Dual Targeting of Extramedullary Myeloma with Talquetamab and Teclistamab.
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Kumar Shaji, Mateos María-Victoria, Ye Jing Christine, Atrash Shebli, Magen Hila, Quach Hang, Chu Michael P, Trudel Suzanne, Richter Joshua, Rodríguez-Otero Paula, Chuah Hun, Gatt Moshe, Medvedova Eva, Raza Shahzad, Yoon Dok Hyun, Ishida Tadao, Matous Jeffrey V, Rosiñol Laura, Onodera Koichi, Scott Emma, Heuck Christoph, Zhang Jenny, Henninger Todd, O'Rourke Lisa, Thakkar Payal, Festa Mariacristina, Huang Lin, Zhou Jiangxiu, Takamoto Mikihiro, Pei Lixia, Lu Jiashen, Au Nicholas, Krevvata Maria, Usmani Saad Z, Cohen Yael C, RedirecTT-1 Investigators Study Group
Аннотация
METHODS: In this phase 2 study, we investigated talquetamab plus teclistamab exclusively in patients with drug-resistant, true extramedullary myeloma. The primary end point was overall response, evaluated with the use of functional imaging. Secondary end points included the duration of response, progression-free survival, overall survival, and safety.
RESULTS: A total of 90 patients were enrolled in the study and received treatment (median follow-up, 12.6 months). A response occurred in 79% of the patients (95% confidence interval [CI], 69 to 87). Among the patients with a response, the percentage with a response duration of at least 12 months was 64% (95% CI, 48 to 76). At 12 months, progression-free survival was 61% (95% CI, 50 to 71), and overall survival was 74% (95% CI, 63 to 83). Common adverse events of any grade included oral symptoms, such as dysgeusia, dry mouth, and dysphagia (in 87% of the patients); cytokine release syndrome (in 78%); and nonrash skin effects (in 69%). Grade 3 or 4 adverse events (most commonly hematologic events) occurred in 76% of the patients; 31% had grade 3 or 4 infection. A nonfatal adverse event led to discontinuation of one or both agents in 6% of the patients. Among 10 deaths that occurred during follow-up, 5 were due to infection and 5 were considered to be related to the study treatment.
CONCLUSIONS: Most patients with drug-resistant, true extramedullary myeloma had a response with talquetamab plus teclistamab. The incidence of adverse events of grade 3 or above was high and was consistent with previous observations for each agent as monotherapy. (Funded by Johnson & Johnson; RedirecTT-1 ClinicalTrials.gov number, NCT04586426.).