Date: 14-Aug-2020

China NMPA Accepts Innovent & Eli Lillys SNDA For Tyvyt In Combo With Gemcitabine And Platinum As First Line Therapy In Squamous NSCLC

Innovent Biologics Inc, a world-class biopharmaceutical company, jointly announced with Eli Lilly and Company 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.

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."

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.

ORIENT-12 study is a randomized, double-blind, 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 (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.

ORIENT-11 study is a randomized, double-blind, 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 (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.

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.

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.