Johnson & Johnson’s Talvey-Tecvayli Combination Demonstrates High Overall Response Rate in Relapsed/Refractory Multiple Myeloma, True Extramedullary Disease

Author(s):

Results from the Phase II RedirecTT-1 trial showed a 78.9% overall response with the combination of Talvey plus Tecavli for heavily pretreated patients with relapsed/refractory multiple myeloma and true extramedullary disease.

Image Credit: Adobe Stock Images/Dr_Microbe

Key Takeaways

Talvey and Tecvayli Combination Delivers 78.9% overall response rate: In heavily pretreated relapsed/refractory multiple myeloma patients with true extramedullary disease, as over half achieved a complete response or better.
RedirecTT-1 is the Largest Study to Date Focused on Extramedullary Multiple Myeloma: Addressing a high-risk population with limited treatment options and poor outcomes under standard therapies.
Dual bispecific targeting of GPRC5D and BCMA shows durable efficacy: Supporting its potential as a new treatment strategy with manageable safety in advanced multiple myeloma.

Results from the Phase II RedirecTT-1 study show that Johnson & Johnson’s (J&J) investigational combination of Talvey (talquetamab-tgvs) and Tecvayli (teclistamab-cqyv) demonstrated a high overall response rate (ORR) in patients with relapsed/refractory multiple myeloma (RRMM) and true extramedullary disease (EMD), with more than half also achieving a complete response (CR) or better. Full results were presented at the 2025 European Hematology Association (EHA) Congress.¹

Can Dual-Targeting with Talvey and Tecvayli Deliver Deeper Responses for Patients with Aggressive Multiple Myeloma?

“The investigational combination of Talvey and Tecvayli has demonstrated deep, durable responses in patients with relapsed or refractory multiple myeloma and now shows great promise in those with extramedullary myeloma, where standard therapies often fall short,” said Yael Cohen, MD, head, myeloma unit, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, in a press release. “Dual targeting of GPRC5D and BCMA may lead to a higher ORR and greater depth of response by mitigating target antigen-related escape. The RedirecTT-1 trial shows the power of this novel dual-targeting combination approach as a potential treatment option for patients with this disease.”

Regulatory Background

Talvey received FDA approval in August 2023 as a first-in-class GPRC5D-targeting bispecific antibody for adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Tecvayli was approved in October 2022 for a similar RRMM population, targeting BCMA.¹

Study Design and Patient Characteristics

The open-label RedirecTT-1 trial evaluated the safety and efficacy of Talvey plus Tecvayli in 90 patients with triple-class exposed RRMM and true EMD.
Among these patients, 84.4% were triple-class refractory, 35.6% were penta-drug refractory, 20% had previously received BCMA chimeric antigen receptor T-cell therapy, and 8.9% had received a bispecific antibody.
Endpoints included ORR, CR, duration of response (DOR), progression-free survival (PFS), and overall survival (OS).^1,2

Efficacy Outcomes

The combination therapy achieved an ORR of 78.9%, with 54.4% of patients achieving a CR or better.
The median DOR was 13.8 months. Sixty-one percent of patients demonstrated PFS after one year of treatment.
At one year, 74.5% of patients were alive, although the median OS had not yet been reached.

Safety Profile

The safety profile of the combination was consistent with the monotherapy profiles of Talvey and Tecvayli, with no new safety signals reported.
The most common adverse events (AEs) included pyrexia; cytokine release syndrome; dysgeusia; nail disorder; musculoskeletal pain; skin disorder; rash; fatigue; weight decreased; dry mouth; xerosis; dysphagia; upper respiratory tract infection; diarrhea; hypotension; and headache.
Two patients discontinued only Talvey due to AEs.
Around 11.1% of patients had grade 5 AEs—five due to infections and five unrelated to treatment.¹

Multiple Myeloma Incidence and Mortality Trends

According to the American Cancer Society, the lifetime risk of developing multiple myeloma (MM) in the United States is less than 1%. The disease is most common in older adults, with a median age at diagnosis of 69 years, and less than 1% of cases occur in individuals under 35 years of age. By the end of 2025, an estimated 36,110 new MM cases and 12,030 related deaths are expected in the United States.³

“Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options,” said Jordan Schecter, MD, VP, disease area leader, multiple myeloma, Johnson & Johnson Innovative Medicine, in the press release. “Our first-in-class bispecific antibodies Talvey and Tecvayli have transformed treatment for relapsed or refractory multiple myeloma. The RedirecTT-1 study underscores our commitment to advancing innovative therapies that attack the disease in different ways by building combinable and complementary regimens.”

References

1. Investigational combination of first-in-class bispecifics TALVEY® and TECVAYLI® shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease. J&J. June 15, 2025. Accessed June 17, 2025. https://www.jnj.com/media-center/press-releases/investigational-combination-of-first-in-class-bispecifics-talvey-and-tecvayli-shows-deep-and-durable-responses-in-heavily-pretreated-multiple-myeloma-patients-with-extramedullary-disease

2. RedirecTT-1 (MMY1003) Study - TALVEY AND TECVAYLI Cohort. J&J. Accessed June 17, 2025. https://www.jnjmedicalconnect.com/products/talvey/medical-content/redirectt1-mmy1003-study-talvey-and-tecvayli-cohort

3. Key Statistics About Multiple Myeloma. American Cancer Society. Accessed June 17, 2025. https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html

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