Akeso Completes Patient Enrollment for Phase III Trial of Ivonescimab vs. Tislelizumab in Sq-NSCLC

HONG KONG, Feb. 5, 2025 — Akeso, Inc. (9926.HK), referred to as "Akeso" or "the Company," has successfully finalized patient enrollment for its global Phase III clinical trial, known as HARMONi-6/AK112-306. This pivotal study is investigating ivonescimab, a bispecific antibody targeting PD-1 and VEGF. Conducted in China, the trial assesses the efficacy of ivonescimab combined with platinum-based chemotherapy against tislelizumab, another PD-1 inhibitor, paired with platinum-based chemotherapy, as the initial treatment option for squamous non-small cell lung cancer (sq-NSCLC).

Akeso is conducting several additional international Phase III clinical trials for ivonescimab. Among these is the HARMONi-3 trial, which compares ivonescimab with chemotherapy to pembrolizumab with chemotherapy for the first-line treatment of both squamous and non-squamous NSCLC. Summit Therapeutics, Akeso’s global partner for ivonescimab, is spearheading this efficient trial.

The HARMONi-6/AK112-306 trial represents just one of six registrational Phase III studies globally focused on ivonescimab for lung cancer. In all these trials, PD-1/L1 inhibitors serve as comparators, marking a significant advancement in cancer immunotherapy. This series of studies aims to establish superior treatment standards worldwide and to explore the full clinical and commercial potential of ivonescimab within Akeso's portfolio.

In China, ivonescimab, used with chemotherapy, is already approved for treating non-squamous NSCLC that is resistant to EGFR-TKI. A Supplemental New Drug Application (sNDA) is under review for ivonescimab monotherapy as a first-line option for PD-L1-positive NSCLC, compared to pembrolizumab. This application has been prioritized in China, underscoring its potential significance.

Ivonescimab represents a next-generation, highly effective cancer immunotherapy, and its application extends beyond lung cancer. The drug is currently undergoing multiple Phase III studies for various types of cancers. These include trials for PD-L1-positive head and neck squamous carcinoma (compared to pembrolizumab), first-line biliary tract cancer treatment (with chemotherapy versus durvalumab plus chemotherapy), and first-line pancreatic cancer treatment. Additionally, clinical trials are in progress for treating triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, ovarian cancer, and gastric cancer with ivonescimab.

As these trials advance, ivonescimab may redefine immuno-oncology standards globally, realizing its clinical and commercial potential on an international scale. Statistics reveal an annual occurrence of over 520,000 cases of advanced sq-NSCLC lacking driver genes, with many patients unsuitable for anti-angiogenesis treatments like bevacizumab. While combining PD-1/L1 inhibitors with chemotherapy is the global norm, including in the U.S. and China, patient outcomes remain suboptimal, underscoring an urgent unmet need.

Phase III trials suggest that ivonescimab, targeting PD-1 and VEGF, provides a synergistic anti-tumor effect with a favorable safety profile. This positions ivonescimab as a promising alternative for sq-NSCLC patients who cannot receive bevacizumab due to bleeding risks. Ivonescimab is set to revolutionize first-line treatment for locally advanced or metastatic sq-NSCLC, offering a safer and more effective immunotherapy option that surpasses current treatment standards.