Onco-Summaries: Daily Oncology Updates at a Glance

12/06/2025

MAIA Biotechnology and Roche announce a master clinical supply agreement for hard-to-treat cancer therapies (Ref)

• MAIA Biotechnology entered into a clinical master supply agreement with Roche for future trials evaluating MAIA’s ateganosine (THIO; telomere-targeting agent) in combination with Roche's atezolizumab (Tecentriq; anti-PD-L1) for the treatment of multiple hard-to-treat cancers.

  
  

• Ateganosine's highly synergistic and effective activity in combination with atezolizumab in preclinical studies was the basis of this agreement.

  
  

  • Vlad Vitoc, Chairman and CEO, MAIA: “In preclinical studies, ateganosine was found to be highly synergistic and effective in combination with Roche’s anti-PD-L1 agent atezolizumab. We are pleased to partner with world-renowned Roche and we look forward to further strengthening our mission to find safe and effective cancer treatments.”

Alligator's Phase 3 trial of mitazalimab received positive scientific advice from the EMA (Ref)

• The European Medicines Agency (EMA) provided positive scientific advice supporting the overall design of the planned Phase 3 trial of Alligator Bioscience's mitazalimab (stimulatory antibody targeting CD40) in metastatic pancreatic cancer.

  
  

• The advice confirms that the study of mitazalimab + mFOLFIRINOX is appropriately designed to support future marketing authorization application.

  
  

• Alligator is continuing preparations for the trial initiation in line with regulatory inputs.

• Søren Bregenholt, CEO, Alligator Bioscience: “We are very pleased with EMA’s endorsement of our Phase 3 trial design and mitazalimab’s Phase 3 readiness, confirming its path to regulatory approval in Europe. This advice from EMA aligns very well with previous input from FDA thus enabling a single global Phase 3 study leading to mitazalimab’s potential registration as a new treatment for patients with metastatic pancreatic cancer in these major territories.”

Merck & Co./MSD's neoadjuvant pembro followed by adjuvant pembro + RT ± cisplatin has been approved in the US for PD-L1 CPS ≥1 pts (Ref)

• The US FDA approved pembrolizumab (Keytruda; 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 has been granted based on a priority review of the 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.

  
  

  • Key outcomes in the PD-L1 CPS ≥1 pts (who accounted for ~95% of the enrolled population):

    • mEFS: 59.7 mos vs 29.6 mos (HR 0.70, 95% CI 0.55 - 0.89; p=0.0014)

    • MPR: 9.8% vs 0.0%

    • pCR: 3.2% vs 0.0%

• The marketing authorization applications are also under review by regulatory authorities worldwide, including Europe and Japan.