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Oncology Updates - Key Oncology News

April 1st Week, 2025



Regulatory Events


🎯 AstraZeneca's neoadjuvant durvalumab (anti-PD-L1) + chemo followed by adjuvant durvalumab mono has been approved for adults with resectable NSCLC at a high risk of recurrence and no EGFR mutations or ALK rearrangements in the EU. (Ref 1) 


❓ What are the other approved regimens in the early-stage NSCLC, and how do the outcomes of the AEGEAN regimen compare against those regimens? 



🎯 The US FDA approved AstraZeneca’s neoadjuvant durvalumab + gemcitabine + cisplatin followed by adjuvant durvalumab mono for adults with muscle invasive bladder cancer. (Ref 2) 


❓ What is the addressable market size for this perioperative regimen? 



Special Designations 



⭐ IDEAYA Biosciences’ darovasertib (PKC inhibitor) has been granted the breakthrough therapy designation by the US FDA for the neoadjuvant Tx of primary uveal melanoma for whom enucleation has been recommended. (Ref 3) 


❓ What are the outcomes of darovasertib that supported the breakthrough therapy designation? 



⭐ Innovent Biologics’ IBI363 (PD-1 x IL-2α-bias BsAb) has been granted the breakthrough therapy designation by China’s NMPA for previously untreated mucosal/acral melanoma. (Ref 4) 


❓ Do the outcomes of IBI363 have the potential to make it the SOC for these patients?



Clinical Events 



🔬 The Phase 3 ROSELLA trial of Corcept Therapeutics’ relacorilant (selective GR antagonist) + chemo met its primary endpoint of PFS in patients with platinum-resistant ovarian cancer. (Ref 5) 


❓ What are the unmet needs of platinum-resistant ovarian cancer, and does the Corcept’s regimen have the potential to address them? 



🔬 The Ph2/3 COMPANION-002 trial of Compass Therapeutics Inc.’s tovecimig (DLL4 x VEGF-A BsAb) + paclitaxel elicited statistically significant benefit in the primary endpoint of ORR vs paclitaxel alone in patients with unresectable advanced, metastatic or recurrent biliary tract cancers who have received one prior chemo regimen. (Ref 6) 


❓ What are the current ORR benchmarks for biliary tract cancer patients treated in the second-line setting? 



Setbacks 



🛑 The Phase 3 AdvanTIG-302 trial of BeiGene’s ociperlimab (anti-TIGIT) + tislelizumab (anti-PD-1) in NSCLC with PD-L1 ≥50% was terminated as it was unlikely to meet the primary endpoint of OS. As a result, the TIGIT program has been discontinued. (Ref 7) 


❓ What are the other recent setbacks in the TIGIT space? And are there any other noteworthy TIGIT assets that continue to be evaluated in large Phase 3 trials? 



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



🌐 References:


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