Saturday, July 13, 2024

Multiple Myeloma Advances with Durable TALVEY® Responses, Reports Johnson & Johnson

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Johnson & Johnson recently announced long-term data from the Phase 1/2 MonumenTAL-1 study, demonstrating durable responses in patients with relapsed or refractory multiple myeloma (RRMM) treated with TALVEY® (talquetamab-tgvs). With a follow-up of 20 to 30 months, patients treated with TALVEY® maintained high overall response rates (ORR) and durable responses, irrespective of prior T-cell redirection therapy. These findings were presented at the 2024 European Hematology Association (EHA) Congress, underscoring the efficacy and durability of TALVEY® in treating triple-class-exposed patients with RRMM.

The MonumenTAL-1 study involved 297 patients who had not received prior T-cell redirection therapy. They were treated with TALVEY® at the recommended Phase 2 dose (RP2D) of 0.8 mg/kg biweekly (Q2W) or 0.4 mg/kg weekly (QW). At a median follow-up of 23.4 months for the Q2W cohort, the median duration of response (DOR) was 17.5 months. In the QW cohort, with a median follow-up of 29.8 months, the median DOR was 9.5 months. Patients with a complete response (CR) or better showed even longer median DOR. The 24-month overall survival rates were 67.1% and 60.6% for the Q2W and QW cohorts, respectively.

Patients with prior T-cell redirection therapy exposure also showed strong efficacy, with 55.1% achieving a very good partial response (VGPR) or better and 57.3% alive at 24.2 months. Infection rates remained low compared to other B-cell maturation antigen–targeted bispecific antibodies, with no increase in grade 3/4 infections. Adverse events (AEs) led to few dose reductions and discontinuations, and one additional patient discontinued treatment due to AEs since the last report. Weight loss stabilized over time, even in patients with oral toxicities.

MonumenTAL-2 Study Highlights TALVEY® and Pomalidomide Combo Efficacy for Multiple Myeloma

The MonumenTAL-2 study provided further insights into the potential of combining TALVEY® with pomalidomide for patients with RRMM. The Phase 1b study showed deep responses and a manageable safety profile, supporting the combination of TALVEY® with an immunomodulatory agent (IMiD). At a median follow-up of 16.8 months, response-evaluable patients demonstrated an ORR of 88.6%, with 80% achieving VGPR or better.

Patients treated with subcutaneous TALVEY® at 0.8 mg/kg biweekly or 0.4 mg/kg weekly, along with 2.0 mg of oral pomalidomide daily, showed promising results. The progression-free survival (PFS) rate at 12 months was 72.6%. The most common grade 3/4 hematologic AEs included neutropenia (57.1%), anemia (25.7%), and thrombocytopenia (20%). Taste, nail, skin, and rash toxicities were common but mostly grade 1/2. Cytokine release syndrome (CRS) occurred in 74.3% of patients, and infections occurred in 80%, with 22.9% being grade 3/4.

Jordan Schecter, Vice President, Disease Area Leader, and Multiple Myeloma at Johnson & Johnson Innovative Medicine, highlighted the versatility of TALVEY®, which can be used before or after CAR-T therapy and BCMA bispecifics. The low rate of grade 3/4 infections suggests TALVEY®’s flexibility as a combination partner with an immunomodulatory agent, offering important treatment options for patients with complex hematologic diseases.

Multiple Myeloma

TALVEY® Gains FDA Approval and EU Authorization for Treating Multiple Myeloma

TALVEY® received the U.S. Food and Drug Administration (FDA) approval in August 2023 for treating adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. The European Commission also granted conditional marketing authorization for TALVEY® as monotherapy for patients with RRMM who have received at least three prior therapies. TALVEY® is a bispecific T-cell engaging antibody that targets the CD3 receptor on T-cells and GPRC5D on multiple myeloma cells, as well as some healthy tissues.

MonumenTAL-1 is a Phase 1/2 single-arm, open-label, multicohort study evaluating TALVEY® in adults with RRMM who received three or more prior lines of therapy. Phase 2 assessed the efficacy of TALVEY® at the recommended Phase 2 doses. The MonumenTAL-2 study is an ongoing Phase 1 study evaluating TALVEY® in combination with other agents for treating multiple myeloma. The study aims to characterize the safety and efficacy of these combinations.

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TALVEY® offers a promising treatment option for patients with multiple myeloma, aiming to improve survival and quality of life. The robust data from MonumenTAL-1 and MonumenTAL-2 studies highlight its potential to significantly impact the treatment landscape for this challenging disease.

 

Resource: Johnson & Johnson, June 14, 2024

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