- Oral presentation on the results of sintilimab for relapsed/refractory extranodal NK/T cell lymphoma

SUZHOU, China, May 16, 2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, today announced that the research data on the treatment of relapsed or refractory extranodal NK/T cell lymphoma (ORIENT-4) with sintilimab, co-developed with Eli Lilly and Company ("Lilly") and key data from six other clinical studies will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) by oral presentation and posters.

The results of ORIENT-4 will be presented during an oral session at the 55th Annual Meeting of the ASCO in Chicago on June 4, 2019 [Abstract #7504; Tuesday, June 4, 10:57 AM -11:09 AM CDT].

ORIENT-4, the multicenter, single-arm, Phase 2 clinical trial for relapsed/refractory (r/r) extranodal NK/T cell lymphoma (ENKTL) in China, evaluates the efficacy and safety of sintilimab as monotherapy in the treatment in patient with r/r ENKTL. This trial includes 28 patients with r/r ENKTL who had treatment progression despite receiving an average of 3 conventional treatments. The primary end point of the trial is the objective response rate (ORR). According to pre-defined response criteria 19 patients achieved objective response resulting in a 68% ORR and 85.7% disease control rate (DCR). (The data was cut-off on February 2, 2019, when 19 patients were still on treatment.)

"ENKTL is a rare tumor with a proclivity for East Asians. Recurrent or refractory patients who are not cured by standard of care therapy are in urgent need for new drugs with better efficacy and safety. EB virus infection is common in ENKTL and often results in immuno-hot tumor phenotype. The ORR of sintilimab in this trial of r/r ENKTL patients is 68% and most patients have enjoyed disease control. We are looking forward to studying sintilimab in other hematological tumors," said Professor Jianyong Li from Department of Haematology, Jiangsu Province Hospital.

"We are announcing key findings from several clinical studies at ASCO that demonstrate the significant progress we have made in the field of tumor immunotherapy. In particular, the results of the ORIENT-4 study give us hope that sintilimab has the requisite efficacy, tolerance and safety to become an important player in the treatment of r/r ENKTL. It could provide a new treatment option to patients," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent. "Innovent strives 'to develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people.' We hope our efforts contribute new cancer therapeutics by progressing clinical oncology research in China. "

During the same conference, Innovent will also publish key findings from the six other clinical studies in posters and other sessions at the ASCO 2019 Annual Meeting including:

• Efficacy and Safety of Sintilimab in Combination with CAPOX in First-line Gastric or Gastroesophageal Junction Carcinoma (GC/GEJC) in Phase 1b Study [Abstract #4042; Monday, June 3, 8:00 AM -11:00 AM CDT]. Sintilimab is shown to have favorable efficacy and safety profiles. A randomized, Phase 3 study of sintilimab in combination with CAPOX in first line gastric cancer is ongoing (NCT03745170).
• Efficacy and Safety of Neoadjuvant PD-1 Blockade with Sintilimab in Resectable Squamous Non-Small Cell Lung Cancer (sqNSCLC) [Abstract #8531; Sunday, June 2, 8:00 AM -11:00 AM CDT]. The trial shows that neoadjuvant sintilimab for sqNSCLC patients is tolerable and the major pathologic response (MPR) rate is encouraging.
• Sintilimab for relapsed/refractory classical Hodgkin's lymphoma: Extended follow-up on the multicenter, single-arm Phase II ORIENT-1 study [Abstract #7533; Monday, June 3, 8:00 AM -11:00 AM CDT]. The trial is the largest clinical trial of classical Hodgkin's lymphoma patients treated with PD-1 in China. In addition to high objective response and complete response rates, sintilimab also shows sustained efficacy and acceptable long-term safety during follow-up.
• Efficacy and safety of IBI305 compared with bevacizumab in advanced non-squamous NSCLC patients as first-line treatment in a randomized, double-blind, phase 3 study [Abstract #9095; Sunday, June 2, 8:00 AM -11:00 AM CDT]. The trial demonstrates the therapeutic similarities between IBI305 (the biosimilar drug candidate of bevacizumab) and bevacizumab. The controlled trial has achieved the predefined primary end points and meets the prespecified clinical similarity measures for ORR. There are no significant difference in safety profile and immunogenicity between the two experimental arms.
• Circulating Tumor DNA Predicts Response and Resistance by anti-PD-1 Therapy in Chinese Relapsed/Refractory Classic Hodgkin Lymphoma [Abstract #7534; Monday, June 3, 8:00 AM -11:00 AM CDT]. The study demonstrated that ctDNA could serve as valuable biomarker for prediction of response or resistance to anti-PD1 immunotherapy.
• Phase Ib Study of Sintilimab in Combination with Chemotherapy for 1L Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC). The combination of sintilimab and chemotherapy shows an acceptable efficacy and safety profile in 1L nsq- and sq-NSCLC (Reference # e20546). Two Phase 3 trials are ongoing to evaluate the combination in 1L nsq- (NCT03607539) and sq-NSCLC (NCT03629925) respectively.

About ORIENT-4

ORIENT-4 is a multicenter, single-arm, Phase 2 trial which evaluates the efficacy and safety of sintilimab monotherapy in subjects with relapse/refractory extranodal NK/T cell lymphoma (nasal type) in China. Patients will receive 200 mg sintilimab every 3 weeks until disease progression. The study enrolled 28 patients. The primary endpoint is objective response rate per LUGANO2014 criteria.

About Relapsed/Refractory (r/r) Extranodal NK/T Cell Lymphoma (ENKTL)

Extranodal NK/T cell lymphoma is an aggressive malignancy and accounts for more than 20% of the peripheral T-cell lymphoma in Asia. Patients with relapse or refractory disease have few treatment options and poor prognosis. According to historical data, the overall survival is about 6 months, reflecting huge unmet medical needs.

About Tyvyt^® (sintilimab injection)

Tyvyt^® (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. 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-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt^® (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt^® (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection, including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.

About IBI305 (bevacizumab biosimilar)

IBI305 is a biosimilar product candidate of bevacizumab and a recombinant humanized anti-VEGF monoclonal antibody for injection. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. Bevacizumab produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. The new drug application (NDA) of IBI305 was accepted by the NMPA on January 29, 2019 and has been granted with priority review status.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmunity and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built up a robust pipeline of 20 innovative assets in the fields of oncology, ophthalmology, autoimmunity, and cardiovascular diseases.  Fourteen assets have entered into clinical development, four have entered Phase 3 clinical trials, two monoclonal antibodies have their New Drug Application (NDA) under review and have been granted with priority review status, and one, Tyvyt^® (sintilimab injection), is now approved for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL).

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. 

To learn more about Lilly, please visit us at www.lilly.com and https://newsroom.lilly.com/social-channels.

About Innovent Biologics' strategic collaboration with Eli Lilly and Company

Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent) in March 2015 announced one of the largest biotech drug development collaborations in China to date between a multi-national and domestic company. Under the terms of the agreement, Lilly and Innovent will collaborate on the development and potential commercialization of at least three cancer treatments over the next decade. In October 2015, they announced an expansion of their drug development collaboration. The Innovent and Lilly partnership is one of the most comprehensive strategic collaborations between a Chinese company and a multinational partner in terms of the scope and breadth ranging from discovery to commercialization and involving up to six therapeutic antibodies for cancers.

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