Innovent Bio announced that its anti-CTLA-4 monoclonal antibody IBI310 has been included in the breakthrough therapy category by the State Drug Administration for the treatment of cervical cancer in combination with sintilimab

Innovent Biopharmaceutical Group (Hong Kong Stock Exchange: 01801), a biopharmaceutical company dedicated to the research and development, production and sales of innovative drugs for the treatment of tumors, metabolic diseases, autoimmunity and other major diseases, announced that IBI310 (recombinant Fully human anti-CTLA-4 monoclonal antibody) has been included in the Breakthrough Therapy Drug List (BTD) by the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE), and the proposed indication is combined with sintilimab for use in Treatment of patients with recurrent or metastatic advanced cervical cancer
.
The breakthrough therapy designation of IBI310 is based on the results of an ongoing Phase 2 clinical study in patients with advanced cervical cancer (CDE registration number: CTR20202017) Phase 1 data
.
A total of 205 patients with advanced cervical cancer who failed or could not tolerate first-line platinum-containing chemotherapy were enrolled in this study, and were randomized to receive IBI310 combined with sintilimab therapy or sintilimab monotherapy
.
According to the BTD application materials, IBI310 combined with sintilimab showed encouraging efficacy and better tolerability in patients with advanced cervical cancer
.
The safety profile in this study is consistent with the results of previously reported clinical studies related to IBI310 and sintilimab, and there are no new safety signals
.
Updated research results will be presented at a follow-up 2022 academic meeting
.
Dr.
Hui Zhou, Senior Vice President of Innovent Bio, said: "We are delighted that the preliminary trial data of IBI310 combined with sintilimab in patients with advanced cervical cancer has passed the review of the National Medical Products Administration's breakthrough treatment drug category
.
Advanced cervical cancer The existing treatment methods for patients are very limited, chemotherapy and other treatments are ineffective, the overall survival rate of patients is only a few months, and new treatment methods are urgently needed in clinical practice.

IBI310 combined with sintilimab is expected to become a new drug that these patients are eagerly looking forward to.
Treatment options
.
We very much look forward to additional data from the current pivotal Phase 2 trial to support the regulatory filing of IBI310 in combination with sintilimab
.
"Breakthrough therapy designation is designed to expedite the development of new medicines for serious diseases that have shown in preliminary clinical trials significantly better efficacy or safety than existing treatments
.
Obtaining breakthrough therapy designation enables the In the process of drug research and development, we have closely communicated with CDE and obtained guidance, so as to speed up the launch of new drugs and solve the unmet clinical needs of Chinese patients earlier
.
Click here to view the list of varieties that have been included in breakthrough therapy
.
About cervical cancer according to the World Health Organization International According to the latest global cancer burden data (GLOBCAN 2020) released by the Cancer Research Institute (IARC), there will be 110,000 new cervical cancer cases and 60,000 deaths in Chinese women in 2020.

Persistent, recurrent or metastatic cervical cancer has always been The difficulty in the treatment of cervical cancer, the conventional treatment methods such as surgery, radiotherapy and chemotherapy are also poor in the treatment of this type of cervical cancer, and the overall survival rate of patients is low
.
Cervical cancer, as a common malignant tumor in gynecology, seriously threatens the life and health of women, and More clinical options are urgently needed
.
About IBI310 (CTLA-4) Recombinant fully human anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody injection (R&D code: IBI310) is a product of Innovent Biopharmaceuticals A fully human monoclonal antibody independently developed by (Suzhou) Co.
, Ltd.

IBI310 can specifically bind to CTLA-4, thereby blocking CTLA-4-mediated T cell inhibition, promoting T cell activation and proliferation, and improving tumor immunity Reaction to achieve anti-tumor effect
.
About Sintilimab Sintilimab, the Chinese brand name is Daboshu? (sintilimab injection), is a joint research and development of Innovent Biopharmaceuticals and Eli Lilly.
innovative PD-1 inhibitor drugs
.
Sintilimab is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to the PD-1 molecule on the surface of T cells, thereby blocking PD-1/programmed death receptors that lead to tumor immune tolerance.
The Programmed Death-Ligand 1 (PD-L1) pathway reactivates the anti-tumor activity of lymphocytes, thereby achieving the goal of treating tumors
.
More than two dozen clinical studies (of which more than 10 are registration clinical trials) are currently underway to evaluate the antitumor effect of sintilimab on various solid tumors and hematological tumors
.
Sintilimab has been approved in China for four indications and has been successfully included in China’s National Reimbursement Catalog, including: For the treatment of relapsed or refractory classical Hodgkin lymphoma that has undergone at least second-line systemic chemotherapy; Combination Pemetrexed and platinum-based chemotherapy for first-line treatment of EGFR- or ALK-negative advanced non-squamous NSCLC; Combination with gemcitabine and platinum-based chemotherapy for first-line treatment of unresectable locally advanced or metastatic squamous NSCLC; Combined with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy
.
In addition, the marketing application of sintilimab has been accepted and reviewed by the China National Medical Products Administration (NMPA) for three indications, including: Combination of cisplatin and paclitaxel/cisplatin and 5-fluorouracil for advanced or metastatic esophagus First-line treatment of squamous cell carcinoma; Combined with oxaliplatin and capecitabine for first-line treatment of unresectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma; Combined with bevacizumab and chemotherapy for Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) treatment failure in EGFR-mutant non-squamous non-small cell lung cancer
.
Two other clinical trials of sintilimab reached their endpoints, including: Phase II clinical study of single agent for second-line treatment of advanced/metastatic esophageal squamous cell carcinoma; Single agent for advanced squamous cell carcinoma that failed platinum-based chemotherapy Phase III clinical study of second-line treatment of non-small cell lung cancer
.