HARMONI-2 Demonstrating “Significant” Improvement in PFS With Ivonescimab Over Pembrolizumab

Ivonescimab has demonstrated a “statistically significant and clinically meaningful improvement” in progression-free survival over pembrolizumab (Keytruda) for patients with first-line non–small cell lung cancer (NSCLC), according to data presented at the IASLC World Conference on Lung Cancer in San Diego, held September 7-10, 2024.¹

The data, from the HARMONi-2 (AK112-303) clinical trial, could mean a new first-line treatment option for these patients, the researchers, from Shanghai Pulmonary Hospital, Tongji University School of Medicine, in Shanghai, China, and others concluded in their study abstract.

Caicun Zhou, PhD, MD, of Shanghai Pulmonary, presented the data at the meeting, noting that 398 patients who had untreated locally advanced or metastatic NSCLC were randomly assigned in a 1:1 ratio, with 198 in the ivonescimab arm, to receive either 20 mg/kg of ivonescimab or 200 mg of pembrolizumab every 3 weeks.

The median progression-free survival was 11.14 months with ivonescimab and 5.85 months with pembrolizumab (HR, 0.51; 95% CI, 0.38-0.69; P<.0001) and was consistent across subgroups of patients, including those with higher PD-L1 tumor scores, with squamous and nonsquamous NSCLC, and with brain metastases.

“This is a historic moment for ivonescimab, Team Summit, our partners at Akeso, and most importantly, we believe this is the beginning of a paradigm change for treatment options for patients living with cancer,” Robert W. Duggan, Chairman and Chief Executive Officer of Summit, said in May.

References

1. Zhou C, Chen J, Wu L, et al. Phase 3 study of ivonescimab (AK112) vs. pembrolizumab as first-line treatment for PD-L1-positive advanced NSCLC: primary analysis of HARMONi-2. Presented at: 2024 World Conference on Lung Cancer; September 8, 2024; San Diego, CA. Accessed September 9, 2024. https://cattendee.abstractsonline.com/meeting/20598/Session/77
2. Summit Therapeutics. Ivonescimab monotherapy decisively beats pembrolizumab monotherapy head-to-head, achieves statistically significant superiority in PFS in first-line treatment of patients with PD-L1 positive NSCLC in China. Press release. May 30, 2024. Accessed September 9, 2024. www.smmttx.com/pressrelease/ivonescimab-monotherapy-decisively-beats-pembrolizumab-monotherapy-head-to-head-achieves-statistically-significant-superiority-in-pfs-in-first-line-treatment-of-patients-with-pd-l1-positive-nsclc-in/