Innovent and Eli Lilly Announce NMPA Acceptance of a Supplemental New Drug Application for Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum as First-Line Therapy in Non-squamous NSCLC

SUZHOU, China, April 24, 2020 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic 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 ALIMTA® (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (nsqNSCLC). Tyvyt® was officially approved by the NMPA in December 2018 for the treatment of relapsed or refractory classical Hodgkin's lymphoma after at least two lines of systemic chemotherapy, and has been the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List (NRDL) since November 2019.

The NDA was based on the pre-specified interim analysis of a randomized, double-blind, Phase 3 clinical trial (ORIENT-11)—Tyvyt® (sintilimab injection) or placebo in combination with ALIMTA® and platinum as first-line therapy for advanced or recurrent nsqNSCLC without sensitizing EGFR mutation or ALK rearrangement. Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), Tyvyt® in combination with ALIMTA® and platinum demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo in combination with ALIMTA® and platinum, which met the pre-defined efficacy criteria. After a median follow up of 8.9 months, the median PFS of the experimental group and the control group assessed by Independent Radiographic Review Committee was 8.9 months and 5.0 months respectively, HR (95%CI) = 0.482 (0.362,0.643), P < 0.00001. 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 Li ZHANG, Head of Department of Internal Medicine, Sun Yat-sen University Cancer Center, the primary investigator of ORIENT-11 study, stated: "Nearly half of Chinese nsqNSCLC patients lack sensitizing EGFR mutation or ALK rearrangement, which makes them do not respond to targeted therapy.  ORIENT-11 study has demonstrated a significant delay of disease progression brought by sintilimab in combination with chemotherapy in this patient population."

Dr. Hui ZHOU, Vice President of Medical Science and Strategy Oncology of Innovent, stated: "The morbidity and mortality of lung cancer both rank first among all types of cancers in China. Despite treatment advances, there remains significant unmet needs for additional effective treatment options for lung cancer patients. The acceptance of NDA by the NMPA represents an important progress in demonstrating the potential value of Tyvyt® in lung cancer. We will actively cooperate with the regulatory authority to bring the high quality therapy to more patients with advanced non-squamous NSCLC as soon as possible."

"The intention of Lilly's strategic cooperation with Innovent is to bring new anti-tumor treatments, developed with global standards, to patients in China. As the success of this partnership, Tyvyt® is the only anti-PD-1 monoclonal antibody included in the NRDL for relapsed or refractory classical Hodgkin's lymphoma," said Dr. Li WANG, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. "With the encouraging result of ORIENT-11, Tyvyt® may soon expand its indication to lung cancer. In the future, we will strengthen cooperation with Innovent to further explore Tyvyt's potential in the field of immuno-oncology therapy and how Tyvyt® may bring benefits to more patients."

About ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial 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 nsqNSCLC 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 trial 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.

About nsqNSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 percent to 85 percent of lung cancer. Approximately 70 percent of NSCLC are locally advanced or metastatic at initial diagnosis, rendering the patients with no chance of radical resection. Meanwhile, even after radical surgery patients still have a high chance of recurrence and eventually die from disease progression. About 70 percent of NSCLC in China are non-squamous subtype and 50 percent of nsqNSCLC are without sensitizing EGFR mutation or ALK rearrangement. These patients do not respond well to targeted therapy and there are limited treatment options available to them.

About Tyvyt® (Sintilimab Injection)

Tyvyt® (sintilimab injection), an innovative drug developed with global quality standards jointly developed in China by Innovent and Lilly, 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® is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019.

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 trials.

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 mult-ifunctional 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, autoimmune, metabolic diseases and other major therapeutic areas, with 16 in clinical development, 5 in Phase 3 or pivotal clinical trials, 3 under NDA reviews by the NMPA with priority review status, while Tyvyt®, officially approved for marketing in China in 2018, 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, 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 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 Innovent Biologics' strategic cooperation with Eli Lilly and Company

Innovent entered into a strategy collaboration with Lilly focused on biological medicine in March 2015 – a groundbreaking partnership between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement, Innovent and Lilly will co-develop and commercialize oncology medicines, including Tyvyt® in China. In October 2015, the two companies announced the extension of their existing collaboration to include co-development of three additional oncology 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 trial, which hasn't been approved in China.
2. Innovent does not recommend any off-label usage.

Related Links :

http://www.innoventbio.com

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