Oncology Updates - Key Oncology News

February 3rd Week, 2025

📝With the Ph3 CHECKMATE-816 trial meeting its key secondary endpoint of OS, BMS’ nivo + platinum-doublet CT became the first neoadjuvant-only Tx to significantly improve OS in resectable NSCLC patients. (Ref 1) 

❓Will the positive OS data support BMS’ regimen in tackling the competitive threat from the perioperative chemo-IO regimens?

📝The US FDA will be assessing BI's NDA of zongertinib (irreversible ERBB2 TKI) for previously treated, HER2+ve, unresectable or met NSCLC under the Priority Review designation with the PDUFA action date falling in Q3'25. (Ref 2) 

❓If approved, will the data package of zongertinib allow it to become the go-to Tx option for these patients?

📝 Based on discussions with the US FDA, Formycon terminated the Ph3 LOTUS trial of FYB206, a pembro biosimilar, in NSCLC, as the therapeutic comparability of FYB206 with pembro will be sufficiently demonstrated in the Ph1 Dahlia trial ongoing in Melanoma. (Ref 3) 

❓What impact will the potential entry of biosimilars have on the market share of pembro?

📝In the Ph1 Deltacel-01 trial, Kiromic’s Deltacel (gamma delta T-cell therapy) continued to show promising signals in previously treated NSCLC pts, with the fourth patient remaining progression-free at the 10 months follow-up. (Ref 4) 

❓What are the current benchmarks for PFS in previously treated NSCLC pts?

📝The Ministry of Food and Drug Safety approved a change to Abion Bio’s Ph2 study plan for vabametkib (c-MET TKI) + lazertinib (EGFR TKI) in advanced solid tumors including NSCLC patients with MET overexpression or amplification. The study will be conducted across sites in the US, Korea and Taiwan. (Ref 5) 

❓How is the TKI combination positioned in the landscape for MET amplified NSCLC?

📝Zydus entered a licensing, supply and commercialization agreement with Zhuhai Beihai Biotech for Beizray (albumin solubilized docetaxel injection) for the US market under which Beihai would oversee manufacturing and supply of the product, while Zydus would be responsible for its commercialization. (Ref 6) 

❓What is the addressable market size for Beizray in the US?

📝Innovent’s IBI363 (PD-1/IL-2 BsAb) received Fast Track Designation from the US FDA for unresectable, LA/met squamous NSCLC that progressed after anti-PD-L1 and platinum-based CT. (Ref 7) 

❓What are the outcomes of IBI363 that support the FTD, and how does it compare against the current benchmarks in this setting?

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🌐 References:

1) https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Announces-Opdivo-Plus-Chemotherapy-as-the-First-and-Only-Neoadjuvant-Only-Immuno-Oncology-Therapy-to-Demonstrate-Statistically-Significant-and-Clinically-Meaningful-Overall-Survival-in-Resectable-Non-Small-Cell-Lung-Cancer/default.aspx

2) https://www.boehringer-ingelheim.com/us/zongertinib-granted-priority-review-us-fda

3) https://www.formycon.com/en/blog/press-release/formycon-ag-informs-about-recent-developments-in-various-biosimilar-projects-and-invites-to-conference-call/

4) https://www.businesswire.com/news/home/20250218269453/en/Kiromic-BioPharma-Reports-Patient-4-in-Deltacel-01-Clinical-Trial-Reaches-10-Month-Progression-Free-Survival

5) https://abionbio.com/en/2025/02/19/abion-receives-approval-from-ministry-of-food-and-drug-safety-for-change-to-phase-2-clinical-trial-of-anticancer-drug-candidate-vabametkib/

6) https://zyduslife.com/investor/admin/uploads/21/83/Zydus-and-Beihai-Biotech-sign-an-exclusive-licensing--supply-and-commercialization-agreement-for-BEIZRAY-(Albumin-Solubilized-Docetaxel-Injection)--a-505(B)(2)-product-for-the-US-market.pdf

7) https://www.prnewswire.com/news-releases/innovent-receives-second-fast-track-designation-from-the-us-fda-for-ibi363-pd-1il-2-bias-bispecific-antibody-fusion-protein-in-squamous-non-small-cell-lung-cancer-302377632.html