On January 12, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) 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 (Press release, Innovent Biologics, JAN 12, 2020, View Source [SID1234553035]).

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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, Innovent and Lilly will initiate regulatory discussions for registration with the National Medical Products Administration (NMPA) in China in the near future.

Professor Li Zhang, Head of 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."

"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," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent. "Currently, we have several phase 3 randomized clinical trials ongoing 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 more time with their families."

"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 to our colleagues from Innovent. We look forward to bringing this new treatment option to Chinese lung cancer 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 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 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 ORIENT-11 trial and randomized in a 2:1 ratio to receive either sintilimab 200mg or placebo in combination with ALIMTA 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 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 included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) 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 (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 eight registration or pivotal clinical trials.