On March 8th, Professor Zhou Caicun's team from the School of Medicine of Tongji University, along with its affiliated Shanghai East Hospital and Shanghai Pulmonary Hospital, published groundbreaking findings in the prestigious international medical journal The Lancet. The HARMONi-2 study highlighted the remarkable efficacy of the novel anti-cancer drug Ivonescimab in treating advanced non-small cell lung cancer (NSCLC). As the world's first Phase III HARMONi-2 study to show significantly superior outcomes compared to Pembrolizumab, this achievement offers new hope for patients with advanced lung cancer and provides crucial scientific evidence for oncology treatment, marking a major milestone in the development of anti-cancer therapies.

The nationwide, multicenter, randomized, double-blind, registrational Phase III clinical trial compared the efficacy and safety of Ivonescimab and Pembrolizumab in patients with PD-L1-positive advanced NSCLC. The results demonstrated that the median progression-free survival (mPFS) in the Ivonescimab group was 11.1 months—nearly double the 5.8 months observed in the Pembrolizumab group—with both statistical and clinical significance. Furthermore, the objective response rate (ORR) for Ivonescimab reached 50%, substantially higher than Pembrolizumab's 39%, underscoring its potent anti-tumor effects. These findings indicate that Ivonescimab represents a more effective treatment option for patients with advanced, driver gene-negative, PD-L1-positive NSCLC, especially for those requiring enhanced efficacy and survival or who are unsuitable for chemotherapy.

Professor Zhou Caicun's team emphasized their ongoing commitment to advancing research on Ivonescimab, including exploring its potential across various tumor types and in combination with other treatment modalities. Their goal is to further validate Ivonescimab’s efficacy and safety in a broader patient population.

The corresponding author of the paper is Professor Zhou Caicun, while the first authors are Associate Professor Xiong Anwen and Associate Senior Attending Physician Wang Lei, both from Tongji University School of Medicine. The research team also received substantial support from experts and scholars at hospitals nationwide, including Hunan Cancer Hospital, Harbin Cancer Hospital, The First Affiliated Hospital of Henan University of Science & Technology, and Shanghai Chest Hospital.

In recent years, Professor Zhou Caicun's team has made a series of significant advancements in anti-cancer drug development, particularly in novel drug therapies. Through continuous exploration of innovative treatments with unique mechanisms, the team has provided more precise and effective therapeutic options for lung cancer patients, contributing to improved survival outcomes and offering new hope for those affected by the disease.

Paper Link: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02722-3/abstract