A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Market
0.0%
Details
- Resolved Date
- 6/3/23
- Study Completion
- 3/30/29
- Company
- Janssen Research & Development, LLC
- Ticker
- JNJ
- Type
- Trial Status
- Recruiting
- Trial Size
- 510
- Volume
- $0
- NCT
- NCT04634552
- Drug Description
- The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).
Resolution Evidence
- Outcome
- YES
- Status
- Resolved
- Settlement Date
- 4/1/26 UTC
- Executive Summary
Public trial-specific readout is already positive. Janssen’s June 3, 2023 update for MonumenTAL-1/NCT04634552 reported ORR >70% at the RP2Ds and described efficacy/safety as highlighted by the study. A later J&J approval release explicitly says the phase 1/2 MonumenTAL-1 data, including NCT04634552, were positive and showed meaningful ORRs.
Sources
Sponsorjnj.com6/3/23
Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma
J&J says updated results from pivotal MonumenTAL-1 highlighted safety and efficacy; for phase 2 NCT04634552 at the RP2Ds, ORR was 71.7% Q2W and 74.1% QW.
View source
Sponsorinvestor.jnj.com8/21/23
European Commission Approves TALVEY (talquetamab), Janssen’s Novel Bispecific Therapy for Relapsed and Refractory Multiple Myeloma
J&J states the authorization was supported by positive results from MonumenTAL-1 (NCT03399799/NCT04634552), with meaningful ORRs across both phase 2 doses.
View source
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