On May 31, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported the Phase 1b preliminary clinical study (NCT04072679) data of TYVYT (sintilimab injection) in combination with IBI305, a bevacizumab biosimilar independently developed by Innovent, in the treatment of advanced hepatocellular carcinoma at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)(Abstract # 3079, Poster # 143, 8:00 AM – 11:00 AM, U.S. Central Time, Friday, May 29, 2020) (Press release, Innovent Biologics, MAY 31, 2020, View Source [SID1234558751]).

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The NCT04072679 study, presented at the ASCO (Free ASCO Whitepaper) annual meeting by poster, was conducted by Professor Aiping Zhou from the Cancer Hospital Chinese Academy of Medical Sciences, and is a Phase 1b study assessing the safety, tolerability and anti-tumor activity of TYVYT in combination with IBI305 in subjects with advanced hepatocellular carcinoma, the most common form of liver cancer. The study was divided into two parts, the first is a dose escalation phase and the second is a dose expansion phase. In the dose escalation phase, according to the enrollment sequence, subjects will receive either 7.5 mg/kg (low-dose group) or 15 mg/kg (high-dose group) of IBI305 in combination with a fixed dose of 200 mg of sintilimab, respectively, and then entered into the dose expansion phase after completing the dose escalation phase. The main clinical data include:

As of January 7, 2020, a total of 50 subjects were enrolled, including 29 subjects in the low-dose group and 21 subjects in the high-dose group. 29 subjects in the low-dose group had at least two efficacy evaluations, of which 7 subjects had confirmed a partial response (PR), with objective response rate (ORR) of 24.1%; 18 subjects in the high-dose group had at least one efficacy evaluation, 6 subjects had a PR (1 unconfirmed, 5 confirmed), with an ORR of 33.3%.
Treatment-related adverse events (TRAEs) were mostly Grade 1-2, with the most common TRAEs including hypertension (28%) and pyrexia (26%); a total of 6 (12%) subjects experienced Grade ≥ 3 TRAEs, with the most common Grade ≥ 3 TRAE being hypertension (2 subjects).
Professor Zhou Aiping from Cancer Hospital Chinese Academy of Medical Sciences said："Hepatocellular carcinoma is a common malignant tumor in China. Most patients with hepatocellular carcinoma have entered into the advanced stage at time of diagnosis and are beyond the point where surgery could effectively remove all of the cancer. There is a long-term lack of effective treatment for advanced hepatocellular carcinoma. In recent years, with the rise of immunotherapy, immunotherapy combined with anti-vascular targeted therapy has attracted more and more clinicians’ attention, and multiple studies have shown outstanding clinical effects. This Phase 1b study preliminarily showed positive efficacy and good safety in patients with advanced liver cancer. Currently, there is a Phase 3 clinical trial of sintilimab in combination with IBI305 for first-line treatment of patients with advanced liver cancer ongoing, and we are hopeful to see positive results from this study to help more patients with liver cancer."

Dr. Zhou Hui, Vice President of Medical Science and Strategic Oncology of Innovent, said: "The combination of immunotherapy and anti-angiogenic therapy has a synergistic effect in the mechanism of action and is currently a hot spot for the clinical development of anti-tumor drugs. We are very pleased to see that sintilimab in combination with the bevacizumab biosimilar IBI305 has achieved preliminary positive efficacy in patients with advanced hepatocellular carcinoma and been showing the clinical application prospect of the combination of these two drugs in the treatment of liver cancer. We also hope that through our efforts, we can bring a new effective treatment option to patients in China with this type of cancer."

About TYVYT (sintilimab injection)

TYVYT (sintilimab injection), an innovative drug developed with global quality standards jointly developed by Innovent and Lilly in China, has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT (sintilimab injection) is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019.

TYVYT (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.

About IBI305 (bevacizumab biosimilar)

IBI305 is a biosimilar of bevacizumab injection, which is a recombinant human anti-vascular endothelial growth factor (VEGF) monoclonal antibody injection, independently developed by Innovent. VEGF is an important factor in the angiogenic process and is overexpressed pathologically in the endothelial cells of most human tumors. Anti-VEGF antibody can selectively bind VEGF with high affinity, block the conduction of PI3K-Akt/PKB and Ras-Raf-MEK-ERK signaling pathways by blocking the binding of VEGF to receptors on the surface of vascular endothelial cells, thereby inhibiting the growth, proliferation and migration of vascular endothelial cells as well as angiogenesis, reducing vascular permeability, blocking the blood supply of tumor tissues, inhibiting the proliferation and metastasis of tumor cells, and inducing tumor cell apoptosis, so as to achieve anti-tumor therapeutic effect. On January 29, 2019, the NMPA accepted the New Drug Application (NDA) for IBI305 and was included in the priority review.