Innovent and Lilly Jointly Announce the China NMPA Approval of TYVYT® (sintilimab injection) in Combination with Gemcitabine and Platinum Chemotherapy as First-Line Therapy for People with Squamous Non-Small Cell Lung Cancer

Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Eli Lilly and Company (NYSE: LLY) today jointly announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection) in combination with gemcitabine and platinum chemotherapy as first-line therapy for people with unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC).

This is the third NMPA-approved indication of TYVYT® (sintilimab injection), following the approval in December 2018 for the treatment of relapsed or refractory classical Hodgkin’s lymphoma, and the approval in February 2021 for the first-line treatment of nonsquamous non-small cell lung cancer (nsqNSCLC). This is also the first regulatory approval of a PD-1/PD-L1 immunotherapy in combination with gemcitabine and platinum chemotherapy for the first-line treatment for people with sqNSCLC.

This new approval was based on a randomized, double-blind, Phase 3 clinical trial (ORIENT-12) which evaluated TYVYT® (sintilimab injection) or placebo in combination with GEMZAR® (gemcitabine) and platinum chemotherapy as first-line therapy for people with unresectable locally advanced or metastatic sqNSCLC.

Professor Caicun Zhou, head of the Oncology Department at Shanghai Pulmonary Hospital, stated: “Lung cancer is the leading cause (nearly 25%) of all cancer deaths, of which non-small cell lung cancer accounts for about 80 to 85 percent. Approximately 70 percent of patients with non-small cell lung cancer have unresectable tumors at the time of diagnosis, and 30 to 60 percent of patients with Stage I-III non-small cell lung cancer who undergo radical surgery subsequently have recurrence or distant metastasis. Over the past two decades, drug development for non-small cell lung cancer has been mainly focused on nonsquamous non-small cell lung cancer, while drug development for squamous non-small cell lung cancer has been relatively slow due to its unique epidemiology, histopathology and molecular biology. The ORIENT-12 study showed that, in the first-line treatment of patients with squamous non-small cell lung cancer, TYVYT® (sintilimab injection) in combination with gemcitabine and platinum chemotherapy demonstrated a statistically significant improvement in progression-free survival compared to placebo and gemcitabine and platinum chemotherapy. Meanwhile, although the median overall survival data was not yet mature, the TYVYT® (sintilimab injection) combination arm showed a potential overall survival benefit over chemotherapy alone. The approval of TYVYT® (sintilimab injection) provides a new clinical approach in China for the first-line treatment of advanced or metastatic squamous non-small cell lung cancer. We look forward to offering this new indication of TYVYT® (sintilimab injection) and helping to treat people with squamous non-small cell lung cancer in China.”

Dr. Yongjun Liu, President of Innovent, stated: “As one of the most life-threatening diseases, cancer has always been a key focus for the pharmaceutical companies, researchers and clinicians that help develop oncology treatments. Innovent is committed to discovering and developing innovative medicines for diseases with unmet medical needs. This approval of TVYYT® (sintilimab injection) in a third indication represents another remarkable achievement for our novel, high quality PD-1 inhibitor in cancer treatment. We are very excited about this approval, and we look forward to now offering this as a first-line treatment option for people with squamous non-small cell lung cancer.”

Dr. Hui ZHOU, Senior Vice President of Clinical Development of Innovent, stated: “In China, lung cancer has the highest incidence and mortality rate among all tumor types. Although treatment development has been advancing in recent years, there is still a large number of people with lung cancer that lack effective treatment options – particularly those with the squamous type. This new indication of TYVYT® (sintilimab injection) provides an additional first-line treatment option for people with squamous non-small cell lung cancer. We are hopeful that TYVYT® (sintilimab injection) will help many people with this type of cancer.”

Julio Gay-ger, Lilly China President and General Manager, stated: “Oncology is one of the most important strategic therapeutic areas for Lilly. In particular, we have been deeply rooted in lung cancer treatment for many years. We’re excited to see two new indications for TYVYT® (sintilimab injection) in combination with two Lilly classic anti-tumor drugs – pemetrexed and gemcitabine, respectively – and platinum chemotherapy as first-line therapy for people with non-small cell lung cancer, both approved this year by the NMPA within a few months of each other. We are committed to the development and commercialization of effective cancer therapies and devote ourselves to helping patients with more innovative products through independent R&D and strategic collaborations.”

Dr. Li WANG, Senior Vice President of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center, stated: “Results of multiple clinical studies show that immuno-oncology therapy has become one of the standard global treatment options for lung cancer due to its proven clinical efficacy and safety. The approval of this new indication has further demonstrated its potential to treat people with lung cancer. Lilly will continue to work closely with Innovent to further explore TYVYT’s clinical potential in other tumor types with the hopes of helping more cancer patients.”

Source: Innovent Biologics