Results from the Phase 2 RedirecTT-1 study demonstrate deep responses with 78.9 percent overall response rate through dual targeting of GPRC5D and BCMA
Data signal potential of novel, off-the-shelf approach in patients with extramedullary disease who face significant unmet needs
MILAN, Italy I June 15, 2025 I Johnson & Johnson (NYSE: JNJ) announced today new results from the Phase 2 RedirecTT-1 study evaluating the investigational combination of TALVEY® (talquetamab-tgvs), the first U.S. Food and Drug Administration (FDA)-approved GPRC5D-directed bispecific antibody, and TECVAYLI® (teclistamab-cqyv), the first FDA-approved BCMA-directed bispecific antibody. The results show a high overall response rate (ORR) with durability in patients with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) who have true extramedullary disease (EMD). EMD is defined as soft tissue/organ-associated plasmacytomas with no contact to bony structures as per International Myeloma Working Group (IMWG) criteria.1 RedirecTT-1 is the largest study dedicated to patients with EMD to date. These data were featured in a late-breaking oral presentation (Abstract #LB4001) at the 2025 European Hematology Association (EHA) Congress.
EMD represents an aggressive form of multiple myeloma and occurs when myeloma cells spread and form tumors (plasmacytomas) elsewhere in the body, such as in soft tissues and organs. These patients often face limited treatment options and worse outcomes due to the complexity of the disease, including tumor heterogeneity, resulting in low ORRs and rapid relapses with current standard therapies. On average, TCE RRMM patients with EMD have an ORR of less than 40 percent and a median progression-free survival (PFS) of less than 6 months.2
“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, M.D., Head of Myeloma Unit, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.* “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.”
The Phase 2 RedirecTT-1 study enrolled 90 patients with TCE RRMM with true EMD. Of these patients, 84.4 percent were triple-class refractory, 35.6 percent were penta-drug refractory, 20 percent had previously received BCMA CAR-T therapy, and 8.9 percent had previously received a bispecific antibody.3 The investigational combination of TALVEY® plus TECVAYLI® led to a high ORR of 78.9 percent (95 percent confidence interval [CI]; 69.0–86.8), with more than half of patients (54.4 percent) achieving complete response or better.3 High responses were observed even in patients exposed to prior BCMA CAR-T or anti-FcRH5 bispecific antibodies (83.3 percent ORR; 58.6-96.4 and 75 percent ORR; 34.9-96.8, respectively).3 Among responders, 66.2 percent remained in response at the data cutoff, with a median follow-up of 13.4 months, signaling deep and durable responses.3 Treatment with the combination resulted in 61 percent of patients progression free and alive at one year.3 Additionally, the combination led to durable responses, with 64.1 percent of patients maintaining response (median duration of response: 13.8 months) and 74.5 percent of patients alive at one year, while median overall survival was not yet reached.3
“Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. “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.”
The safety profile of the combination was consistent with previous reports of TALVEY® and TECVAYLI® as monotherapies, with no new safety signals identified.3 Patients were given the option to switch to once a month dosing, potentially contributing to improved tolerability. Rates of discontinuation were low with the treatment combination of TALVEY® and TECVAYLI® due to adverse events (AEs).3 Four participants discontinued TALVEY® only.3 Reports of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) were mostly low grade.3 Of the ten patients who had Grade 5 AEs (11.1 percent), five were due to infections and five were unrelated.3 The rates of severe infection were similar to those observed with BCMA bispecific antibody monotherapies.3
About TALVEY®
TALVEY® (talquetamab-tgvs) received approval from the U.S. FDA in August 2023 as a first-in-class GPRC5D-targeting bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.4 Since FDA approval, more than 4,900 patients have been treated worldwide with TALVEY®. The European Commission (EC) granted conditional marketing authorization (CMA) of TALVEY® ▼ (talquetamab) in August 2023 as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.5
TALVEY® is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D), a novel multiple myeloma target which is highly expressed on the surface of multiple myeloma cells and nonmalignant plasma cells, as well as some healthy tissues such as epithelial cells of the skin and tongue.
About TECVAYLI®
TECVAYLI® (teclistamab-cqyv) received approval from the U.S. FDA in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.[6] Since FDA approval, more than 15,900 patients have been treated worldwide with TECVAYLI®. The European Commission (EC) granted TECVAYLI® conditional marketing authorization (CMA) in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023, the EC granted the approval of a Type II variation application for TECVAYLI®, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients who have achieved a complete response (CR) or better for a minimum of six months. TECVAYLI® is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In February 2024, the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI® for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients with relapsed or refractory multiple myeloma who have achieved and maintained a CR or better for a minimum of six months.
For more information, visit www.TECVAYLI.com.
About multiple myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.7 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.8 Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease.9 In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S., and more than 12,000 people would die from the disease.10 People living with multiple myeloma have a 5-year survival rate of 59.8 percent.[11] While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.12,13
INDICATION AND USAGE
TALVEY® (talquetamab-tgvs) is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Please read full Prescribing Information, including Boxed WARNING, for TALVEY®.
INDICATION AND USAGE
TECVAYLI® (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Please read full Prescribing Information, including Boxed WARNING, for TECVAYLI®.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and Janssen Scientific Affairs, LLC are Johnson & Johnson companies.
1 Ho, M.; Paruzzo, L.; Minehart, J.; Nabar, N.; Noll, J.H.; Luo, T.; Garfall, A.; Zanwar, S. Extramedullary Multiple Myeloma: Challenges and Opportunities. Curr. Oncol. 2025, 32, 182. https://doi.org/10.3390/curroncol32030182
2 Philippe Moreau et al, Outcomes of Patients With Extramedullary Disease in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma From the Pooled LocoMMotion and MoMMent Studies, Clinical Lymphoma, Myeloma and Leukemia, https://doi.org/10.1016/j.clml.2025.03.
3 Kumar, S., et al. Phase 2 Study of Talquetamab + Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma and Extramedullary Disease: RedirecTT-1. 2025 European Hematology Association Congress. June 2025.
4 TALVEY® U.S. Prescribing Information, August 2023.
5 European Medicines Agency. TALVEY Summary of Product Characteristics. August 2023.
6 U.S. FDA Approves TECVAYLI® (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma. Accessed May 2025.
7 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-5672020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178
8 National Cancer Institute. Plasma Cell Neoplasms. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq. Accessed November 2024.
9 City of Hope. Multiple Myeloma: Causes, Symptoms & Treatments. https://www.cancercenter.com/cancer-types/multiple-myeloma. Accessed November 2024.
10 American Cancer Society. Key Statistics About Multiple Myeloma. https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men%20and%2015%2C370%20in%20women. Accessed November 2024.
11 SEER Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute. https://seer.cancer.gov/explorer/. Accessed November 2024.
12 American Cancer Society. What is Multiple Myeloma? https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed November 2024.
13 American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html. Accessed November 2024.
SOURCE: Johnson & Johnson
