Tuesday, July 16, 2024

Multiple Myeloma Treatment with TECVAYLI® Shows Promising Long-Term Efficacy

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Johnson & Johnson announced long-term data from the MajesTEC-1 study showing TECVAYLI® (teclistamab-cqyv) offers deep and durable responses in relapsed or refractory multiple myeloma (RRMM) patients. The Phase 1/2 study revealed a median duration of response of 24 months, with responses deepening over time, even in patients switching to biweekly dosing. Additional analyses from MajesTEC-1 and OPTec studies highlight the potential for outpatient administration of TECVAYLI® with prophylactic tocilizumab. These findings were presented at the ASCO Annual Meeting and EHA Congress, showcasing a significant reduction in cytokine release syndrome (CRS) and paving the way for more convenient treatment approaches.

At a median follow-up of 30.4 months, TECVAYLI® treated patients had an overall response rate (ORR) of 63%, with 46% achieving complete response (CR) or better. The median duration of response (mDOR), progression-free survival (mPFS), and overall survival (mOS) were not yet reached. Patients switching to biweekly dosing maintained their responses, with a consistent safety profile, and reduced severe infections over time.

Subgroup analysis from the MajesTEC-1 study showed that high-risk (HR) patients, including those aged 75 or older and those with HR cytogenetics or penta-drug refractory disease, also benefited significantly from TECVAYLI® treatment. The ORR in these subgroups was comparable to the overall population, demonstrating TECVAYLI®’s effectiveness in challenging cases.

TECVAYLI® Shows High ORR in Newly Diagnosed Multiple Myeloma Patients in MajesTEC-7 Study

The MajesTEC-7 study presented early clinical data for a TECVAYLI®-based regimen in newly diagnosed multiple myeloma patients ineligible for transplant. Preliminary results showed a high ORR of 92%, with manageable safety profiles, further supporting TECVAYLI®’s potential as a frontline treatment.

MajesTEC-1 is a Phase 1/2 study evaluating TECVAYLI® in adults with RRMM who received three or more prior lines of therapy. The study consists of dose escalation and dose expansion phases to assess safety, tolerability, and efficacy. OPTec, a Phase 2 study, focuses on using prophylactic tocilizumab to reduce CRS incidence in an outpatient setting. MajesTEC-7 is a Phase 3 study comparing TECVAYLI® in combination with other treatments in newly diagnosed multiple myeloma patients ineligible for transplant.

TECVAYLI® (teclistamab-cqyv) received FDA approval in October 2022 for treating RRMM in patients with at least four prior lines of therapy. The European Commission granted conditional marketing authorization in August 2022. TECVAYLI® is a first-in-class bispecific T-cell engager antibody that binds to CD3 on T-cells and BCMA on myeloma cells, activating the immune system to target cancer cells.

Multiple Myeloma

Multiple Myeloma Treatment with TECVAYLI® Shows Potential Despite Risks and Side Effects

Multiple myeloma is a blood cancer affecting plasma cells in the bone marrow. It remains incurable, with over 35,000 new cases and 12,000 deaths estimated in the U.S. in 2024. Patients have a 5-year survival rate of 59.8%. Symptoms include bone pain, fractures, anemia, fatigue, high calcium levels, and kidney problems.

TECVAYLI® can cause cytokine release syndrome (CRS) and neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). It is available only through a restricted program called the TECVAYLI® and TALVEY™ REMS. Monitor patients for signs of CRS and neurologic toxicity and provide supportive care as needed. TECVAYLI® can also cause hepatotoxicity, infections, neutropenia, and hypersensitivity reactions. Advise patients to use effective contraception during treatment and for 5 months after the last dose due to potential embryo-fetal toxicity.

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Common adverse reactions (≥20%) include pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. Common Grade 3-4 laboratory abnormalities (≥20%) include decreased lymphocytes, neutrophils, white blood cells, hemoglobin, and platelets.

 

Resource: Johnson & Johnson, June 03, 2024

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