Onco-Summaries: Daily Oncology Updates at a Glance

18/08/2025

Izalontamab brengitecan received the Breakthrough Therapy Designation by the US FDA for EGFR-mutated NSCLC (Ref)

The US FDA granted the Breakthrough Therapy Designation to SystImmune and Bristol Myers Squibb's izalontamab brengitecan (EGFR x HER3 bispecific ADC) for the treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI and platinum-based chemotherapy.

• To note, iza-bren is being developed by Biokin in China and jointly developed by SystImmune and Bristol Myers Squibb in territories outside of China

  
  

• The designation was granted based on data from three ongoing clinical trials - BL-B01D1-101 and BL-B01D1-203 (both conducted in China by Biokin), and the global BL-B01D1-LUNG-101 trial (conducted by SystImmune across the US, EU and Japan)

Ifinatamab deruxtecan received the Breakthrough Therapy Designation by the US FDA for extensive-stage SCLC (Ref)

The US FDA granted the Breakthrough Therapy Designation to Daiichi Sankyo and Merck & Co./MSD’s ifinatamab deruxtecan (anti-B7-H3 ADC) for the treatment of adult patients with extensive-stage SCLC with disease progression on or after platinum-based chemotherapy.

• The designation was granted based on data from the Phase 2 IDeate-Lung01 trial, with support from the Phase 1/2 IDeate-PanTumor01 trial

  
  

• To note, results from the primary analysis of IDeate-Lung01 will be presented in a late-breaking oral presentation at WCLC 2025 

Iovance's lifileucel received conditional market authorization by Health Canada for previously treated advanced Melanoma (Ref)

Health Canada issued a Notice of Compliance with Conditions (NOC/c) for Iovance Biotherapeutics' lifileucel (Amtagvi; autologous TIL therapy) for the treatment of adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor, and who have no satisfactory alternative treatment options.

• Market authorization was granted based on safety and efficacy results from the Phase 2 C-144-01 trial 

  
  

• To note, the market authorization is conditional, pending the results of trials to confirm its clinical benefit