Onco-Summaries: Daily Oncology Updates at a Glance

25/11/2025

CStone Pharmaceuticals' sugemalimab received the EC approval for unresectable stage III NSCLC (Ref)

The European Commission  granted approval to CStone Pharmaceuticals' sugemalimab (anti-PD-L1) as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 ≥1% and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy.

• Dr. Jason Yang, CEO, President of R&D, and Executive Director, CStone: “Coming about a year after the initial EC approval for first-line metastatic NSCLC, this second approval expands the indication for sugemalimab to cover the full spectrum of the disease—from locally advanced, unresectable Stage III to metastatic Stage IV—across Europe. This provides a new treatment option for a broader patient population. CStone remains committed to enhancing the global accessibility of sugemalimab and fulfilling our long-term promise to patients.”

• Dr. Qingmei Shi, CMO, CStone: “With its approval as the second PD-(L)1 antibody in Europe for Stage III NSCLC, sugemalimab is poised to address a critical unmet medical need. This achievement was made possible by the exceptional efforts of our clinical development and regulatory teams, which facilitated the European Medicines Agency (EMA)’s smooth and quick review process. We are committed to further enhancing our global capabilities to deliver our innovative pipeline to patients around the world.”

AstraZeneca’s durvalumab + FLOT received FDA approval for resectable GC/GEJC (Ref)

The US FDA granted approval to AstraZeneca’s durvalumab (Imfinzi; anti-PD-L1) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.

• The approved regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy.

• The approval follows a Priority Review and is based on results from the Phase 3 MATTERHORN trial