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Tyvyt® (Sintilimab Injection) Combined with ALIMTA® (Pemetrexed) and Platinum Met Predefined Primary Endpoint in Phase 3 ORIENT-11 Study as First-Line Therapy in Nonsquamous NSCLC

January 13, 2020 GMT
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INDIANAPOLIS, Jan. 13, 2020 /PRNewswire/ -- Today, Eli Lilly and Company (NYSE: LLY) jointly announced with Innovent Biologics, Inc. the results of a Phase 3 study in China; the ORIENT-11 trial of Tyvyt® (sintilimab injection) in combination with ALIMTA® (pemetrexed) and platinum in first-line advanced or recurrent nonsquamous non-small cell lung cancer (nsqNSCLC), without sensitive EGFR mutation or ALK rearrangement, met the predefined primary endpoint of progression-free survival (PFS) in an interim analysis.

Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), sintilimab in combination with ALIMTA and platinum demonstrated a statistically significant improvement in PFS compared with placebo in combination with ALIMTA and platinum, which met the pre-defined efficacy criteria. The safety profile of sintilimab in this trial was consistent with previously reported studies, and no new safety signals were identified.

Relevant data will be presented at an upcoming medical conference. Based on the IDMC recommendations, Lilly and Innovent will initiate regulatory discussions for registration with the National Medical Products Administration (NMPA) in China in the near future.

Professor Li Zhang, Head of the Department of Internal Medicine, Sun Yat-sen University Cancer Center, stated: “In 2019, the National Cancer Center published Chinese data on lung cancer from 2015, showing an incidence of 20 percent and a mortality rate of about 27 percent, ranking it first among all cancer types. Patients who have nsqNSCLC without sensitive EGFR mutation or ALK rearrangement need more treatment options. Treatment with an anti-PD-1 monoclonal antibody in combination with chemotherapy may bring a greater survival benefit to this patient population. We are glad to see that these findings from this trial of sintilimab met the predefined primary endpoint in the interim analysis.”

“We are excited about these results, which show Tyvyt plus ALIMTA and platinum significantly delayed disease progression in this patient population. This study is another example of the joint commitment from Lilly and Innovent to provide new treatment options to patients with lung cancer,” said Dr. Wang Li, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. “We would like to thank the patients, investigators and clinical trial sites that are participating in the study, and our colleagues from Innovent. We look forward to bringing this new treatment option to lung cancer patients in China.”

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences, Innovent, said: “So far, Tyvyt is the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List. It was officially approved by the NMPA on December 24, 2018 for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after at least second-line system chemotherapy. Currently, we have several ongoing Phase 3 randomized clinical trials in lung cancer. With the encouraging result of ORIENT-11 we anticipate that sintilimab has the potential to benefit more patients with lung cancer and provide them more time with their families.”

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 and platinum as first-line therapy for advanced or recurrent nsqNSCLC without sensitive EGFR mutation or ALK rearrangement (ClinicalTrials.gov, NCT03607539). The primary endpoint is progression-free survival (PFS) assessed by the Independent Radiographic Review Committee (IRRC) based on RECIST v1.1. The other secondary endpoints include overall survival (OS) and safety profile.

A total of 397 subjects have been enrolled in the ORIENT-11 trial and randomized in a 2:1 ratio to receive either sintilimab 200mg or placebo in combination with ALIMTA and platinum every three weeks for up to four 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 rates in China. NSCLC accounts for about 80 percent to 85 percent of lung cancers. 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 nonsquamous subtype and 50 percent of nsqNSCLC are without sensitive 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 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 second-line system chemotherapy, and is included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. Tyvyt is the only PD-1 inhibitor with global quality that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019.

Tyvyt 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 eight registration or pivotal clinical trials.

Tyvyt (sintilimab injection) is not an approved product in the United States. ALIMTA® (pemetrexed for injection) is not approved for use in combination with Tyvyt in the United States.

U.S. INDICATIONS FOR ALIMTA® (pemetrexed for injection)
ALIMTA is indicated:

U.S. IMPORTANT SAFETY INFORMATION FOR ALIMTA® (pemetrexed for injection)

CONTRAINDICATION

WARNINGS AND PRECAUTIONS

Myelosuppression and Increased Risk of Myelosuppression Without Vitamin Supplementation

Renal Failure

Bullous and Exfoliative Skin Toxicity

Interstitial Pneumonitis

Radiation Recall

Increased Risk of Toxicity With Ibuprofen in Patients With Renal Impairment

Embryo-Fetal Toxicity

DRUG INTERACTIONS

ADVERSE REACTIONS

USE IN SPECIFIC PATIENT POPULATIONS

PM_HCP_ISI_NSCLC1L_Combo_30JAN2019

For U.S. safety and dosing guidelines for ALIMTA, see complete Warnings and Precautions, Adverse Reactions, and Dosage and Administration sections in the full U.S. Prescribing Information and Patient Prescribing Information.

ALIMTA® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

About Lilly Oncology
For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. To learn more about Lilly’s commitment to people with cancer, please visit www.LillyOncology.com.

About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that 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 lilly.com and lilly.com/newsroom.

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, 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 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 a robust pipeline of 21 innovative assets in the fields of oncology, autoimmune, metabolic diseases and other major therapeutic areas, with sixteen in clinical development, five in Phase III clinical trials, three NDAs under review by 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 Innovent Biologics’ strategic cooperation with Eli Lilly and Company
Eli Lilly and Company launched a program focusing on biological medicine co-development with Innovent Biologics in March 2015 – a groundbreaking partnership between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement, Lilly and Innovent Biologics 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 antibodies targeting oncology indications. Its collaboration with Lilly indicates that Innovent Biologics has established a comprehensive level of cooperation between China’s innovative pharmaceuticals sector and the international pharmaceuticals sector in fields such as R&D, pipeline quality and commercial.

P-LLY

© Lilly USA, LLC 2019. ALL RIGHTS RESERVED.

Lilly Forward-Looking Statement
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the ORIENT-11 trial and Tyvyt® (sintilimab injection) in combination with ALIMTA®(pemetrexed) and platinum in first-line advanced or recurrent nonsquamous non-small cell lung cancer, and reflects Lilly’s current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that Tyvyt will receive regulatory approval for first-line advanced or recurrent nonsquamous non-small cell lung cancer or will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward- looking statements to reflect events after the date of this release.

Contact:

Media:
Innovent: pr@innoventbio.com; +86 512-6956 6088
Lilly: Carole Copeland; Carole_Copeland@Lilly.com; (317) 610-6196

Investors:
Innovent: ir@innoventbio.com; +86 512-6956 6088
Lilly: Kevin Hern; hern_kevin_r@lilly.com; (317) 277-1838

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