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Oncology Updates - Key Oncology News

April 3rd Week, 2025



Regulatory Events 



🎯 Bristol Myers Squibb’s nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the US FDA as a first-line Tx of unresectable/metastatic hepatocellular carcinoma. (Ref 1) 


❓ What portion of the first-line HCC patients are anticipated to transition to the nivolumab + ipilimumab regimen?




🎯 ImmunityBio, Inc. completed the sBLA submission to the US FDA for nogapendekin alfa inbakicept (IL-15 superagonist fusion protein) + BCG in BCG-unresponsive NMIBC in the papillary indication in Q1'25. (Ref 2) 


❓ What are the estimated launch timelines for nogapendekin alfa inbakicept in this indication? 



Special Designation 



⭐ The US FDA granted the fast-track designation to Accent Therapeutics, Inc. ’ ATX-295 (KIF18A inhibitor) for the Tx of advanced/metastatic platinum-resistant or refractory ovarian cancer, and ATX-559 (DHX9 inhibitor) for the Tx of unresectable/metastatic dMMR/MSI-H colorectal cancer post checkpoint inhibitor Tx. (Ref 3) 


❓ What are the outcomes of ATX-295 and ATX-559 that supported the fast-track designations?




⭐ The US FDA granted the fast-track designation to Prescient Therapeutics’ PTX-100 (GGT-1 inhibitor) for the Tx of relapsed or refractory mycosis fungoides. (Ref 4) 


❓ What is the landscape overview of assets currently in development for this indication?


 

⭐ The US FDA granted the breakthrough device designation to Alibaba’s DAMO PANDA artificial intelligence system for early pancreatic cancer detection. (Ref 5) 


❓ Which other companies are developing such AI-powered tools? 



Clinical Events 



🔬 In the Phase 3 DeLLphi-304 trial, Amgen’s tarlatamab (DLL3 x CD3 bispecific T-cell engager) met its primary endpoint of OS vs local SOC chemo in SCLC patients who progressed on or after a single line of platinum-based chemo. (Ref 6) 


❓ What is the current OS benchmark for SCLC patients treated in the second-line setting? 



Setbacks 



🛑 Based on the review of data from the Phase 2 ARTISTRY-6 trial in melanoma and results from the Phase 3 ARTISTRY-7 trial in platinum-resistant ovarian cancer, Mural Oncology discontinued the clinical development of its nemvaleukin alfa (modified IL-2 cytokine). (Ref 7) 


❓ What were the shortcomings in the Phase 2 and Phase 3 outcomes that led to the discontinuation?



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



🌐 References:


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