Onco-Summaries: Daily Oncology Updates at a Glance

30/07/2025

Phase 3 COSTAR Lung trial of dostarlimab + docetaxel ± cobolimab failed to meet the OS endpoint in previously treated NSCLC (Ref)

GSK's Phase 3 COSTAR Lung/NCT04655976 trial of dostarlimab (anti-PD-1) + docetaxel ± cobolimab (anti-TIM-3) combinations did not meet the primary endpoint of improving OS vs docetaxel alone in advanced NSCLC that has progressed on prior PD-(L)1 therapy and chemotherapy.

• All regimens were well tolerated and toxicities were consistent with known safety profiles of docetaxel and ICIs

Astellas terminated the Ph2 EV-202 trial of enfortumab vedotin (anti-Nectin-4 ADC) + pembro in PD-L1 CPS ≥1, R/M SCCHN pts (Ref)

Astellas revealed the termination of the Ph2 EV-202/NCT04225117 basket trial of Pfizer & Astellas’ enfortumab vedotin (anti-Nectin-4 ADC) + pembro as a first-line Tx of PD-L1 CPS ≥1, R/M SCCHN, in their Q1'25 financial updates.

• The decision to terminate the trial was based on a comprehensive review of data generated

• The termination would be applicable to all cohorts of other solid tumors

Sanofi's SAR446523 received the FDA orphan drug designation for multiple myeloma (Ref)

The US FDA granted the orphan drug designation to Sanofi's SAR446523 (anti-GPRC5D) for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM).

• GPRC5D is highly expressed on plasma cells in MM patients, with low expression in healthy tissues

  
  

• Alyssa Johnsen, Global Therapeutic Area Head, Immunology and Oncology Development, Sanofi: “The orphan drug designation is a significant milestone in our ongoing efforts to develop innovative treatments in multiple myeloma. This underscores our commitment to multiple myeloma, a disease for which we have acquired strong expertise with the development of another widely used and approved immunotherapy treatment.”