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Tanja Obradovic

May 9, 2025, 11:28

Tanja Obradovic Highlights Ivonescimab’s Phase III Entry in Pancreatic Cancer

Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, posted on LinkedIn:

“New frontier is opening in unresectable metastatic pancreatic ductal adenocarcinoma (PDAC) with Ivonescimab, a PD-1/VEGF inhibitor that is just about to start Phase III trial in the frontline.

While Ivonescimab is under scrutiny for outcome in NSCLC where critical OS data is to come, opening of the development within PDAC is quite significant considering very high unmet need and opening considering well established PD(L)1 inhibitors.

Few aspects to note about starting strategy by Akeso Biopharma in PDAC. Just incoming Phase III will be only in China, similar to the path used for NSCLC so questions about outcomes will be similar in terms of global relevancy as well as FDA position once submitted.

Ivonescimab is already tested in four other smaller China trials (Phase I and PhII) in the earlier stage of pancreatic cancer leaving possibility of future global placement within that space too depending on outcome readouts in leading lung program and possible fast data maturity in China pancreas portfolio.

Outcomes that will be under close watch by oncology community would be efficacy as well as safety profile especially on Phase III study where quite heavy load on top of the chemo backbone will be tested by going beyond adding only Ivonescimab. Three treatments will be: Ivonescimab with chemo (Paclitaxel + Gemcitabine), Ivonescimab with chemo and AK117, a next generation CD47 monoclonal antibody, and chemo alone with placebo.”

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