TNB-383B
- Generic Name
- TNB-383B
- Drug Type
- Biotech
- Background
TNB-383B is a CD3 and B-cell maturation antigen T-cell engaging bispecific antibody.
AbbVie's Telisotuzumab Vedotin Shows Promise in c-Met Overexpressing NSCLC
• AbbVie's telisotuzumab vedotin (Teliso-V) demonstrated a 35% overall response rate in patients with high c-Met expression in the LUMINOSITY trial.
• The FDA granted breakthrough therapy designation to Teliso-V, highlighting its potential to significantly improve outcomes in NSCLC patients.
• A phase 3 trial (TeliMET-NSCLC-01) is underway, comparing Teliso-V to docetaxel in c-Met-positive, non-squamous NSCLC patients.
• Teliso-V targets c-Met, a protein involved in cancer progression and resistance to therapies like EGFR inhibitors, offering a novel approach.
FDA to Review Belantamab Mafodotin and Linvoseltamab Combinations for Multiple Myeloma
• The FDA has accepted a BLA for belantamab mafodotin combinations with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for multiple myeloma treatment.
• Regeneron's linvoseltamab BLA resubmission has been accepted by the FDA, with a decision expected by July 10, 2025, for relapsed/refractory multiple myeloma.
• Clinical trials DREAMM-7 and DREAMM-8 support the belantamab mafodotin BLA, while LINKER-MM1 supports the linvoseltamab BLA, showcasing improved progression-free survival.
• Both belantamab mafodotin and linvoseltamab are under review by other regulatory authorities, potentially expanding treatment options for multiple myeloma patients.
AbbVie Seeks Accelerated FDA Approval for Telisotuzumab Vedotin in c-Met Overexpressing NSCLC
• AbbVie has submitted a Biologics License Application (BLA) to the FDA for telisotuzumab vedotin to treat NSCLC with c-Met protein overexpression.
• The BLA is supported by Phase 2 LUMINOSITY trial data, which showed promising overall response rates in c-Met high and intermediate patients.
• Telisotuzumab vedotin, an antibody-drug conjugate, targets c-Met-overexpressing tumors and could be a first-in-class therapy if approved.
• The FDA previously granted Breakthrough Therapy Designation to telisotuzumab vedotin, and a Phase 3 trial is underway to confirm its efficacy.
Bispecific Antibodies Teclistamab and Talquetamab Show Promise in Multiple Myeloma Treatment
• Teclistamab and talquetamab, bispecific antibodies, demonstrate efficacy in relapsed/refractory multiple myeloma by reducing soluble BCMA levels in responding patients.
• A reduction in sBCMA levels correlates with the depth of treatment response, with complete or stringent complete responses showing nearly 100% sBCMA reduction.
• Baseline sBCMA levels correlate with tumor burden, suggesting sBCMA as a potential marker, and do not significantly affect teclistamab exposure, indicating maintained clinical activity.
• Clinical trials are underway to evaluate bispecific antibodies in earlier lines of therapy and maintenance settings, potentially transforming myeloma treatment.
Drug Development Updates
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