.png)
Oncology Updates - Key Oncology News
- Oncofocus Team
- Aug 12, 2025
- 2 min read
August 2nd Week, 2025
Regulatory Events
🎯 The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (kinase inhibitor) for previously treated, unresectable/metastatic non-sqNSCLC with HER2 TKD activating mutations. (Ref 1)
❓ What proportion of NSCLC patients have HER2 TKD activating mutations?
🎯 The US FDA granted accelerated approval to Jazz Pharmaceuticals' dordaviprone (DRD2 antagonist and ClpP agonist) for previously treated, H3 K27M-mutant, diffuse midline glioma. (Ref 2)
❓ What are the other key assets being developed for this indication?
Clinical Events
🔬 The Phase 3 EPCORE FL-1 trial of Genmab and AbbVie's subcutaneous epcoritamab (CD20 x CD3 BsAb) + rituximab + lenalidomide (R2) vs R2 alone met its dual primary endpoints of ORR and PFS in R/R follicular lymphoma. (Ref 3)
❓ How do the outcomes compare against the benchmarks in R/R FL?
🔬 China's NMPA and the US FDA have approved the initiation of Akeso Biopharma's global, randomized Phase 2 COMPASSION-36 registrational trial of cadonilimab (PD-1 x CTLA-4 BsAb) + lenvatinib (multi-TKI) vs lenvatinib alone for the Tx of advanced hepatocellular carcinoma previously treated with atezolizumab and bevacizumab. (Ref 4)
❓ What is the rationale behind the study?
🔬 Immutep Limited received positive and constructive feedback from the US FDA regarding future clinical development of eftilagimod alpha (soluble LAG-3 protein) as a first-line Tx of R/M SCCHN with PD-L1 CPS <1. (Ref 5)
❓ What are the next steps for development of the LAG-3 agent in this indication?
Special Designations
⭐ The US FDA granted the Fast Track designation to ProteinQure's PQ203 (SORT1 targeting peptide drug conjugate) for the Tx of triple negative breast cancer. (Ref 6)
❓ What are the key unmet needs for this indication?
⭐ The US FDA granted the Fast Track designation to Dizal Pharmaceutical’s birelentinib (LYN/BTK dual inhibitor) for the Tx of R/R chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of Tx, including a BTK inhibitor and a BCL-2 inhibitor. (Ref 7)
❓ What were the outcomes that supported the designation?
Deal and Collaborations
🤝 SERB Pharmaceuticals and Y-mAbs Therapeutics, Inc. have entered into a definitive merger agreement under which SERB will acquire Y-mAbs, including its lead commercial oncology asset, naxitamab (anti-GD2). (Ref 8)
❓ Which other key developers have anti-GD2 assets in their pipeline?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References:
Comments