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Oncology Updates - Key Oncology News

May 4th Week, 2025



Regulatory Events 



🎯 The US FDA granted a Fast Track designation to CSPC Pharmaceutical Group ’s CPO301 (SYS6010; EGFR ADC) for the Tx of oncogenic driver mutation negative, non-squamous NSCLC patients who have progressed on prior platinum chemotherapy and anti-PD-(L)1 therapy. (Ref 1)


❓ Which other ADCs are being developed for this setting?

 


🎯 Zai Lab's ZL-1310 (DLL3 ADC) was granted a Fast Track designation by the US FDA for the Tx of ES-SCLC patients who have progressed on prior platinum-based chemotherapy. (Ref 2)


❓ What is the current SoC for ES-SCLC Tx?

 


🎯 The EMA granted a pediatric study waiver to Alligator Bioscience AB’ mitazalimab (CD40 agonist) for the Tx of pancreatic cancer. (Ref 3)


❓ How do pediatric study waivers accelerate timelines for therapies like mitazalimab?

 


🎯 China’s NMPA approved Jacobio Pharma’s glecirasib (KRAS G12C inhibitor), which was outlicensed to Shanghai Allist Pharmaceuticals Co., Ltd in China, for the Tx of KRAS G12C mutated NSCLC patients who have progressed on at least one prior systemic therapy. (Ref 4)


❓ How does it compare against other approved assets in this setting?



Clinical Events 



🔬 The Ph3 TALENTACE trial of Roche’s atezolizumab (Tecentriq; anti-PD-L1) + Roche’s bevacizumab (Avastin; anti-VEGF) + on-demand transarterial chemoembolization (TACE) in previously untreated HCC patients, conducted by Chugai Pharmaceutical Co., Ltd. in China and Japan, met its primary endpoint of TACE PFS. (Ref 5)


❓ Is a similar treatment regimen currently being investigated in global clinical trials?



Deals & Collaborations



🤝 In >$6.0 billion deal ($1.25 upfront), Pfizer gained global (ex-China) rights for 3SBio Inc.’s SSGJ-707 (PD-1 x VEGF BsAb) (Ref 6)


❓ What clinical data are available for SSGJ-707, and how do its outcomes compare to other PD-1 x VEGF BsAbs?



🤝 Antengene and Merck & Co/MSD entered into a global clinical collaboration agreement to evaluate Antengene's ATG022 (CLDN18.2 ADC) in combination with Merck & Co/MSD’s pembrolizumab (Keytruda; anti-PD-1) in advanced solid tumors. (Ref 7)


❓ What are the potential therapeutic indications for this regimen?



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



🌐 References:


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