Updated Results on Neoadjuvant PD-1 Blockade with Sintilimab in Resectable Squamous Non-Small Cell Lung Cancer (sqNSCLC) at ASCO, Led by Professor Jie He, Dean of the Cancer Hospital of the Chinese Academy of Medical Sciences

SUZHOU,China,June 3,2019 --The preliminaryresults of efficacy and safety of neoadjuvant PD-1 blockade with sintilimab in resectable squamous non-small cell lung cancer (sqNSCLC) (ChiCTR-OIC-17013726),led by Professor Jie He,Dean of the Cancer Hospital of the Chinese Academy of Medical Sciences,were presented by poster at the 55th annual meeting of the American Society of Clinical Oncology (ASCO).

Lung cancer is one of the malignant tumors with the high morbidity and mortality and non-small cell lung cancer (NSCLC) accounts for approximately 80%-85% of all lung cancer cases. NSCLC patients who have potentially resectable disease often subsequently relapse after surgery. New therapy that prevents relapse after surgery is desperately needed.

ChiCTR-OIC-17013726 (Abstract #8531; Sunday,June 2,8:00 AM -11:00 AM CDT),is an open-label,single-center,Phase Ib study in China,evaluating the efficacy and safety of neoadjuvant sintilimab for patients with resectable sqNSCLC in China.

As of 28 Jan 2019,22 patients with treatment-naïve resectable sqNSCLC (stage IB-IIIA) confirmed by histopathology and enhanced PET/CT scans have received two doses of sintilimab followed by radical resection.

Data from the clinical study show:

Based on the PET/CT reports,among the nine patients with >30% decrease in standardized uptake values (SUV),eight had a major pathologic response (MPR) (all eight patients showed a decrease in SUV to ≤ 10%); in the 11 patients with ≤ 30% decrease in SUV,none achieved MPR.

Ten patients (45.5%) achieved a major pathologic response (MPR with ≤10% viable tumor cells),including four (18.2%) who had complete pathologic response (no viable tumor cells). There was a direct correlation between MPR and a decrease in the SUV. The MPR may be predicted by the decrease in SUV in PET-CT after neoadjuvant therapy.

Neoadjuvant PD-1 blockade with sintilimab in resectable squamous (sqNSCLC) has an acceptable safety profile.

As the top and most influential international oncology conference,ASCO Annual Meeting provides the most important platform for publishing and discussing cutting edge clinical studies. Under the theme "Caring for Every Patient,Learning from Every Patient",2019 ASCO Annual Meeting has attracted numerous top oncologists,scholars,staff from regulatory and patient organizations to share the latest updates and achievements in clinical oncology,with the ultimate goal to help deliver more promising medicines and treatment options to cancer patients.

Tyvyt® (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. 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-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt® (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt® (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection,including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.