On April 13, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI310 in combination with sintilimab for the treatment of patients with recurrent or metastatic cervical cancer (Press release, Innovent Biologics, APR 13, 2022, View Source [SID1234612178]).
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The NMPA BTD for IBI310 was based on results from First part of a Phase 2 trial (CDE Registration No. CTR20202017). This study enrolled 205 patients in patients with advanced cervical cancer. The safety profile in this study was consistent with that observed in previously reported studies, and no additional safety signals were identified for the combination of IBI310 and sintilimab. Relevant study results will be published at an upcoming medical conference in 2022.
"We are glad to see the NMPA grant Breakthrough Therapy Designation based on the results of First part of Phase 2 data of IBI310," said Dr. Hui Zhou, Senior Vice President of Innovent. "Patients with advanced cervical cancer currently have limited treatment options. Patients treated with chemotherapy show limited clinical benefit and the overall survival is limited to a few months. The results of First part of the Phase 2 study of IBI310 in combination with sintilimab show potential for this combination as a new treatment option for patients in need. We look forward to obtaining more data from the ongoing pivotal Phase 2 trial which may support a future regulatory application in China for IBI310 in combination with sintilimab in recurrent or metastatic cervical cancer."
NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of an investigational drug to treat a serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but it will also allow the sponsor to obtain timely advice and communication from the CDE to accelerate the approval and launch to address the unmet clinical need of patients at an accelerated pace. Click here for the published list of drugs which have been granted BTD by NMPA.
About Cervical Cancer
According to GLOBOCAN 2020 report，there were approximately 110,000 new cases and 60,000 death cases of cervical cancer in China in 2020, making cervical cancer one of the most common malignant tumor types in gynecology. There is an urgent clinical need for more treatment options, especially for recurrent or metastatic cervical cancer, as traditional treatments such as surgery, chemotherapy and radiotherapy are ineffective with a low overall survival rate for those patients with recurrent or metastatic cervical cancer.
About IBI310
IBI310 is a recombinant fully-human IgG1 monoclonal antibody against cytotoxic T lymphocytic associated antigen 4 (CTLA-4) developed independently by Innovent Biologics. IBI310 can bind to CTLA-4 molecules and block the inhibition of T cells induced by CTLA-4, thereby leading to T cell activation and proliferation, and enhancing the anti-tumor activity of immune system to achieve the goal of tumor treatment.
About Sintilimab
Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody developed by Eli Lilly and Company and Innovent. Sintilimab 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 of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.
In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for four indications, including:
The treatment of relapsed or refractory classic Hodgkins lymphoma after two lines or later of systemic chemotherapy;
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of non-squamous non-small cell lung cancer lacking EGFR or ALK driver mutations;
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer;
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of unresectable or advanced hepatocellular carcinoma.
Additionally, Innovent currently has three regulatory submissions under review in China’s NMPA for sintilimab:
In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma;
In combination with chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
In combination with bevacizumab biosimilar and chemotherapy for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment.
Additionally, two clinical studies of sintilimab have met their primary endpoints:
Phase 2 study as second-line treatment of esophageal squamous cell carcinoma;
Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.