Innovent Biologics (HKEX: 01801), a prominent biotech firm headquartered in Suzhou, China, and Eli Lilly & Co. (Nasdaq: LLY), a titan of the US pharmaceutical industry, have jointly declared a significant milestone in the Phase II clinical study known as ORIENT-2. The study focuses on the co-developed anti-programmed death-1 (PD-1) inhibitor, Tyvyt (sintilimab), for the treatment of second-line advanced or metastatic esophageal squamous cell carcinoma (ESCC). The randomized, controlled trial has successfully met its primary endpoints, demonstrating a significant enhancement in overall survival (OS) for patients. The safety profile of Tyvyt was found to be consistent with previous studies, with no new safety signals detected. These promising results are slated for presentation at the American Society of Clinical Oncology (ASCO) 2020 annual meeting.
Tyvyt received market approval from China’s National Medical Products Administration (NMPA) in December 2018 for the treatment of relapsed/refractory classic Hodgkin’s lymphoma (CHL). Following a price reduction, the drug was incorporated into the National Reimbursement Drug List (NRDL) in November 2019, marking it as the sole PD-1 inhibitor with insurance coverage in China. The NMPA accepted for review the market filing of Tyvyt in combination with Eli Lilly’s Alimta (pemetrexed disodium) and platinum for first-line non-squamous non-small cell lung cancer (nsqNSCLC) in April of this year. Moreover, the Phase III ORIENT-12 clinical study, which evaluates Tyvyt in conjunction with Gemzar (gemcitabine) and platinum chemotherapy for first-line advanced or metastatic squamous non-small cell lung cancer (sqNSCLC), recently reported achievement of its primary endpoint.
Subject to over 20 clinical trials, Tyvyt is under development for a range of solid tumors and hematological malignancies, showcasing Innovent Biologics and Eli Lilly & Co.’s commitment to advancing cancer care.
