Oncology Updates - Key Oncology News

Oncofocus Team
Jun 23
2 min read

June 1st Week, 2025

Regulatory Events

🎯 Takeda and Pfizer’s brentuximab vedotin (Adcetris; CD30 ADC) + ECADD chemo regimen has been approved by the European commission for the Tx of adult patients with newly diagnosed stage IIb with risk factors/III/IV Hodgkin lymphoma. (Ref 1)

❓ Can brentuximab-based regimen be the standard of care? What are its strengths and limitations?

🎯 Tempest Therapeutics’ amezalpat (selective PPAR⍺ antagonist) has been granted an Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the Tx of hepatocellular carcinoma. (Ref 2)

❓ What are the current Tx strategies and recent therapeutic advancements in HCC?

🎯 Innovent Biologics' IBI363 (PD-1 x IL-2α-bias BsAb fusion protein) has been granted a Breakthrough Therapy Designation by China's NMPA for the Tx of LA/M squamous NSCLC patients who have progressed on prior PD-(L)1 and platinum-based chemotherapy. (Ref 3)

❓ How do IBI363’s clinical efficacy compare with that of approved regimens? Can it be an acquisition target?

Clinical Developments

🔬 The Ph3 HARMONi trial of Summit Therapeutics, Inc. and Akeso Biopharma’s ivonescimab (PD-1 x VEGF BsAb) + platinum-doublet chemotherapy in EGFR+ve non-squamous NSCLC patients who have progressed on a 3rd gen-TKI demonstrated a statistically significant and clinically meaningful improvement in PFS. (Ref 4)

❓ What is the expected regulatory timeline for ivonescimab’s approval in the US and Europe?

Mergers & Collaborations

🤝 Vividion Therapeutics, Inc., a wholly owned and independently operated subsidiary of Bayer AG, acquired exclusive worldwide development and commercialization rights for VVD-214 (RO7589831; Werner helicase inhibitor), which was co-developed by Vividion and Roche. (Ref 5)