Onco-Summaries: Daily Oncology Updates at a Glance

19/09/2025

Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous administration (Ref)

The EMA's CHMP adopted a positive opinion recommending the approval of Merck & Co./MSD's pembro (anti-PD-1) mono as a neoadjuvant Tx followed by adjuvant pembro + RT ± cisplatin after surgery, then pembro mono for resectable locally advanced SCCHN with PD-L1 CPS ≥1. 

• The recommendation is based on results from the Ph3 KEYNOTE-689/NCT03765918 trial evaluating neoadjuvant pembro followed by adjuvant pembro + RT ± cisplatin vs upfront surgery followed by adjuvant RT ± cisplatin in newly diagnosed, stage III or IVA, resected, locally advanced SCCHN

  
  

Additionally, the CHMP also adopted a positive opinion for Keytruda SC (subcutaneous formulation of pembro + Alteogen's berahyaluronidase alfa, a variant of human hyaluronidase).

• Keytruda SC would be administered in one minute every three weeks (395 mg) or in two minutes every six weeks (790 mg)

  
  

• The positive opinion applies to all approved indications for adult pts in Europe

  
  

• The recommendation is based on results from the Ph3 MK-3475A-D77/NCT05722015 non-inferiority trial of subcutaneous pembro + chemotherapy vs pembro IV + chemotherapy as a first-line Tx of adult, metastatic NSCLC pts

Merck & Co/MSD's subcutaneous pembro product, Keytruda Qlex, has been approved by the US FDA (Ref)

The US FDA approved Merck & Co/MSD's Keytruda Qlex (pembrolizumab and Alteogen's berahyaluronidase alfa, a variant of human hyaluronidase) injection for subcutaneous administration in adults across most solid tumor indications for Keytruda.

• The approval is based on results from the Ph3 MK-3475A-D77/NCT05722015 non-inferiority trial of subcutaneous pembro + chemotherapy vs pembro IV + chemotherapy as a first-line Tx of adult, metastatic NSCLC pts

  
  

• Merck expects to have Keytruda Qlex available in the US in late September

  
  

• To note, Keytruda Qlex is contraindicated in pts with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients