Onco-Summaries: Daily Oncology Updates at a Glance

14/10/2025

Pfizer's tucatinib combination regimen significantly improved PFS as a 1L maintenance therapy in HER2+ve metastatic Breast Cancer (Ref)

Per topline results from the Phase 3 HER2CLIMB-05 trial, Pfizer's tucatinib (tyrosine kinase inhibitor) in combination with first-line standard-of-care maintenance therapy (trastuzumab plus pertuzumab) following chemotherapy-based induction met its primary endpoint of PFS in HER2+ metastatic breast cancer.

• A statistically significant and clinically meaningful improvement in PFS by investigator assessment was achieved vs placebo arm

  
  

• The treatment was tolerable, with a safety profile generally consistent with the established safety profiles of each individual therapy

  
  

• Results from HER2CLIMB-05 will be presented at a future medical congress and discussed with regulatory authorities

Akamis Bio's NG-350A received the FDA fast track designation for pMMR, locally advanced rectal cancer (Ref)

The US FDA granted the fast track designation to Akamis Bio's NG-350A (oncolytic immunotherapy) for the treatment of pMMR, locally advanced rectal cancer.

• Oliver Rosen, CMO, Akamis Bio: “The NG-350A Fast Track designation from FDA is a recognition of the significant unmet need for new therapies to treat locally advanced rectal cancer (LARC). The global incidence of LARC continues to rise, with a particularly alarming increase of this cancer among younger populations. Patients with mismatch repair-proficient tumors account for approximately 90% of LARC cases, and this population has the greatest need for evolution in the standard of care to include treatments that may enable patients to avoid surgical interventions.”

  
  

• NG-350A is currently being evaluated in combination with chemoradiotherapy in the Phase 1b FORTRESS (NCT06459869) trial