Innovent Biologics and Eli Lilly Announce Phase III ORIENT-3 Trial Results of TYVYT® (Sintilimab Injection) in Second-Line Squamous Non-Small Cell Lung Cancer at AACR 2021

SAN FRANCISCO, U.S. and SUZHOU, China, April 13, 2021 /PRNewswire/ -- Innovent Biologics (Hong Kong Stock Exchange stock code: 01801), a biopharmaceutical company dedicated to the research, development, production, and sales of innovative drugs for the treatment of major diseases such as cancer, metabolic disorders, and autoimmune diseases, today jointly announced with Eli Lilly and Company (New York Stock Exchange ticker: LLY) that the results of the Phase III clinical study ORIENT-3 were presented in an oral report at the 2021 American Association for Cancer Research (AACR-2021) Annual Meeting held online.

ORIENT-3 is a randomized, open-label, multicenter, parallel-controlled Phase III clinical study evaluating sintilimab versus docetaxel as second-line treatment for advanced squamous non-small cell lung cancer (sqNSCLC). A total of 290 subjects who had failed first-line platinum-based chemotherapy were enrolled. Analysis results showed that, based on the primary analysis population (280 patients, excluding those in the docetaxel group who received immunotherapy before disease progression), Tyvyt^®(Sintilimab Injection) significantly prolonged overall survival (OS) compared with docetaxel, achieving the primary study endpoint. The median OS in the sintilimab and docetaxel groups was 11.79 and 8.25 months, respectively (HR=0.74, 95% CI: 0.56-0.96, P=0.02489). The investigator-assessed median progression-free survival (PFS) was 4.30 and 2.79 months, respectively (HR=0.52, 95% CI: 0.39-0.68, P<0.00001). The confirmed objective response rate (ORR) was 25.5% and 2.2%, respectively (P<0.00001). The safety profile was consistent with previously reported data for Tyvyt^®(Sintilimab Injection) The study results were consistent, with no new safety signals identified.

Professor Shi Yuankai, Principal Investigator of the ORIENT-3 study, Chairman of the China Cancer Foundation, and Vice President of the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, stated: “Globally, lung cancer ranks as the leading cause of cancer-related deaths, with non-small cell lung cancer (NSCLC) accounting for approximately 80% to 85% of cases. Over the past two decades, advancements in drug development for NSCLC have primarily focused on non-squamous NSCLC, while progress in squamous NSCLC has been relatively slow due to its distinct epidemiological, histopathological, and molecular biological characteristics. In China, treatment options for second-line immunotherapy are even more limited. The ORIENT-3 study confirms that sintilimab significantly improves overall survival in patients with second-line squamous NSCLC, holding substantial clinical significance. The success of the ORIENT-3 study will benefit a greater number of patients with squamous lung cancer.”

Dr. Zhou Hui, Vice President of the Medical Science and Strategic Oncology Department at Innovent Bio, stated: “Tyvyt^®(Sintilimab Injection) is the first anti-PD-1 monoclonal antibody drug included in the National Reimbursement Drug List. In August 2020, the National Medical Products Administration (NMPA) officially accepted the new indication application for Tyvyt® (Sintilimab Injection) in combination with chemotherapy as first-line treatment for squamous non-small cell lung cancer (NSCLC). The results of the ORIENT-3 study demonstrated that sintilimab, as a second-line monotherapy, significantly improved survival benefits in patients with advanced squamous NSCLC. We look forward to the expedited approval of this indication to benefit more Chinese lung cancer patients.

“These study results are exciting, demonstrating that Tyvyt”^®“Sintilimab injection significantly prolongs overall survival in this patient population. It also reaffirms the commitment of Eli Lilly and Innovent to providing innovative treatment options for patients with lung cancer,” said Dr. Li Wang, Senior Vice President of Eli Lilly China and Head of the Drug Development and Medical Affairs Center. “We would like to express our gratitude to all the participating patients, investigators, clinical trial centers, and our colleagues at Innovent. We look forward to making this treatment available to patients with squamous non-small cell lung cancer in China as soon as possible.”

About Squamous Non-Small Cell Lung Cancer

Lung cancer is currently the most prevalent malignant tumor in China, ranking first in both incidence and mortality. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of all lung cancer cases, and about 70% of NSCLC patients are diagnosed with locally advanced or metastatic disease that is not amenable to curative surgery. Meanwhile, a significant proportion of early-stage NSCLC patients who undergo surgical treatment experience recurrence or distant metastasis, ultimately leading to death due to disease progression. Approximately 30% of NSCLC patients in China have squamous NSCLC. In the second-line treatment of advanced squamous NSCLC, there are very limited options for immunotherapy drugs, and there remains a substantial unmet clinical need in the second-line treatment landscape for squamous NSCLC in China.

AboutORIENT-3 Study

The ORIENT-3 study is an evaluation of Tyvyt^®A Randomized, Open-Label, Multicenter, Parallel-Group, Phase III Clinical Study on the Efficacy and Safety of Sintilimab Injection as Second-Line Treatment for Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) (ClinicalTrials.gov, NCT 03150875). The primary endpoint was overall survival (OS), and secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety assessed by investigators according to RECIST v1.1 criteria.

A total of 290 subjects were enrolled in this study and randomized in a 1:1 ratio to receive Tyvyt, respectively.^®(Sintilimab Injection) 200 mg or docetaxel, administered once every 3 weeks until disease progression, intolerable toxicity, or other conditions requiring treatment discontinuation.

About Tyvyt^®(Sintilimab Injection)

Tyvyt^®(Sintilimab Injection) is an innovative, international-quality PD-1 inhibitor drug jointly developed by Innovent Biologics and Eli Lilly and Company in China. In December 2018, Tyvyt^®(Sintilimab Injection) was first approved by the NMPA for the treatment of relapsed or refractory classical Hodgkin lymphoma in patients who have received at least two lines of systemic chemotherapy. In February 2021, Tyvyt^®(Sintilimab Injection) Approved by NMPA in Combination with Pemetrexed and Platinum-Based Chemotherapy for First-Line Treatment of Non-Squamous Non-Small Cell Lung Cancer (nsqNSCLC). Tyvyt^®(Sintilimab Injection) was successfully included in the National Reimbursement Drug List (NRDL) in November 2019, becoming the first and only PD-1 inhibitor to enter the NRDL that year.

Currently, Tyvyt^®(Sintilimab Injection) Three additional supplemental new drug applications (“sNDAs”) for new indications have been accepted for review by the NMPA. In August 2020, the NMPA officially accepted Tyvyt^®(New Application for the Indication of Sintilimab Injection in Combination with Gemcitabine and Platinum-based Chemotherapy as First-line Treatment for Squamous Non-small Cell Lung Cancer). In January 2021, the NMPA officially accepted the application for Tyvyt.^®(Sintilimab Injection) in Combination with Byvasda^®(Bevacizumab Injection) New Indication Application for First-Line Treatment of Liver Cancer Patients and Tyvyt^®(Sintilimab Injection) for the new indication application for second-line treatment of squamous non-small cell lung cancer. In addition, in May 2020, Tyvyt^®The ORIENT-2 study of sintilimab injection as monotherapy for second-line treatment of advanced/metastatic esophageal squamous cell carcinoma also met its primary endpoint.

Tyvyt®^®(Sintilimab Injection) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to the PD-1 molecule on the surface of T cells, thereby blocking the PD-1/Programmed Death-Ligand 1 (PD-L1) pathway responsible for tumor immune escape. This mechanism reactivates the anti-tumor activity of lymphocytes, achieving the goal of tumor treatment. Currently, more than twenty clinical studies (including over ten registrational clinical trials) are underway to evaluate the anti-tumor efficacy of sintilimab in various solid tumors and hematologic malignancies. Innovent Bio is also conducting global clinical research on Sintilimab Injection.

About Innovent Bio

“Rooted in Trust, Realized through Action.” Innovent Bio’s vision and goal is to develop high-quality biologics that are affordable for the general public. Established in 2011, Innovent Bio is dedicated to the development, manufacturing, and commercialization of innovative medicines for the treatment of major diseases, including cancer, autoimmune disorders, and metabolic diseases. On October 31, 2018, Innovent Biologics (Suzhou) Co., Ltd. was listed on the Main Board of The Stock Exchange of Hong Kong Limited, with stock code: 01801.

Since its establishment, the company has stood out among numerous biopharmaceutical companies by leveraging innovative achievements and an internationalized operational model. It has built a product pipeline comprising 23 new drug candidates, covering multiple therapeutic areas including oncology, metabolic diseases, and autoimmune disorders. Among these, six candidates were selected for the National “Major New Drug Development” Special Program. Four products—Sintilimab Injection (brand name: TYVYT®; English trademark: TYVYT®), Bevacizumab Biosimilar (brand name: BYVASDA®; English trademark: BYVASDA®), Adalimumab Biosimilar (brand name: SULINNO®; English trademark: SULINNO®), and Rituximab Biosimilar (brand name: HALPRYZA®; English trademark: HALPRYZA®)—have received marketing approval from the National Medical Products Administration (NMPA). Five candidates have entered Phase III or pivotal clinical studies, and an additional 14 products have entered clinical development. Sintilimab was successfully included in the National Reimbursement Drug List (NRDL) in November 2019, becoming the only PD-1 inhibitor included in the updated NRDL at that time.

Innovent Bio has assembled a high-caliber team for the development and industrialization of biologics, featuring international advanced expertise and numerous overseas-returning experts. The company has established strategic collaborations with international partners including Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, and Hanmi Pharmaceutical. Innovent Bio is committed to working collectively to elevate the development level of China’s biopharmaceutical industry, thereby enhancing drug accessibility for the public and fulfilling people’s aspirations for better health and well-being. For more details, please visit the company’s website:www.innoventbio.com。

About Eli Lilly and Company

Eli Lilly and Company is a global leading pharmaceutical company dedicated to improving human health through innovation. Founded over a century ago, the company’s founder was committed to producing high-quality medicines to meet tangible medical needs. Today, Eli Lilly and Company remains steadfast in this mission and conducts its operations accordingly. Worldwide, employees of Eli Lilly and Company strive to discover and develop transformative medicines that improve people’s lives and make them available to patients who truly need them. Furthermore, Eli Lilly and Company is committed to enhancing public understanding of diseases and improving disease management, while giving back to society through philanthropy and volunteerism. For more information about Eli Lilly and Company, please visit:www.lilly.com。

Strategic Cooperation Between Innovent Bio and Eli Lilly

In March 2015, Innovent Bio and Eli Lilly and Company entered into a biopharmaceutical drug development collaboration, which remains one of the largest partnerships to date between a Chinese biopharmaceutical company and a multinational pharmaceutical corporation. Under the terms of the agreement, Innovent Bio and Eli Lilly and Company will jointly develop and commercialize in China, including Tyvyt^®oncology drugs, including sintilimab injection. In October 2015, the two parties announced a further expansion of their established drug development collaboration by adding three novel oncology therapeutic antibodies. In August 2019, the collaboration was extended to the field of diabetes, with Innovent Bio obtaining authorization to develop and commercialize in China a potential global best-in-class novel clinical-stage diabetes drug from Eli Lilly. These three collaborations with Eli Lilly and Company mark that Innovent Bio has established a comprehensive strategic partnership between a Chinese innovative pharmaceutical enterprise and a global pharmaceutical giant, covering new drug research and development, clinical studies, manufacturing quality, and marketing and sales. In August 2020, Innovent Bio and Eli Lilly and Company announced the expansion of Tyvyt^®(Strategic cooperation on sintilimab injection), Innovent Bio will grant Eli Lilly an exclusive license for sintilimab in regions outside of China, and Eli Lilly will be committed to promoting sintilimab in North America, Europe, and other regions.

Declaration:

1. This indication is an investigational use of the drug and has not yet been approved in China.

2. Innovent does not recommend the use of any unapproved drugs/indications

3. For communication among healthcare professionals only