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RedirecTT-1

Myeloma Cancer

RedirecTT-1

Manufactured by: Janssen Pharmaceuticals
Product name: Talvey® (talquetamab) / Tecvayli® (teclistamab)

About the RedirecTT-1 Trial

The RedirecTT-1 trial is an open-label, phase 1b-2 study evaluating the combination of two bispecific antibodies—talquetamab and teclistamab—in patients with relapsed or refractory multiple myeloma (RRMM) who had been previously exposed to three major drug classes. Using a recommended phase 2 regimen of talquetamab 0.8 mg/kg and teclistamab 3.0 mg/kg every two weeks, the trial demonstrated an overall response rate (ORR) of 80%, with 86% of those responses maintained at 18 months. High response rates were observed even among patients with aggressive extramedullary disease. However, the combination therapy was associated with a high incidence of grade 3/4 adverse events, particularly infections, including infection-related mortality. The study was prominently featured at the IMS24 conference, where Dr. Yael Cohen presented the findings. Commentary from leading hematologists—including Dr. Rahul Banerjee, Dr. Tom Curley, and Dr. Aaron Goodman—highlighted the therapy’s potential advantages over CAR-T treatments in specific settings, while also emphasizing the need for careful management of toxicity risks.

Table of Contents

Major Presentations and Milestones

RedirecTT-1 Trial design, results, and conclusions

RedirecTT-1 Sentiments and Criticisms

RedirecTT-1 Temporal Sentiment Arc

Professional Resources : Interactive Tweet History, Influence Diagram, Sentiment Table, AI Chatbot

RedirecTT-1 Trial: Major Presentations and Milestones

Primary speakers driving the story

At ASH 2025, RedirecTT-1 (talquetamab + teclistamab) was presented with simultaneous New England Journal of Medicine (NEJM) publication, followed by a Late-Breaking session at EHA 2025 led by Shaji Kumar, MD (Mayo Clinic). KOLs emphasized that this is a dedicated study in true extramedullary disease (EMD), an area of high unmet need, and discussed both efficacy and infection signals under bispecific-bispecific combination therapy.

RedirecTT-1 Trial Design, Results, and Conclusions

Trial Design:

RedirecTT-1 is a phase 1b–2 study of talquetamab (GPRC5D-directed bsAb) plus teclistamab (BCMA-directed bsAb) in relapsed/refractory multiple myeloma, including a dedicated cohort with true extramedullary disease (EMD). Dosing shared by a KOL for the RP2D cohort: teclistamab 3 mg/kg every 2 weeks plus talquetamab 0.8 mg/kg every 2 weeks; populations included heavily pretreated patients (e.g., triple-class and penta-refractory proportions reported in session commentary).

Primary Results:

NEJM and meeting summaries consistently reported high response rates with the combination in drug-resistant EMD, with 12‑month PFS and OS signals but notable infection risk. KOLs highlighted:

Visceral EMD durability at RP2R was underscored by an 18‑month duration of response (DOR) estimate, with experts discussing implications versus cellular therapies:

Additional cohort summaries shared by KOLs:

Safety:

KOLs emphasized infection risk with the dual-bispecific regimen. Reported rates varied by cohort/cut (e.g., grade 3/4 infections ~31% to 64%), with several posts noting IVIG use and infection prophylaxis as critical mitigations and multiple AE‑related deaths in datasets presented at ASH25.

Key Conclusions:

Talquetamab + teclistamab produces high response rates and meaningful 12‑month PFS/OS in drug‑resistant true EMD, with especially notable DOR in visceral EMD at RP2R. Infection is the dominant safety concern and a driver of supportive‑care strategy; clinicians highlighted the need for rigorous prophylaxis/IVIG and careful patient selection. Comparative positioning versus BCMA CAR‑T and optimal sequencing remain active discussion points.

RedirecTT-1 Sentiments and Criticisms

Positive Reception:

Vincent Rajkumar, MD: "Just out in @NEJM Effective therapy of extra medullary relapsed myeloma with teclistamab plus talquetamab (Tec-Tal). RedirecTT-1 #ASH25 @myelomaMD @szusmani @mvmateos 80% response rate. 60% PFS at 12 months." https://x.com/VincentRK/status/1997810461019144676

Multiple Myeloma Hub (Shaji Kumar presentation): "Tal + Tec led to an ORR of 78.9% and a ≥CR rate of 54.4%; efficacy exceeded standard therapies" https://x.com/MM_Hub/status/1934152824541118753

Rahul Banerjee, MD, FACP: "Tec + tal as a bsAb cocktail in #MMsm. Impressive responses … tal/tec combo probably beats BCMA CAR-T!" https://x.com/RahulBanerjeeMD/status/1877178863370789271

Critical Perspectives:

Urvi Shah, MD: "@bdermanmd @hhashmi87 Agreed and the high infection risk and mortality is concerning. For most patients sequencing the drugs is likely a safer option." https://x.com/UrviShahMD/status/1879314800414732497

RedirecTT-1 Temporal Sentiment Arc

2024 (IMS24: Early Signal and Safety Focus)

Primary/KOL tweets:

  • https://x.com/Rfonsi1/status/1839645403978830185
  • Tone: Emerging enthusiasm for combination activity even in visceral EMD, with early recognition of infection management (IVIG/prophylaxis) as essential.
  • Shift: From proof‑of‑concept signal to operational infection mitigation.

January 2025 (NEJM Publication)

Primary/KOL tweets:

June 2025 (EHA25 Late-Breaking)

Primary/KOL tweets:

December 2025 (ASH25 Simultaneous Presentation and NEJM Coverage)

Primary/KOL tweets:

Across cycles, the discourse moved from early efficacy signals to mature, benchmark-level data in true EMD. The clinical community converged on the regimen’s strong activity and durability—particularly at RP2R in visceral EMD—while emphasizing comprehensive infection prevention, monitoring, and individualized sequencing.

RedirecTT-1 Professional Resources

RedirecTT-1 at a Glance

Design - Phase 1b/2 open-label study (Janssen) of the first bispecific-plus-bispecific combination in myeloma: talquetamab (GPRC5D x CD3) plus teclistamab (BCMA x CD3) in relapsed/refractory multiple myeloma exposed to the three major drug classes, including a dedicated cohort with true extramedullary disease (EMD). RP2R: talquetamab 0.8 mg/kg + teclistamab 3.0 mg/kg every two weeks.

Response (RP2R cohort) - ORR 80% at the recommended Phase 2 regimen, with 86% of responses maintained at 18 months; high response rates were seen even in patients with aggressive extramedullary disease (IMS 2024, presented by Dr. Yael Cohen).

EMD cohort - In the dedicated extramedullary disease cohort - a population of high unmet need - ORR was 78.9% with >=CR of 54.4% (EHA 2025 late-breaking presentation by Dr. Shaji Kumar, with simultaneous NEJM publication).

Safety - High incidence of grade 3/4 adverse events, particularly infections, including infection-related mortality - the key trade-off KOLs emphasized for dual-bispecific therapy.

Regulatory / sponsor - Combination is investigational (Janssen-sponsored). Talquetamab (Talvey) and teclistamab (Tecvayli) are each FDA-approved individually as monotherapy for RRMM after >=4 prior lines (accelerated approvals, Aug 2023 and Oct 2022 respectively); the doublet is not approved.

Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated August 19, 2026.

RedirecTT-1 Frequently Asked Questions

What is the RedirecTT-1 trial?

RedirecTT-1 (NCT04586426) is a Phase 1b/2 open-label study sponsored by Janssen evaluating the combination of two bispecific T-cell-redirecting antibodies - talquetamab (targeting GPRC5D) and teclistamab (targeting BCMA) - in patients with relapsed or refractory multiple myeloma previously exposed to the three major drug classes. It includes a dedicated cohort for patients with extramedullary disease, an area of high unmet need.

What did RedirecTT-1 show?

At the recommended Phase 2 regimen (talquetamab 0.8 mg/kg plus teclistamab 3.0 mg/kg every two weeks), the combination achieved an overall response rate of 80%, with 86% of responses maintained at 18 months (IMS 2024). In the dedicated extramedullary disease cohort, ORR was 78.9% with a >=CR rate of 54.4%, presented as an EHA 2025 late-breaker by Dr. Shaji Kumar with simultaneous NEJM publication.

Is the talquetamab plus teclistamab combination FDA approved?

No - the combination is investigational. Each drug is separately FDA-approved as monotherapy for relapsed/refractory multiple myeloma after at least four prior lines of therapy: teclistamab (Tecvayli) received accelerated approval in October 2022 and talquetamab (Talvey) in August 2023. Using them together, as tested in RedirecTT-1, is not an approved regimen.

What is the safety profile of the RedirecTT-1 combination?

The dual-bispecific combination was associated with a high incidence of grade 3/4 adverse events, particularly infections, including infection-related deaths. Hematologists commenting on the data stressed that infection prophylaxis and careful toxicity management are essential if bispecific-bispecific therapy moves forward.

Why is the RedirecTT-1 trial important?

RedirecTT-1 is the first trial to combine two bispecific antibodies against different myeloma targets (GPRC5D and BCMA), and it delivered high, durable response rates in extramedullary disease - a setting where CAR-T and single bispecifics underperform. KOLs including Dr. Rahul Banerjee and Dr. Aaron Goodman highlighted its potential advantages over CAR-T in specific settings, balanced against the infection risk.