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Oncology Updates - Key Oncology News

September 1st Week, 2025



Regulatory Events



🎯 China’s NMPA approved Boehringer Ingelheim’s zongertinib (HER2-selective tyrosine kinase inhibitor) monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have activating HER2 mutations and who have received at least one line of prior systemic therapy. (Ref 1)


❓ What is the development status of the regimen in other key geographies?



Clinical Events 



🔬 The pivotal Phase 3 Dynasty-Breast01/NCT06265428 trial of BioNTech SE and Duality Biologics' trastuzumab pamirtecan (BNT323/DB-1303; HER-2 ADC) vs trastuzumab emtansine met its primary endpoint of PFS at a pre-specified interim analysis in patients with HER2+ve, unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy. (Ref 2)


❓ How is this readout expected to impact the Tx paradigm?



🔬 Replimune announced that a Type A meeting with the US FDA has been scheduled to discuss the CRL for the BLA of vusolimogene oderparepvec (RP1; herpes simplex virus engineered and genetically armed with GALV-GP R- and GM-CSF) + nivolumab for the treatment of advanced melanoma. (Ref 3)


❓ What are the key unmet medical needs for this indication?



Special Designations 



⭐ The US FDA granted the Breakthrough Therapy Designation to Boehringer Ingelheim's zongertinib (HER2-selective tyrosine kinase inhibitor) for the first-line treatment of adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 tyrosine kinase domain activating mutations. (Ref 4)


❓ What are the clinical outcomes that support the breakthrough therapy designation?



⭐ The US FDA granted the Breakthrough Therapy Designation to Eli Lilly and Company's olomorasib (KRAS G12C inhibitor) + Merck & Co/MSD's pembrolizumab (anti-PD-1), for the first-line treatment of unresectable advanced or metastatic NSCLC with a KRAS G12C mutation and PD-L1 expression ≥ 50%. (Ref 5)


❓ Which are the other key regimens with special designations in this indication?



⭐ The US FDA granted the Fast Track Designation to CERo Therapeutics, Inc.'s CER-1236 (TIM-4 ligand targeting CER-T therapy) for the treatment of Acute Myeloid Leukemia (AML). (Ref 6)


❓ Who are the other key players developing novel cell therapies for AML?



To know answers to these questions and for additional insights, write to us at support@oncofocus.com. 



🌐 References:


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