Investigational combination of first-in-class bispecifics TALVEY ® and TECVAYLI ® shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease

Data from the Phase 2 RedirecTT-1 study showed that the investigational combination of TALVEY and TECVAYLI led to a 78.9% overall response rate in patients with relapsed or refractory multiple myeloma (RRMM) with extramedullary disease (EMD), a difficult-to-treat condition where myeloma cells spread to form tumors in soft tissues and organs. More than half of patients (54.4%) achieved complete response or better, and high responses were observed even in patients exposed to prior BCMA CAR-T or anti-FcRH5 bispecific antibodies (83.3% ORR and 75% ORR, respectively), signaling deep and durable responses with 61% of patients progression free and alive at one year. The safety profile was consistent with previous reports of TALVEY and TECVAYLI as monotherapies, with no new safety signals identified.

Analysis

Phase 2 RedirecTT-1 study results for Johnson & Johnson's investigational combination of TALVEY (talquetamab-tgvs) and TECVAYLI (teclistamab-cqyv) demonstrate substantial efficacy in patients with relapsed or refractory multiple myeloma (RRMM) and extramedullary disease (EMD), a particularly aggressive form of the cancer with historically poor outcomes. The study reported a 78.9% overall response rate (ORR) in 90 heavily pre-treated patients, 84.4% of whom were triple-class refractory. Notably, 54.4% achieved a complete response or better, and high ORRs were maintained even in patients previously exposed to BCMA CAR-T therapy (83.3%) or anti-FcRH5 bispecific antibodies (75%). The responses appear durable, with 66.2% of responders maintaining response at a median follow-up of 13.4 months, 61% of patients progression-free and alive at one year, and a median duration of response of 13.8 months. Overall survival data is also promising, with 74.5% of patients alive at one year and median overall survival not yet reached. The safety profile was consistent with the known profiles of TALVEY and TECVAYLI as monotherapies, with no new safety signals identified, and low rates of discontinuation due to adverse events. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were mostly low grade, though Grade 5 adverse events occurred in 11.1% of patients (five due to infections, five unrelated). Both TALVEY and TECVAYLI are approved under accelerated approval, contingent upon confirmatory trial data, and are subject to a Risk Evaluation and Mitigation Strategy (REMS) program.

Key Decisions for Investors

• These positive Phase 2 results for the TALVEY and TECVAYLI combination in a high unmet need EMD population represent a significant advancement for Johnson & Johnson's oncology franchise, potentially expanding the addressable market for these therapies.
• Investors should closely monitor the progress and outcomes of confirmatory trials for both TALVEY and TECVAYLI, as continued approval and broader commercial success are contingent upon these results.
• The high efficacy in heavily pre-treated patients, including those with prior exposure to advanced therapies, suggests a strong clinical profile, though market adoption will also depend on the manageable safety profile and physician comfort with the REMS program.
• Given the 'strongly positive' sentiment and the promising efficacy and durability data, these findings could positively influence JNJ's near-term outlook in the oncology space, pending further regulatory milestones and competitive landscape developments.