Onco-Summaries: Daily Oncology Updates at a Glance

07/08/2025

ProteinQure's PQ203 received the Fast track designation for TNBC (Ref)

The US FDA granted the Fast Track designation to ProteinQure's PQ203 (SORT1 targeting peptide drug conjugate) for the treatment of patients with triple negative breast cancer.

• ProteinQure also received regulatory clearance from both the US FDA and Health Canada to initiate a Phase 1 trial evaluating the safety, pharmacokinetics, pharmacodynamics and anti-cancer activity of PQ203

  
  

• The Phase 1 study is expected to begin at Princess Margaret Cancer Centre, Toronto, with expansion to clinical sites in the US later this year

The Phase 3 EPCORE FL-1 trial met its dual primary endpoints in R/R FL (Ref)

The Phase 3 EPCORE FL-1 trial of Genmab and AbbVie's subcutaneous epcoritamab (CD20 x CD3 bispecific antibody) + rituximab + lenalidomide (R2) vs R2 alone met its dual primary endpoints of ORR and PFS for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL)

• The regimen demonstrated statistically significant and clinically meaningful differences in both endpoints, reducing the risk of disease progression or death by 79%

  
  

• The pre-planned interim analysis data will be submitted for presentation at the 67th ASH conference and will serve as the basis for global regulatory submissions