Eli Lilly (LLY) and Innovent Biologics have announced that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for TYVYT (sintilimab injection) in combination with Gemzar (gemcitabine) and platinum as first-line therapy in squamous non-small cell lung cancer (squamous NSCLC).
Recently, the NMPA accepted sNDA for TYVYT (sintilimab injection) as first-line therapy in non-squamous NSCLC on Apr 23, 2020.
The sNDA was based on the analysis of a randomized, double-blind, Phase 3 clinical study (ORIENT-12) of 357 patients, which demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo. The safety profile was also consistent with previously reported sintilimab studies.
Professor Caicun Zhou, Head of Department of Oncology, Shanghai Pulmonary Hospital, stated: “We are pleased to see that sintilimab in combination with chemotherapy has met predefined primary endpoint in ORIENT-12 study. There still exists large unmet medical needs in squamous NSCLC patients. Globally, ORIENT-12 has demonstrated for the first time survival benefit by treatment with PD-1 inhibitor in combination with gemcitabine and platinum in first-line squamous NSCLC.”
Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for approximately 80-85% of all lung cancer diagnosis- and about 35% of patients with NSCLC in China are of squamous subtype without driver genes.
TYVYT (sintilimab injection), is being jointly developed in China by Lilly and Innovent, and has already been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after at least two lines of systemic chemotherapy.
It 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.
Shares in LLY are up 15% year-to-date and analysts have a cautiously optimistic Moderate Buy consensus on the stock’s outlook. That’s alongside a $173 average analyst price target (14% upside potential).
“We see Lilly as a best-in-class story but have remained Neutral on the stock given the premium multiple at which it has been trading” commented Mizuho Securities analyst Vamil Divan on August 3, after the company delivered an ‘admittedly messy 2Q20.’ Results were negatively impacted by the COVID-19 pandemic but boosted by higher Other Income, lower expenses and a lower tax rate.
Divan has a $164 price target on LLY, but notes that he could become more constructive on the stock ahead of upcoming catalysts if the current weakness persists. (See LLY stock analysis on TipRanks).
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