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Oncology Updates - Key Oncology News

May 3rd Week, 2025



Regulatory Events 



🎯 Incyte and MacroGenics, Inc.’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel has been approved by the US FDA for the first-line Tx of inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). Retifanlimab has also been approved as a single agent for the Tx of locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemo. (Ref 1) 


❓ What is the status of the other anti-PD-1 based regimens in this cancer type?



🎯 AbbVie’s telisotuzumab vedotin (anti- c-Met ADC) has been granted accelerated approval by the US FDA for the Tx of locally advanced or metastatic, non-squamous NSCLC with high c-Met protein overexpression, and who have received a prior systemic Tx. (Ref 2) 


❓ How will this approval impact the Tx paradigm of the indication? 


 

Clinical Events 



🔬 The Phase 3 KEYNOTE-B96 trial of Merck & Co./MSD’s pembrolizumab (anti-PD-1) + chemo ± bevacizumab met its primary endpoint of PFS for the Tx of platinum-resistant recurrent ovarian cancer patients whose tumors expressed PD-L1 and in all comers, and secondary endpoint of OS in patients whose tumors express PD-L1. (Ref 3) 


❓ What are the current PFS and OS benchmarks in this indication?

 


🔬 The Phase 3 RC48-C016 trial of Pfizer and RemeGen Biosciences’ disitamab vedotin (anti-HER2 ADC) + toripalimab (anti-PD-1) met its primary endpoints of PFS and OS vs chemotherapy as a first-line Tx for HER2+ve, locally advanced or metastatic, urothelial carcinoma. (Ref 4) 


❓ Which are the other anti-HER2 ADCs being developed for this indication? 



Special Designations 



⭐ The US FDA granted the orphan drug designation to Thermosome’s THE001 (thermosensitive liposomal formulation of doxorubicin) for the treatment of soft tissue sarcomas. (Ref 5) 


❓ What are the key unmet needs of patients with soft tissue sarcomas? 



Setbacks 



🛑 iTeos Therapeutics and GSK terminated the belrestotug (anti-TIGIT) development program and ended their collaboration based on disappointing results from the Ph2 GALAXIES Lung-201 and the Ph2 GALAXIES H&N-202 trials. (Ref 6) 


❓ Which other anti-TIGIT agents continue to be evaluated in solid tumors? 



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



🌐 References: 



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