Janssen Adjusts Course: Multiple Myeloma Phase 3 Trial Delayed by 2 Years

Janssen's Multiple Myeloma Trial Delayed by Nearly Two Years

• Janssen Research & Development, LLC has experienced a significant delay in its Phase 3 trial, which contrasts the effects of Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone with a regimen of VELCADE, Lenalidomide, and Dexamethasone in untreated multiple myeloma patients.
• Originally slated to wrap up by September 08, 2023, the trial, which encompasses 395 participants across 114 sites, is now expected to conclude on August 29, 2025.
• While not every trial delay suggests problems, according to AppliedXL data, trials with notable delays have a higher likelihood of ending prematurely. Such delays might hint at challenges in enrollment, drug performance, or trial execution, and could potentially affect their time to market.

‍Janssen's Comprehensive Approach to Multiple Myeloma

• Within its extensive program extending until 2025, Janssen is overseeing six trials in MM ; four are currently active with two having been finalized. These studies, spread across Phase 2 to Phase 3, explore various drug combinations, with a prime focus on daratumumab, in addressing multiple myeloma.

‍Contenders in the MM therapeutic arena

• Celgene: Actively researching BB2121 combined with other therapies for multiple myeloma with a culmination expected by April 08, 2027.
• Takeda: Evaluating Ixazomib's role as a maintenance solution for newly diagnosed multiple myeloma patients with an estimated wrap-up by September 01, 2024.
• Sanofi: Probing into isatuximab in tandem with various agents for high-risk smoldering and relapsed or refractory multiple myeloma, with studies set to finalize by June 01, 2028.

Sources: Clinicaltrials.gov, PubMed, Press Releases, and AppliedXL. This report is generated algorithmically and may not cover all ongoing industry-sponsored trials. AppliedXL implements rigorous AI vetting processes but cannot guarantee the completeness of all insights.