HARMONi-6 Meets Primary End Point of Progression-Free Survival in Squamous NSCLC

The phase 3 HARMONi-6 trial has met its primary end point of progression-free survival (PFS) at the first prespecified interim analysis by an independent data monitoring committee, according to an announcement from Akeso, Inc.

Ivonescimab plus chemotherapy has “demonstrated strongly positive results” in the trial as a first-line treatment for advanced squamous non–small cell lung cancer (NSCLC), and the results of the trial are “both statistically significant and clinically meaningful,” officials said in the announcement.

“Today, we are incredibly excited to announce the third significant positive result for ivonescimab in a Phase III study,” Dr. Xia Yu, founder, chairwoman, president, and CEO of Akeso, said in a statement. “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.”

The HARMONi-6 trial enrolled 532 patients, with around 63% of patients having centrally located squamous cell carcinoma, which is “consistent with real-world patient populations,” officials said. The data from the study’s intention-to-treat population showed that ivonescimab plus chemotherapy “decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS),” showing “clinically meaningful PFS benefits in both PD-L1-positive and PD-L1-negative populations,” according to the announcement.

Ivonescimab also “demonstrated a favorable safety profile, with no new safety signals identified,” officials said. “The incidence of treatment related serious adverse events and the incidence of bleeding events of grade 3 or higher were comparable to those of the control group,” according to the announcement.

Detailed results from the HARMONi-6 study will be presented at an upcoming medical conference later this year, officials said. Lu Shun, MD, PhD, the principal investigator of the HARMONi-6 study, weighed in on the findings in a statement provided by Akeso.

“It is a great honor for us to witness ivonescimab once again successfully challenge the optimal standard of care. This breakthrough not only advances the treatment of non-small cell lung cancer but also marks a significant milestone in global oncology immunotherapy,” said Dr. Shun, who serves as director of Shanghai Lung Cancer, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine.

The HARMONi-6 study, which was conducted at 66 clinical research centers across China, represents the third phase 3 clinical trial with ivonescimab showing “positive results in lung cancer, highlighting that treatment with ivonescimab can overcome the limitations of bevacizumab in treating squamous-NSCLC,” officials said in the announcement.

In addition, the trial also represents the second phase 3 trial of the treatment to show “positive results in lung cancer in head-to-head comparisons vs. PD-1 inhibitors, further establishing ivonescimab as a comprehensive treatment option for both first-line and later-line NSCLC,” the announcement states.

Dr. Yu also explained the implications of HARMONi-6 and future directions with ivonescimab in a statement.

“Beyond its demonstrated superior efficacy and safety in non-small cell lung cancer, ivonescimab is currently being tested in multiple Phase II and III trials across other cancer types, establishing a clear leadership in both improving patients’ lives and addressing critical unmet need across multiple cancer types,” Dr. Yu said. “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 US, 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.”

Dr. Shun shared insights on how the HARMONi-6 trial data fit into the larger treatment and data landscape for NSCLC.

“The HARMONi-2 study showed strong positive results for PD-L1-positive squamous and non-squamous NSCLC in first-line treatment,” Dr. Shun said in a statement. “Additionally, the recent HARMONi-6 study demonstrated significant positive outcomes in first-line squamous NSCLC, further confirming ivonescimab’s exceptional efficacy in both squamous and non-squamous cancers.”

Source:

Akeso. Accessed April 23, 2023. https://www.akesobio.com/en/media/akeso-news/250423/