Tanja Obradovic, Senior Advisor of Oncology Drug Development at HopeAI, Consultant, Oncology Drug Development at Arc Nouvel Clinical Development Consulting, and Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:
“Landscape of ongoing and opening Phase III trials of anti-PD-1 x VEGF bispecifics just became even busier with newcomer Pfizer just announcing start of three PF-08634404 trials -NCT07226999 in the first line extensive-stage small cell lung cancer (ES-SCLC), NCT07222800 in the first line colorectal (CRC), and NCT07222566 in the first line non-small cell lung cancer (NSCLC).
Ivonescimab, anti-PD-1 x VEGF bispecific sponsored by Akeso and Summit, already has substantial Phase III program getting high attention from oncology community this year with nine trials – NCT07010263 (consolidation treatment limited stage SCLC who have not progressed following concurrent chemoradiation therapy), NCT06767514 (Harmoni-7) first line NSCLC, NCT05899608 (Harmoni-3) first line NSCLC, NCT06928389 second line NSCLC post PD(L)-1 inhibitors, NCT07228832 in the first line colorectal (CRC), NCT06953999 in the first line pancreatic cancer (PDAC), NCT05184712 and NCT06396065 in the second line NSCLC post EGFR-TKI failure, NCT07076693 in second line oligoprogressive NSCLC.
Pumitamig, anti-PD-1 x VEGF bispecific sponsored by BioNTech, like PF-08634404 has three announced or ongoing PhIII trials- NCT07221149 in the first line gastric, gastroesophageal junction, or esophageal adenocarcinoma, NCT06712316 in the first line NSCLC, NCT07221357 in the first line CRC and NCT07173751 in the first line triple-negative breast cancer (TNBC) in PDL-1 negative disease.
Based on the current state, all three major players are overlapping in targeting NSCLC, SCLC and CRC with many additional overlaps in the Phase III likely considering rich Phase II pipelines in other tumors. Several of recruiting and announced studies have very aggressive projections of enrollment time and finishing.
Attention of oncology community on progress is certain to be there as well as evaluating emerging reports on safety and efficacy profiles especially of combinations. Also critical is potential of the class to demonstrate significant OS benefit in head-to-head comparison to relevant SOC already communicated by FDA as mandatory.
With Summit Therapeutics pushing through with a regulatory application to FDA for ivonescimab scheduled this last quarter of 2025 despite not reaching OS benefit in second-line EGFR-mutated NSCLC patients outside of China but obtaining larger pool of ex China data, updated feed back from regulators is certainly going to be informative.”
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