Lung Cancer Drug Ivonescimab Cuts Risk of Death by 27%, Extends Survival by 8 Months

Ivonescimab, an immuno-oncology drug developed by Chinese pharmaceutical company Akeso, reduced the risk of death by 27% as a first-line treatment for PD-L1-positive non-small cell lung cancer, according to Phase 3 results.

According to the Korea Biotechnology Industry Organization’s Bioeconomy Research Center, Akeso said in a news release on June 13 that it would present overall survival (OS) results from the HARMONi-2 study at the 2026 World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer (IASLC) at COEX in Seoul.

This randomized, double-blind, multicenter registrational Phase 3 trial compared ivonescimab with pembrolizumab as first-line treatment in patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer.

The trial found that ivonescimab reduced the risk of death by 27% compared with Keytruda (generic name, pembrolizumab) in patients with previously untreated PD-L1-positive advanced non-small cell lung cancer.

Median OS was 30.8 months in the ivonescimab group and 22.6 months in the pembrolizumab group (P=0.009).

The results were selected as a late-breaking abstract (LBA) for oral presentation and were also included in the official WCLC press program.

Abstract data on OS from HARMONi-2 were posted on the official WCLC website on June 13. On June 15, the study’s principal investigator, Zhou Caichun, chief of medical oncology at Shanghai East Hospital, is scheduled to give the official oral presentation at the conference. Zhou is president of the IASLC.

HARMONi-2 is the first randomized, double-blind, controlled Phase 3 trial to demonstrate statistically significant positive results for both OS and progression-free survival (PFS) compared with pembrolizumab.

An international, multicenter Phase 3 trial (HARMONi-7) comparing ivonescimab monotherapy with pembrolizumab in patients with PD-L1-high non-small cell lung cancer is also underway.

Akeso said, “Ivonescimab has consistently achieved positive results for both OS and PFS in multiple Phase 3 head-to-head trials against PD-1/L1 inhibitors,” adding that it “is continuing to expand its indications beyond lung cancer to major solid tumors.”