US FDA Accepts Innovent & Lillys BLA For Sintilimab In Combo With Pemetrexed And Platinum Chemotherapy To Treat NSCLC

Innovent Biologics Inc and Eli Lilly and Company jointly announced that the US Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC). This is the first US regulatory submission of sintilimab, a PD-1 inhibitor being developed and commercialized under a global collaboration agreement between Innovent and Lilly."The acceptance of this application – the first for sintilimab in the US and outside of China – is an important milestone in Innovent's global commercialization strategy and in our collaboration with Lilly," said Dr. Yongjun Liu, president of Innovent. "We look forward to working closely with the US FDA to potentially bring this sintilimab-pemetrexed-platinum chemotherapy combination as a treatment option in the US, following the regimen's regulatory approval in China earlier this year."Sintilimab is currently being evaluated in a wide variety of cancer types under a broad clinical development program. To date, sintilimab has two indications approved in China, three regulatory submissions under review in China, and this regulatory application under review in US. This regulatory application was submitted to the US FDA in March 2021, primarily based on the results of the phase 3 ORIENT-11 trial. The Prescription Drug User Fee Act (PDUFA) goal date for the US FDA to make a decision on the sintilimab application is in March 2022. The US FDA stated that it did not identify any potential review issues in its acceptance letter. It is currently planning to hold an Advisory Committee meeting to discuss this application."We are pleased the sintilimab submission is progressing. Our pursuit of this proposed indication in the US reinforces Lilly's and Innovent's joint commitment to offer additional therapeutic options for people living with lung cancer and the healthcare providers who treat them," said Anne White, president, Lilly Oncology. "This is an encouraging start for our collaborative efforts to make sintilimab available in countries beyond China, as we continue to pursue opportunities globally for this immuno-oncology medicine across various tumor types."ORIENT-11 trial is a randomized, double-blind, phase 3 clinical trial assessing the efficacy and safety of sintilimab in combination with pemetrexed and platinum chemotherapy compared to placebo in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC), with no sensitizing EGFR mutations or ALK rearrangements. The primary endpoint is progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1, and secondary endpoints include overall survival (OS) and safety profile.A total of 397 patients were enrolled and randomized 2:1 to receive either sintilimab 200mg or placebo in combination with pemetrexed and platinum chemotherapy every three weeks for up to four cycles, followed by either sintilimab or placebo plus pemetrexed maintenance therapy. Patients received treatment until radiographic disease progression, unacceptable toxicity or any other conditions that required treatment discontinuation.Globally, lung cancer is the leading cause of cancer death, killing nearly 1.8 million people worldwide each year. In the US, lung cancer is the second most common cancer (not counting skin cancer) and the leading cause of cancer death, responsible for nearly 25 percent of all cancer deaths – more than those from colorectal, breast and prostate cancers combined. Non-small cell lung cancer (NSCLC) accounts for approximately 85 percent of all lung cancers, and about 70 percent of those with NSCLC have the nonsquamous subtype. Fifty percent of NSCLC patients present with advanced or metastatic disease at diagnosis.Sintilimab, marketed as Tyvyt (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Lilly. Sintilimab 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 of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.In China, sintilimab has been approved for treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy and in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer.Additionally, Innovent currently has regulatory submissions under review in China for sintilimab in combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer, and in combination with Byvasda (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma.The second-line treatment of squamous non-small cell lung cancerIn May 2021, the US FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.Sintilimab was included in China's National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

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