Onco-Summaries: Daily Oncology Updates at a Glance

28/07/2025

sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy for sqNSCLC accepted by China's NMPA (Ref)

The National Medical Products Administration (NMPA) has accepted the sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy as a first-line treatment for advanced squamous NSCLC.

• The filing is based on the results from the Phase 3 AK112-306/HARMONi-6 trial, which showed that ivonescimab + chemotherapy was superior to tislelizumab + chemotherapy

  
  

• This is the third submission accepted for ivonescimab in China, following previous filings for EGFR-TKI resistant locally advanced or metastatic non-squamous NSCLC, and first-line treatment of PD-L1 positive advanced NSCLC

Perioperative durvalumab + chemo accepted for Priority review by the US FDA for resectable early-stage gastric and gastroesophageal junction cancers (Ref)

The US FDA accepted and granted Priority Review to AstraZeneca’s sBLA for durvalumab (Imfinzi; anti-PD-L1) regimen for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.

• The sBLA was submitted based on results from the Phase 3 MATTERHORN trial of neoadjuvant durvalumab + chemotherapy before surgery, followed by adjuvant durvalumab + chemotherapy, then durvalumab monotherapy vs chemotherapy alone

  
  

  • mEFS: NR vs 32.8 months (HR 0.71; p<0.001)

    
    

• The PDUFA action date is anticipated during the Q4'25

  
  

• The regimen was also granted the Breakthrough Therapy Designation by the FDA in this setting

MAIA Biotechnology's ateganosine received Fast Track designation for NSCLC (Ref)

The US FDA granted the Fast Track designation to MAIA Biotechnology's ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of NSCLC.

• Ateganosine is currently being evaluated in a pivotal Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a CPI

  
  

• In the Phase 2 THIO-101 clinical trial, ateganosine (as of May 15, 2025) elicited a mOS of 17.8 months in a heavily pre-treated population

  
  

• Vlad Vitoc, Chairman and CEO, MAIA: “FDA’s Fast Track Designation recognizes ateganosine’s potential as a new therapeutic paradigm in cancer treatment science. Ateganosine is the first and only anticancer treatment of its kind that we are aware of in clinical development. If we are successful in the Fast Track regulatory pathway, ateganosine could qualify for accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year. If approved, ateganosine would have a first-to-market competitive position within a $34 billion NSCLC treatment market with significant unmet medical need."

Exelixis discontinued the Ph2/3 STELLAR-305 trial of zanzalintinib + pembro in PD-L1 CPS ≥1, R/M SCCHN (Ref)

Exelixis revealed the discontinuation of the Ph2/3 STELLAR-305 trial of zanzalintinib (multi-targeted TKI of VEGFR, MET, and the TAM kinases) + pembro vs placebo + pembro as a first-line Tx for PD-L1 CPS ≥1, R/M SCCHN, in their Q2'25 financial update.

• The decision to not proceed to the Ph3 part of STELLAR-305 was based on emerging Ph2 data, competition in SCCHN, and assessment of other potentially larger commercial opportunities 

• Detailed results from the Ph2 part of the trial remain undisclosed

  
  

• Michael M. Morrissey, President and CEO, Exelixis: “Based on our evaluation of emerging data from the Phase 2 portion of the STELLAR-305 study in advanced squamous cell carcinoma of the head and neck, emerging competition in this indication and assessment of other potentially larger commercial opportunities, we have made the decision not to proceed to the phase 3 portion of the trial.”