On August 29, 2023 Akeso Inc. ("Akeso", 9926. HK) reported completion of patient enrollment in a head-to-head study of ivonescimab (AK112, PD-1/VEGF bispecific antibody) compared with pembrolizumab as first-line treatment for patients with PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Akeso Biopharma, AUG 29, 2023, View Source [SID1234634763]).

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The patient enrollment completion represents another milestone in ivonescimab’s major indications development after the recent New Drug Application (NDA) acceptance from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).

Ivonescimab was already granted Breakthrough Therapy Designation (BTD) by CDE as first-line treatment for NSCLC patients with positive PD-L1 expression, which will expedite the new drug launch and commercialization of ivonescimab.

In 2020, the worldwide number of newly diagnosed lung cancer patients surpassed 2.2 million, with over 810,000 new cases in China. NSCLC patients account for approximately 85% of all lung cancer cases, and approximately 70% are diagnosed at advanced stages of the disease. Pembrolizumab monotherapy, as a first-line standard therapy for the treatment of PD-L1-positive advanced NSCLC, has been approved by the U.S. Food and Drug Administration (FDA) and recommended by the National Comprehensive Cancer Network (NCCN) Guidelines and the Chinese Society of Clinical Oncology (CSCO) Guidelines. Pembrolizumab is also an immunotherapy to treat various cancers which is widely recognized by the global medical community, with its global sales revenue exceeding $20.9 billion in 2022.

The ongoing Phase III head-to-head clinical trial of ivonescimab for NSCLC in comparison with standard-of-care PD- (L)1 inhibitors conducted in China, the United States, Europe, and other developed countries has demonstrated Akeso’s determination and confidence in pursuing the evidence-based medical evidence for the use of ivonescimab in NSCLC on the basis of clinical value, which will help to accelerate the success of ivonescimab in product launch and commercialization in the global market.

Following an acceptance of the marketing application of ivonescimab by the China CDE, four pivotal registrational Phase III clinical trials have been initiated/are being conducted worldwide, including three head-to-head trials with PD-1 monoclonal antibody as the positive control drug:

A Phase III study of ivonescimab monotherapy versus pembrolizumab monotherapy as first-line treatment for NSCLC patients with positive PD-L1 expression (AK112-303), which has been granted BTD in China.
An international multicenter Phase III study of Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy (HARMONi/AK112-301), which has been granted BTD in China.
A Phase III study in China for the first-line treatment of advanced squamous NSCLC with ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy（AK112-306).
An international multicenter Phase III study of ivonescimab in combination with chemotherapy versus pembrolizumab monoclonal antibody in combination with chemotherapy as the first-line treatment for metastatic squamous NSCLC (HARMONi-3).
About Ivonescimab

Ivonescimab is a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso and is believed to be the PD-1 / VEGF bispecific antibody that is most advanced in the clinic. It combines the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab is currently engaged in multiple Phase III clinical trials worldwide.

In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics("Summit"). Akeso out-licensed to Summit exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the world including China. Ivonescimab is known as AK112 for Akeso’ R&D code at China and Australia, and as SMT112 for Summit’s license territories.