Onco-Summaries: Daily Oncology Updates at a Glance

29/10/2025

Merck's perioperative Keytruda regimen received approval from the EC for LA SCCHN with PD-L1 CPS ≥1 (Ref)

The European Commission (EC) has approved Merck & Co./MSD's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT with or without cisplatin after surgery, and then as a single agent for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1.

• The approval follows a positive CHMP opinion, and is based on results from the Ph3 KEYNOTE-689/NCT03765918 trial evaluating neoadjuvant pembro followed by adjuvant pembro + RT ± cisplatin (n=363) vs upfront surgery followed by adjuvant RT ± cisplatin (n=351) in newly diagnosed, stage III or IVA, resected, locally advanced SCCHN

  
  

• Dr. Marjorie Green, SVP and Head of oncology, Global clinical development, Merck Research Laboratories: “This approval brings a promising advancement to patients in Europe with resectable locally advanced head and neck squamous cell carcinoma. We’re proud of the continued progress we’re making to broaden the impact of KEYTRUDA in head and neck cancers and remain focused on working to deliver innovative approaches that have the potential to make a meaningful difference for patients.”

The Phase 3 LEAP-012 trial of pembrolizumab + lenvatinib + TACE failed to meet the OS endpoint in HCC (Ref)

Merck and Co./MSD and Eisai reported that the Phase 3 LEAP-012 trial of pembrolizumab (anti-PD-1) + lenvatinib (multiple receptor TKI) + TACE did not achieve statistical significance for OS vs TACE alone for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC).

• The likelihood of reaching the protocol-specified threshold for statistical significance for OS at a future analysis was evaluated by Merck and Eisai and considered to be low

  
  

• On this basis, the study will be closed, and the companies are informing investigators of this decision

  
  

• The safety profile of the regimen was consistent with that observed in previously reported studies evaluating the combination and in earlier analyses of LEAP-012

Dewpoint Therapeutics' DPTX3186 received the FDA orphan drug designation for gastric cancer (Ref)

The US FDA granted the orphan drug designation to Dewpoint Therapeutics' DPTX3186 (oral condensate modulator) for the treatment of gastric cancer.

• Isaac Klein, CSO and Head of R&D, Dewpoint Therapeutics: “The FDA’s decision to grant Orphan Drug Designation to DPTX3186 is an extraordinary validation of both the promise of condensate biology and the importance of our work in gastric cancer. This recognition reflects the agency’s confidence in our mechanism, our science, and our shared goal of bringing new hope to patients facing this devastating disease.”