Principal investigator of HARMONi-2, the trial where ivonescimab beat pembrolizumab head-to-head, and of the first EGFR-TKI phase 3 in Chinese patients.
Caicun Zhou is Professor of Medical Oncology at Shanghai Pulmonary Hospital, Tongji University, and a leader of the Chinese Thoracic Oncology Group. He led OPTIMAL, one of the first trials to prove that an EGFR tyrosine kinase inhibitor, erlotinib, beats chemotherapy in EGFR-mutant non-small-cell lung cancer, and it was the first EGFR-TKI phase 3 in Chinese patients. Two decades later he was principal investigator of HARMONi-2, in which the Akeso bispecific antibody ivonescimab, which targets PD-1 and VEGF, beat pembrolizumab head-to-head in first-line PD-L1-positive non-small-cell lung cancer. His publications include the HARMONi-2 and OPTIMAL trial reports, and his interests span EGFR inhibitors, immunotherapy and bispecific antibodies. He is President of the International Association for the Study of Lung Cancer for the 2025 to 2027 term and one of the most prolific lung cancer clinical investigators in China.
For the first time a new drug has beaten pembrolizumab, the global first-line standard, in a randomised lung cancer trial, and it did so by combining checkpoint blockade with anti-angiogenesis in one molecule. For patients outside China nothing changes yet: the drug is not approved in the West, the trial was single-country, and survival benefit has not been shown. If confirmed in the global HARMONi-3 and HARMONi-7 trials, PD-1 x VEGF bispecifics could replace PD-1 antibodies as the immunotherapy backbone.
Anyone diagnosed with advanced lung cancer should have EGFR testing before treatment, because osimertinib as the first drug gives the longest disease control, protects the brain, and is well tolerated. Chemotherapy is not the first step for these patients. The remaining questions are whether to intensify upfront (adding chemotherapy or amivantamab) and how to treat resistance when it develops.
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