Innovent Biologics Announces Phase 3 ORIENT-32 Trial of Sintilimab Plus Bevacizumab Biosimilar Meets Primary Endpoints in First-Line Treatment of Advanced Hepatocellular Carcinoma

On September 28, Innovent Bio announced that the Phase 3 clinical study (ORIENT-32) of Tyvyt (sintilimab injection) in combination with Byvasda (bevacizumab biosimilar) as first-line treatment for advanced hepatocellular carcinoma met the primary endpoints of progression-free survival (PFS) and overall survival (OS) in its interim analysis. This is the first Phase 3 study worldwide to report positive results for a programmed cell death protein 1 (PD-1) inhibitor-based combination therapy as first-line treatment for advanced hepatocellular carcinoma, having met its primary endpoints.

Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), Tyvyt (sintilimab injection) in combination with Byvasda (bevacizumab biosimilar) significantly prolonged progression-free survival (PFS) and overall survival (OS) compared to the active control group, meeting the prespecified superiority criteria. The safety profile was consistent with previously reported findings for Tyvyt (sintilimab injection) and Byvasda (bevacizumab biosimilar), with no new safety signals identified. The relevant study results will be presented at an upcoming academic conference. Following the IDMC’s recommendation, Innovent Bio plans to engage with the Center for Drug Evaluation of the National Medical Products Administration (NMPA) regarding the submission of a supplemental New Drug Application (sNDA) for the new indication of Tyvyt (sintilimab injection) in combination with Byvasda (bevacizumab biosimilar) as first-line treatment for advanced hepatocellular carcinoma.

Currently, liver cancer is the fourth most common malignant tumor and the second leading cause of cancer-related mortality in China. Approximately half of the new cases and deaths from liver cancer worldwide occur in China. About 85% of liver cancer patients in China have a background of hepatitis B virus (HBV) infection, which differs significantly from patterns observed in European and American countries. Therefore, conducting clinical research targeting Chinese liver cancer patients is of great significance. Currently, there are limited first-line treatment options approved for advanced liver cancer in China. The results of the ORIENT-32 study demonstrated that sintilimab combined with bevacizumab can extend overall survival (OS) and progression-free survival (PFS) as a first-line treatment for advanced liver cancer in China. Innovent Bio anticipates that the combination of Tyvyt (sintilimab injection) and Byvasda (bevacizumab biosimilar) will benefit more liver cancer patients.

About the ORIENT-32 Study

The ORIENT-32 study is a randomized, open-label, multicenter trial evaluating the efficacy and safety of Tyvyt (sintilimab injection) in combination with Byvasda (bevacizumab biosimilar) versus an active comparator as first-line treatment for advanced hepatocellular carcinoma (ClinicalTrials.gov, NCT03794440). The primary endpoints were overall survival (OS) and progression-free survival (PFS) assessed by an independent radiology review committee according to RECIST v1.1 criteria.

Subjects were randomized in a 2:1 ratio to receive either Tyvyt (sintilimab injection) in combination with Byvasda (bevacizumab biosimilar) or the positive control drug, until disease progression, intolerable toxicity, withdrawal of informed consent, death, or other criteria for treatment discontinuation specified in the protocol occurred, whichever came first.

About Tyvyt (Sintilimab Injection)

Tyvyt (sintilimab injection) is an innovative, internationally-quality biopharmaceutical co-developed by Innovent Bio and Eli Lilly in China. Its approved indication is for the treatment of relapsed or refractory classical Hodgkin lymphoma after at least two lines of systemic chemotherapy, and it was included in the 2019 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoma. During the national reimbursement drug list negotiations in November 2019, Tyvyt (sintilimab injection) was the only PD-1 inhibitor included in the National Reimbursement Drug List.

In April 2020, the NMPA formally accepted the sNDA for Tyvyt (sintilimab injection) in combination with Alimta (pemetrexed disodium for injection) and platinum-based chemotherapy as first-line treatment for non-squamous non-small cell lung cancer (NSCLC). In May 2020, the Phase 3 ORIENT-12 study of Tyvyt (sintilimab injection) in combination with Gemzar (gemcitabine for injection) and platinum-based chemotherapy as first-line treatment for locally advanced or metastatic squamous NSCLC met its primary endpoint. The ORIENT-2 study of Tyvyt (sintilimab injection) monotherapy as second-line treatment for advanced/metastatic esophageal squamous cell carcinoma also met its primary endpoint. In August 2020, the NMPA formally accepted the sNDA for Tyvyt (sintilimab injection) in combination with Gemzar (gemcitabine for injection) and platinum-based chemotherapy as first-line treatment for locally advanced or metastatic squamous NSCLC.

Tyvyt (sintilimab injection) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to the PD-1 molecule on the surface of T cells, thereby blocking the PD-1/PD-L1 pathway responsible for tumor immune tolerance and reactivating T cells to kill tumor cells. Currently, Innovent Bio is conducting more than 20 clinical studies (including over 10 registrational or pivotal trials) to evaluate the efficacy and safety of sintilimab across various oncology indications.

References:

[1] The Phase III ORIENT-32 Study of Tyvyt (Sintilimab Injection) Combined with Byvasda (Bevacizumab Biosimilar) as First-Line Treatment for Advanced Liver Cancer Met Its Primary Endpoint. Retrieved 2020-09-28, from http://www.cninfo.com.cn/new/disclosure/detail?stockCode=01801&announcementId=1208501912&orgId=9900037824&announcementTime=2020-09-28

Source: Jike Pharma News

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