{"id":33703,"date":"2025-02-06T01:28:00","date_gmt":"2025-02-06T01:28:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4613214_CN13214_0"},"modified":"2025-02-06T01:28:00","modified_gmt":"2025-02-06T01:28:00","slug":"akeso-announces-the-completion-of-patient-enrollment-in-the-phase-iii-clinical-trial-harmoni-6-comparing-ivonescimab-and-tislelizumab-for-first-line-treatment-of-sq-nsclc","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=33703","title":{"rendered":"Akeso Announces the Completion of Patient Enrollment in the Phase III Clinical Trial (HARMONi-6) Comparing Ivonescimab and Tislelizumab for First-Line Treatment of Sq-NSCLC"},"content":{"rendered":"
\n

HONG KONG<\/span>, Feb. 6, 2025 \/PRNewswire\/ — Akeso, Inc. (9926.HK) (“Akeso” or the “Company”) <\/b>  is excited to announce the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6\/AK112-306) evaluating ivonescimab, its independently developed PD-1\/VEGF bispecific antibody. This clinical study, conducted in China<\/span>, compares ivonescimab in combination with platinum-based chemotherapy to tislelizumab (a PD-1 inhibitor) combined with platinum-based chemotherapy as a first-line treatment for squamous non-small cell lung cancer (sq-NSCLC).<\/span><\/p>\n

In addition, several international Phase III clinical trials of ivonescimab are underway.  These clinical studies include the HARMONi-3 clinical trial, which compares ivonescimab plus chemotherapy to pembrolizumab plus chemotherapy for the first-line treatment of both sq-NSCLC and non-squamous NSCLC (nsq-NSCLC). This trial is being efficiently led by Summit Therapeutics, Akeso’s global partner for ivonescimab.<\/p>\n

The HARMONi-6\/AK112-306 trial is one of six registrational\/Phase III studies worldwide for ivonescimab for lung cancer. It is also one of six studies where PD-1\/L1 inhibitors are used as comparators. This initiative is a critical step in advancing cancer immunotherapy, establishing superior global treatment standards, and exploring the full clinical and commercial potential of ivonescimab within Akeso’s portfolio.<\/p>\n

Ivonescimab, in combination with chemotherapy, has already been approved in China<\/span> for the treatment of EGFR-TKI-resistant, non-squamous NSCLC. The New Drug Application (sNDA) for ivonescimab monotherapy as a first-line treatment for PD-L1-positive NSCLC (in comparison to pembrolizumab) is currently under review and has been granted priority status in China<\/span>.<\/p>\n

As a next-generation, highly efficacious cancer immunotherapy, ivonescimab is also in multiple Phase III studies beyond lung cancer.  These studies include ongoing Phase III trials for PD-L1-positive head and neck squamous carcinoma (vs. pembrolizumab), first-line treatment of biliary tract cancer (with chemotherapy vs. durvalumab + chemotherapy), and the first-line treatment of pancreatic cancer. Clinical trials of ivonescimab for the first-line treatment of triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, ovarian cancer and gastric cancer, are also in progress.<\/p>\n

As these studies progress, ivonescimab has the potential to redefine the standard of care in immuno-oncology around the world, with its clinical and commercial potential realized on a global scale.<\/p>\n

Data indicates that the annual incidence of advanced, driver gene-negative sq-NSCLC exceeds 520,000 cases, with many patients ineligible for anti-angiogenesis treatments like bevacizumab. While PD-1\/L1 inhibitors combined with chemotherapy have become the global standard of care, including in the U.S. and China<\/span>, the prognosis for these patients remains poor, highlighting a critical unmet need. Phase III studies show that ivonescimab, targeting both PD-1 and VEGF, offers a synergistic anti-tumor effect with a favorable safety profile. This makes ivonescimab a promising alternative for sq-NSCLC patients who cannot receive bevacizumab due to bleeding risks. Ivonescimab is poised to transform first-line treatment for locally advanced or metastatic sq-NSCLC, providing a safer and more effective immunotherapy option that exceeds current treatment standards.<\/p>\n<\/p><\/div>\n

Source: Akeso, Inc.<\/p>\n","protected":false},"excerpt":{"rendered":"

HONG KONG, Feb. 6, 2025 \/PRNewswire\/ — Akeso, Inc. (9926.HK) (“Akeso” or the “Company”)  is excited to announce the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6\/AK112-306) evaluating ivonescimab, its independently developed PD-1\/VEGF bispecific antibody. 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