Patrick Daly

Urban Health Today

Teclistamab is approved for the treatment of relapsed or refractory <a href="https://urbanhealthtoday.com/page/multiple-myeloma">multiple myeloma</a> (RRMM) in patients who previously received immunomodulatory, proteasome inhibitor, and anti-CD38 antibody therapies.In a study published in Targeted Oncology, researchers characterized the pharmacokinetics and exposure-response of intravenous and subcutaneous (SC) teclistamab based on data from the phase 1/2 MajesTEC-1 study.According to the study&rsquo;s authors, body weight, myeloma type, and International Staging System stage statistically significantly affected the pharmacokinetics of teclistamab in patients with RRMM, though not with a clinically relevant change in efficacy. The study also defined the exposure-response of teclistamab and identified a recommended phase 2 dose (RP2D) for SC teclistamab of 0.06 and 0.30 mg/kg step-up doses, followed by a weekly dose of 1.5 mg/kg.<h2>Teclistamab Outcomes at Recommended Phase 2 Dose</h2>The study included 4840 serum concentration samples from 338 evaluable patients with RRMM who received <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf">teclistamab</a> in MajesTEC-1. In the dose-expansion phase, the objective response rate reached a plateau at the concentration range associated with the RP2D, while patients who started at the RP2D showed a flat exposure-response curve.The typical population value of time-independent and time-dependent teclistamab clearance were 0.449 L/day and 0.547 L/day, respectively. After 8 weeks of treatment, time-dependent clearance decreased to &lt;10%. There were no apparent associations between duration of response, progression-free survival, overall survival, or the rate of grade 3 or higher adverse events.&ldquo;These analyses support the RP2D of teclistamab (1.5 mg/kg SC administered weekly, with the first treatment dose preceded by step-up doses of 0.06 mg/kg and 0.30 mg/kg) for the treatment of patients with RRMM,&rdquo; authors concluded.&nbsp;Related: <a href="https://urbanhealthtoday.com/post/black-patients-with-multiple-myeloma-under-enrolled-in-imwg-data">Black Patients With Multiple Myeloma Under-Enrolled in IMWG Data</a>

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Phase 2 Results of Teclistamab in Relapsed or Refractory Multiple Myeloma

Multiple Myeloma

Findings from the phase 1/2 MajesTEC-1 study established a recommended dosing schedule for subcutaneous teclistamab in patients with relapsed or refractory multiple myeloma.

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