validation across multiple Phase 3 trials underscores TECVAYLI’s potential to transform outcomes for multiple myeloma patients with severely limited therapeutic alternatives. By demonstrating superior survival metrics compared to standard of care regimens, the therapy addresses a significant gap in oncology treatment options, particularly for patients progressing through conventional drug sequences.

Market Response

Johnson & Johnson shares closed regular trading Wednesday at $218.55, reflecting a $4.90 or 2.29% gain. In subsequent overnight trading at 10:14 PM EST, the stock traded at $218.06, down $0.49 or 0.22%, indicating continued investor interest in the company’s expanding clinical pipeline and regulatory achievements.