Akeso's Cadonilimab (PD-1/CTLA-4), the First Dual Immune Checkpoint Inhibitor to Treat Cancer, Approved for Marketing in China

• Globally first dual immune checkpoint inhibitor bi-specific antibody approved for marketing
• China's first immunotherapy bi-specific antibody approved for marketing
• A phase III trial of Cadonilimab combined with platinum-based chemotherapy +/- bevacizumab for the first-line treatment of recurrent/metastatic cervical cancer has completed patients enrollment, a phase III trial of Cadonilimab plus concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC) is ongoing
• A phase III trial of Cadonilimab in early stage hepatocellular carcinoma (HCC), and a phase III trial in gastric (G) or gastroesophageal junction (GEJ) cancer are also ongoing

HONG KONG, June 29 2022 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso"), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology announced that its PD-1/CTLA-4 bi-specific antibody开坦尼® (Cadonilimab injection, AK104) has received marketing approval from the National Medical Products Administration (NMPA) of China, for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy.

开坦尼® is a novel, first-in-class PD-1/CTLA-4 bi-specific immuno-therapy drug in-house developed by Akeso. It is globally first dual immune checkpoint inhibitor bi-specific antibody approved for marketing . This approval not only marks China's innovative biotech companies starts to reap the fruits after years of R&D investments, but also demonstrates that Chinese biotech companies represented by Akeso are closing the gap with global pharmaceutical companies rapidly in innovative drug development.

The approval of 开坦尼® by NMPA is based on the positive results across a pivotal Phase II clinical study on Cadonilimab for treatment of R/M CC patients who progressed on or after platinum-based chemotherapy. The results were presented at 2022 Society of Gynecologic Oncology(SGO) Annual Meeting^[1].

• Among 100 evaluable patients with tumor assessment, the Objective Response Rate (ORR) confirmed by Independent Radiography Review Committee (IRRC) was 33.0%, the complete response (CR) rate was 12.0% and the Duration of Response (DoR) rates at 6 and 12 months were 77.6% and 52.9% respectively. The median Progression-free Survival (PFS) was 3.75 months. The median Overall Survival (OS) was 17.51 months.
• In the subgroup analysis, among the 64 patients with PD-L1 positive (CPS ≥ 1), ORR was 43.8%, median PFS was 6.34 months and median OS was not reached.
• Among the total 111 enrolled patients, the incidence rate of Grade≥3 treatment related adverse events(TRAEs) was 27.0%.

China has the second largest population of cervical cancer patients in the world, with 110,000 new cases in 2020.There is no standard treatment for R/M CC patients who has progressed on or after platinum-based chemotherapy, and monotherapy is a common clinical treatment option with limited efficacy and obvious toxicity. The approval of 开坦尼® addresses a huge unmet medical needs for advanced cervical cancer in China.

"Cadonilimab represents an important step forward for R/M CC treatment, and it's a more effective treatment option for all patients with advanced cervical cancer," said Professor Wu Xiaohua, Director of Oncology and Gynecology at the Cancer Hospital Affiliated to Fudan University. Findings from the study showed that Cadonilimab has superior anti-tumor effecacy in both PD-L1 positive and negative subjects with R/M CC who progressed on previous first-line platinum-based chemotherapy."

"Regarding approved therapies in China, the median OS of cervical cancer patients after second-line treatment is about 5 to 9 months. In contrast, Cadonilimab has extended the OS by about 8~13 months," said Professor Wu Xiaohua. "Cadonilimab is a safe, and efficient therapy that clinicians can choose with trust."

"We are thrilled to see the success of Cadonilimab in second-or third-line R/M CC," said Professor Wang Jing, Vice President of Hunan Cancer Hospital. "After its marketing approval, the gradual accumulation of medical evidence in the clinical application of Cadonilimab will not only help promote the ongoing Phase III clinical study on Cadonilimab plus platinum-based chemotherapy +/- bevacizumab in first-line treatment for R/M cervical cancer, but also further increase the confidence of clinicians and patients in selecting it when it's used in future first-line treatment."

"In the Phase II study on Cadonilimab for the first-line treatment of R/M CC in combination with platinum-based chemotherapy +/- Bevacizumab^[2], ORR was 79.3% regardless of PD-L1 expression; ORR was 82.4% for patients with CPS ≥ 1, and 75.0% for patients with CPS ＜ 1. Its safety profile is better than that shown in the disclosed data of clinical studies on other tumor immunotherapies combined with chemotherapy +/- Bevacizumab," said Professor Wang Jing. "This result continues Cadonilimab's excellent performance as monotherapy in second-or third-line R/M CC and heralds the significant clinical value of Cadonilimab with its great potential to cover the full spectrum of R/M CC population."

"I'm glad that 开坦尼® has been approved for marketing in China. As a first-in-class bi-specific antibody, 开坦尼® fully exploits the synergistic anti-tumor effect of two immune checkpoint inhibitors, PD-1 and CTLA-4, with significantly fewer side effects than the combined use of monoclonal antibodies with two targets," said Dr. Michelle Xia, Founder, Chairwoman and CEO of Akeso. "We believe its promising anti-tumor efficacy and safety profile will provide tangible clinical benefits to a wide range of oncology patients worldwide. We have established a professional and efficient commercialization team in China and will make this innovative drug available to patients as quickly as possible. Meanwhile we are accelerating its clinical research in lung cancer, liver cancer, gastric cancer, and other malignant tumors, while advancing the early-line treatments. We are confident to surpass existing therapy and promote tumor immunotherapy into the 2.0 era."

Currently, multiple clinical trials of Cadonilimab has been conducted in major cancer indications including lung, liver, stomach, cervical, renal cancer, and others. Among them, a global phase III trial of Cadonilimab combined with platinum-based chemotherapy +/- bevacizumab for the first-line treatment of recurrent/metastatic cervical cancer has completed patients enrollment, and a phase III trial of Cadonilimab plus concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC) is ongoing. In addition, two phase III trials of Cadonilimab to treat early-stage hepatocellular carcinoma (HCC) and gastric (G) or gastroesophageal junction (GEJ) cancer are also ongoing.

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