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Oracle Runs

Oracle findings and outcome history for A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (NCT04634552).

Runs
1
Findings
1
Latest Run
Apr 1, 2026, 8:22 PM
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
All Oracle Findings

Every stored oracle finding for this trial, including pending, dismissed, rejected, superseded, and accepted items.

YESAccepted95% confidenceGPT-5.4 (OpenAI)

Will the results be positive?

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.

Found Apr 1, 2026, 8:22 PMOutcome date Jun 3, 2023, 12:00 AMReviewed Apr 1, 2026, 8:24 PM
Sponsorjnj.comJun 3, 2023, 12:00 AM
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.
Sponsorinvestor.jnj.comAug 21, 2023, 12:00 AM
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.
Outcome History

Public history of accepted oracle reviews and recorded outcome changes for this trial.

Accepted Oracle Review (Legacy)Apr 1, 2026, 8:24 PM

Will the results be positive?

PendingtoYEScurrentYES
GPT-5.4 (OpenAI)95% confidenceReviewed Apr 1, 2026, 8:24 PM

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.