Innovent and Eli Lilly Announce Acceptance of a Supplemental New Drug Application of TYVYT® (Sintilimab Injection) in Combination with Gemcitabine and Platinum as First-Line Therapy in Squamous Non-Small Cell Lung Cancer in China
SUZHOU,China,Aug. 12,2020 --Innovent Biologics,Inc. ("Innovent") (HKEX: 01801),a world-class biopharmaceutical company that develops,manufactures and commercializes high quality medicines for the treatment of oncology,metabolic,autoimmune and other major diseases,today jointly announced with Eli Lilly and Company ("Lilly",NYSE: LLY) that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection) in combination with Gemzar® (gemcitabine) and platinum as first-line therapy in squamous non-small cell lung cancer (squamous NSCLC).Recently,the NMPA accepted sNDA for TYVYT® (sintilimab injection) as first-line therapy in non-squamous NSCLC on Apr 23,2020.
The sNDA was based on the analysis of a randomized,double-blind,Phase 3 clinical study (ORIENT-12)—TYVYT® (sintilimab injection) or placebo in combination with Gemzar® (gemcitabine) and platinum as first-line therapy for advanced or metastatic squamous NSCLC. Based on the analysis conducted by the Independent Data Monitoring Committee (IDMC),TYVYT® (sintilimab injection) in combination with Gemzar® (gemcitabine) and platinum demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo in combination with Gemzar® (gemcitabine) and platinum,which met the pre-defined efficacy criteria. The safety profile is consistent with previously reported sintilimab studies,and no new safety signals were identified. Detailed data will be released in an upcoming international academic conference and journal.
Professor Caicun Zhou,Head of Department of Oncology,Shanghai Pulmonary Hospital,stated: "We are pleased to see that sintilimab in combination with chemotherapy has met predefined primary endpoint in ORIENT-12 study. There still exists large unmet medical needs in squamous NSCLC patients. Globally,ORIENT-12 has demonstrated for the first time survival benefit by treatment with PD-1 inhibitor in combination with gemcitabine and platinum in first-line squamous NSCLC. The result of this study has great clinical value."
Dr. Hui ZHOU,Vice President of Medical Science and Strategy Oncology of Innovent,stated: "For Innovent,this is the second double-blind,randomized Phase 3 study of NSCLC that met primary endpoint following ORIENT-11,a randomized Phase 3 study of 1L non-squamous NSCLC (NCT03607539). This is also the second sNDA of TYVYT® (sintilimab injection) for first-line NSCLC indication. The acceptance of the sNDA by NMPA represents further progress in covering first-line NSCLC disease area. We will actively cooperate with the regulatory authority to bring the high quality therapy to more patients with advanced squamous NSCLC as soon as possible."
"Lilly and Innovent are committed to bring new anti-tumor treatments,developed with global standards,to patients in China. TYVYT® (sintilimab injection) is the first success of this partnership. After being included in the NRDL for relapsed or refractory classical Hodgkin's lymphoma,the acceptance of the sNDA for new indication of NSCLC is another important milestone of TYVYT® (sintilimab injection) in the field of oncology therapy," said Dr. Li WANG,Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. "ORIENT-12 provides new combination option of chemotherapy for squamous NSCLC patients and we look forward to bringing this new treatment solution to lung cancer patients in China as soon as possible. In the future,we will continue to strengthen cooperation with Innovent to further explore TYVYT® (sintilimab injection)'s potential in the field of immuno-oncology therapy and the potential benefits TYVYT® (sintilimab injection) may bring to more patients."
About squamous NSCLC
Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for approximately 80-85% of all lung cancer diagnosis. About 70% of NSCLC are locally advanced or metastatic at initial diagnosis,rendering the patients with no chance of radical resection. Meanwhile,even after radical surgery the patients still have a high chance of recurrence and eventually die from disease progression. About 35% of patients with NSCLC in China are of squamous subtype without driver genes. There are limited treatment options available to them.
About ORIENT-12 Study
ORIENT-12 is a randomized,Phase 3 clinical study to evaluate the efficacy and safety of TYVYT® (sintilimab injection) or placebo in combination with Gemzar® (gemcitabine) and platinum as first-line therapy for advanced or metastatic squamous NSCLC (ClinicalTrials.gov,NCT03629925). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee based on RECIST v1.1. The key secondary endpoints include overall survival (OS) and safety profiles.
A total of 357 subjects have been enrolled in ORIENT-12 study and randomized at a 1:1 ratio to receive either sintilimab 200mg or placebo in combination with Gemzar® (gemcitabine) and platinum every 3 weeks for up to 4 or 6 cycles,followed by either sintilimab or placebo maintenance therapy. The subjects will receive treatment until radiographic disease progression,unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.
About ORIENT-11 Study
ORIENT-11 is a randomized,Phase 3 clinical study to evaluate the efficacy and safety of TYVYT® (sintilimab injection) or placebo in combination with ALIMTA® (pemetrexed) and platinum as first-line therapy for advanced or recurrent non-squamous NSCLC without sensitizing EGFR mutation or ALK rearrangement (ClinicalTrials.gov,NCT03607539). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee based on RECIST v1.1. The key secondary endpoints include overall survival (OS) and safety profile.
A total of 397 subjects have been enrolled in ORIENT-11 study and randomized in a 2:1 ratio to receive either sintilimab 200mg or placebo in combination with ALIMTA® (pemetrexed) and platinum every 3 weeks for up to 4 cycles,followed by either sintilimab or placebo plus ALIMTA® maintenance therapy. The subjects will receive treatment until radiographic disease progression,unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.
This study has met primary endpoint and NMPA accepted the sNDA for TYVYT® (sintilimab injection) as first-line therapy in non-squamous NSCLC on Apr 23,2020.
About TYVYT® (Sintilimab Injection)
TYVYT® (sintilimab injection),an innovative drug developed with global quality standards jointly developed in China by Lilly and Innovent,has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin's lymphoma after at least two lines of 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.
In April 2020,the NMPA accepted the sNDA for TYVYT® (sintilimab injection) in combination with ALIMTA® (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (NSCLC). In May 2020,TYVYT® (sintilimab injection) combined with Gemzar® (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC,and TYVYT® (sintilimab injection) monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well. In August,the NMPA accepted the sNDA for TYVYT® (sintilimab injection) in combination with Gemzar® (gemcitabine for injection) and platinum chemotherapy as first-line therapy in patients with locally advanced or metastatic squamous NSCLC.
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 for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications,including more than 10 registration or pivotal clinical studies. Meanwhile,we are actively developingTYVYTglobally.
About Innovent
Inspired by the spirit of "Start with Integrity,Succeed through Action," Innovent's mission is to develop,manufacture 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,autoimmune,metabolic 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 its inception,Innovent has developed a fully-integrated multi-functional platform which includes R&D,CMC (Chemistry,Manufacturing,and Controls),clinical development and commercialization capabilities. Leveraging the platform,the company has built a robust pipeline of 23 valuable assets in the fields of oncology,metabolic diseases and other major therapeutic areas,with 19 in clinical development,5 in Phase 3 or pivotal clinical studies,2 under NDA reviews with priority review status by the NMPA,while 2 products,TYVYT® (sintilimab injection) and BYVASDA® (bevacizumab injection),officially approved for marketing in China. TYVYT® (sintilimab injection) has been the only PD-1 inhibitor included in the NRDL since 2019.
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,Alector,Hanmi and other international pharmaceutical companies. 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 create medicines 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 http://newsroom.lilly.com/social-channels.
About Eli Lilly and Company's strategic cooperation with Innovent Biologics
Lilly entered into a strategy collaboration with Innovent focused on biological medicine in March 2015 – a groundbreaking partnership between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement,Lilly and Innovent will co-develop and commercialize oncology medicines,including TYVYT® (sintilimab injection) in China. In October 2015,the two companies announced the extension of their existing collaboration to includeco-development of three additionaloncology antibodies targeting oncology indications. In August 2019,Innovent further entered a licensing agreement with Lilly to develop and commercialize a potentially global best-in-class diabetes medicine in China. Its collaboration with Lilly indicates that Innovent has established a comprehensive level of cooperation between China's innovative pharmaceuticals sector and the international pharmaceuticals sector in fields such as R&D,CMC,clinical development and commercialization.
Disclaimer:
1. This indication is still under clinical study,which hasn't been approved in China.
2. Lilly does not recommend any off-label usage.
