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Bispecific T-cell engagers & bispecifics

Oncologyยท 11 reviewed drugsยท 9964 cited findings behind them

What the regulatory reviews cover

This library includes several bispecific T-cell engagers and bispecifics that have undergone regulatory review. These drugs are indicated for various cancers, including multiple myeloma, non-small cell lung cancer, small cell lung cancer, and lymphoma. The review documents provide insights into their efficacy and safety profiles, though it is important to note that different drugs were studied in different trials, so figures are not head-to-head comparisons.

For instance, Talvey demonstrated an Overall Response Rate (ORR) of 73% for its 0.4 mg/kg weekly regimen in relapsed or refractory multiple myeloma. Imdelltra showed a Median OS (tarlatamab) of 13.6 months in extensive stage small cell lung cancer, compared to 8.3 months for SoC. In relapsed or refractory diffuse large B-cell lymphoma, Tepkinly achieved an ORR for Epcoritamab 48mg (Cohort 2b Dose expansion part) of 97.6%. For relapsed or refractory multiple myeloma, Elrexfio reported an Overall Response Rate (ORR) by BICR of 75 (61.0) %.

The drugs โ€” one cited result each

Rybrevant

Johnson & Johnson

1758 cited findings on the drug page โ†’
Talvey

Johnson & Johnson

Overall Response Rate (ORR) for 0.4 mg/kg weekly regimen: 73%

Johnson & Johnson โ€” Talvey FDA Review, p.27

Imdelltra

Amgen Inc.

Median OS (tarlatamab): 13.6

Amgen Inc. โ€” Imdelltra FDA Review (NDA/BLA 761344, 2026), p.337

Tepkinly

AbbVie Inc.

ORR for Epcoritamab 48mg (Cohort 2b Dose expansion part): 97.6

AbbVie Inc. โ€” Tepkinly EMA EPAR variation assessment report, p.71

Columvi

Roche Holding AG

737 cited findings on the drug page โ†’
Lynozyfic

Regeneron Pharmaceuticals, Inc.

686 cited findings on the drug page โ†’
Imdylltra

Amgen Inc.

607 cited findings on the drug page โ†’
Elrexfio

Pfizer Inc.

Overall Response Rate (ORR) by BICR: 75 (61.0) %

Pfizer Inc. โ€” Elrexfio FDA Review (BLA761345, ORIG 1, 2023), p.122

Lunsumio

Roche Holding AG

501 cited findings on the drug page โ†’
Tecvayli

Johnson & Johnson

390 cited findings on the drug page โ†’
Kimmtrak / tebentafusp

Immunocore

355 cited findings on the drug page โ†’

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Oncology research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

Bispecific T-cell engagers & bispecifics โ€” 11 Drugs Compared from FDA & EMA Reviews | BioPharmaPT Oncology