Ivonescimab Plus Chemo May Slow Advanced NSCLC Progression

Among patients with advanced squamous non–small cell lung cancer (NSCLC), treatment with the PD-1/VEGF bispecific antibody ivonescimab in combination with chemotherapy was associated with positive progression-free survival results, according to study findings.

First-line treatment with the ivonescimab plus chemotherapy combination was evaluated in the phase 3 AK112-306/HARMONi-6 trial for patients with advanced squamous NSCLC. According to results the first pre-specified interim analysis of the study, the combination elicited both statistically significant and clinically meaningful results, according to a news release issued by Akeso, Inc.

Detailed results from the study, according to the news release, will be presented at a medical meeting later this year.

"It is a great honor for us to witness ivonescimab once again successfully challenge the optimal standard of care,” said Professor Lu Shun, of Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, and principal investigator of the AK112-306/HARMONi-6 study. “This breakthrough not only advances the treatment of NSCLC cancer but also marks a significant milestone in global oncology immunotherapy."

According to the news release, the HARMONi-6 study showed that among patients in the intention-to-treat population, the combination of ivonescimab and chemotherapy exhibited clinically meaningful progression-free survival benefits among both PD-L1-positive and PD-L1-negatative patient populations.

"The interim analysis results from the HARMONi-6 study show that ivonescimab in combination with chemotherapy significantly prolonged progression-free survival compared to [Tevimbra (tislelizumab)] with chemotherapy,” Shun added. “In patients with up to 63% central squamous carcinoma, ivonescimab demonstrated a safety profile comparable to the control group. This highlights its potential to overcome the limitations of bevacizumab in treating squamous NSCLC, ultimately enhancing the clinical benefits of immunotherapy for NSCLC. With its combined immune and antiangiogenic mechanisms, ivonescimab offers a promising new treatment option for patients with advanced squamous carcinoma.”

The trial, the company stated, was conducted at 66 clinical research centers in China and has enrolled 532 patients, among whom ivonescimab displayed a favorable safety profile with no new safety signals. HARMONi-6, the news release noted, is the third phase 3 clinical trial of ivonescimab to show results in lung cancer, and the treatment’s second phase 3 clinical trial with results among patients with lung cancer in a head-to-head comparison versus PD-1 inhibitors.

"Today, we are incredibly excited to announce the third significant positive result for ivonescimab in a phase 3 study,” said Dr. Xia Yu, founder, chairwoman, president and CEO of Akeso, in the news release. “PD-1 combined with chemotherapy remains the global standard of care for first-line treatment of NSCLC. Ivonescimab has once again demonstrated its breakthrough clinical value and market competitiveness as a next-generation cancer therapy through compelling clinical data. We sincerely thank all the investigators, participants, and patients who have contributed to this clinical study."

"Beyond its demonstrated superior efficacy and safety in NSCLC, ivonescimab is currently being tested in multiple phase 2 and 3 trials across other cancer types, establishing a clear leadership in both improving patients’ lives and addressing critical unmet need across multiple cancer types,” Yu concluded. “The success of the HARMONi-6 study validates our very high confidence in continuing to integrate global resources and advancing ivonescimab's role as a next-gen immunotherapy. We look forward to working with our partner Summit on expanding global access to ivonescimab. We are impressed by and also appreciative of their progress in developing ivonescimab in the U.S., Europe and Japan. We are committed to improving the standard of care, changing treatment approaches, and offering safer, more unwaveringly effective solutions for patients worldwide."

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