TALVEY® Shows Long-Lasting Responses in Relapsed/Refractory Multiple Myeloma

Johnson & Johnson recently revealed promising long-term data from the Phase 1/2 MonumenTAL-1 study, showcasing the effectiveness of TALVEY® (talquetamab-tgvs) in treating relapsed or refractory multiple myeloma (RRMM). This study included patients who had previously been exposed to multiple classes of drugs. The findings were presented at the 2024 European Hematology Association (EHA) Congress, highlighting TALVEY®'s sustained response and survival rates irrespective of prior T-cell redirection therapy exposure.

The Phase 1/2 MonumenTAL-1 study involved 297 patients with no prior T-cell therapy exposure. These patients received TALVEY® at either 0.8 mg/kg biweekly (Q2W) or 0.4 mg/kg weekly (QW). At a median follow-up of 23.4 months, the Q2W cohort exhibited a median duration of response (DOR) of 17.5 months, with those achieving complete response (CR) showing even more durable results. In the QW cohort, a median follow-up of 29.8 months revealed a median DOR of 9.5 months, extending to 28.6 months in patients with CR or better. At 24 months, 67.1 percent of the Q2W cohort and 60.6 percent of the QW cohort were still alive.

Among patients previously treated with T-cell redirection therapies, TALVEY® maintained strong efficacy. With a median follow-up of 20.5 months, 55.1 percent of these patients achieved very good partial response (VGPR) or better, and 57.3 percent were alive at 24.2 months. Additionally, the study reported lower infection rates compared to B-cell maturation antigen-targeted bispecific antibodies, with no significant increase in grade 3/4 infections.

The Phase 1b MonumenTAL-2 study explored the use of TALVEY® in combination with pomalidomide in 35 patients with RRMM. At a median follow-up of 16.8 months, this combination therapy demonstrated an overall response rate (ORR) of 88.6 percent, with 80 percent achieving VGPR or better. The progression-free survival (PFS) rate at 12 months was 72.6 percent. The most common hematologic adverse events included neutropenia, anemia, and thrombocytopenia, while non-hematologic adverse events such as taste and skin toxicities were primarily grade 1/2.

Dr. Leo Rasche, from the University Hospital of Würzburg, emphasized the promising results from both studies, noting the deep responses achieved with TALVEY® and the manageable safety profile. Dr. Jordan Schecter of Johnson & Johnson highlighted TALVEY®'s versatility as a treatment option for RRMM, both as monotherapy and in combination with immunomodulatory agents.

TALVEY® was approved by the U.S. FDA in August 2023 for the treatment of adult patients with RRMM. Since its approval, over 1,500 patients have been treated with TALVEY®. The European Commission also granted conditional marketing authorization for TALVEY® in August 2023 for adults with RRMM who had undergone at least three prior therapies.

The MonumenTAL-1 study aimed to assess the safety and efficacy of TALVEY® in over 300 patients with RRMM. Excluded were patients with prior T-cell therapy within three months, grade 3 or higher CRS from any T-cell therapy, recent stem cell transplants, or specific health conditions. The study's Phase 2 component focused on evaluating TALVEY®'s efficacy based on ORR and DOR.

The MonumenTAL-2 study is an ongoing Phase 1 trial assessing TALVEY® in combination with various drugs for RRMM treatment. The primary goal is to identify and characterize the safety of these combinations, with secondary objectives including overall response rates and time to response.

Multiple myeloma is a challenging and incurable blood cancer affecting plasma cells in the bone marrow. It is the third most common blood cancer, with over 35,000 new cases and more than 12,000 deaths estimated in the U.S. in 2023. Despite being often asymptomatic initially, multiple myeloma can cause symptoms such as bone pain, anemia, fatigue, high calcium levels, and kidney issues.

Overall, the data from the MonumenTAL-1 and MonumenTAL-2 studies underscore TALVEY®'s potential as an effective treatment for relapsed or refractory multiple myeloma, with durable responses and an acceptable safety profile, providing new hope for patients battling this complex disease.