Eli Lilly (LLY) and Innovent Biologics have announced positive interim results from the ORIENT-12 study at the European Society of Medical Oncology (ESMO) Virtual Congress 2020.
ORIENT-12 is the first randomized, double-blind, Phase 3 clinical trial evaluating TYVYT (sintilimab injection) or placebo with GEMZAR (gemcitabine) and platinum chemotherapy as first-line treatment for advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). A total of 357 subjects were enrolled.
In the interim analysis, TYVYT with GEMZAR and platinum chemotherapy demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo, meeting the pre-specified primary endpoint.
The updated analysis demonstrated that the median PFS assessed by IRRC was 5.5 months in the sintilimab combination arm versus 4.9 months in the placebo combination arm, while the median PFS assessed by the investigators was 6.7 months in the sintilimab combination arm versus 4.9 months in the placebo combination arm.
The interim analysis suggested that the median overall survival (OS) data was not yet mature, but the sintilimab combination arm potentially showes an OS benefit over the placebo combination arm. The safety profile was consistent with that in previously reported studies with sintilimab, and no new safety signals were identified.
Professor Caicun Zhou, of Shanghai Pulmonary Hospital, stated: “ORIENT-12 is the first Phase 3 study to demonstrate a progression-free survival benefit by treatment with a PD-1 inhibitor in combination with gemcitabine and platinum chemotherapy for the first-line treatment of squamous NSCLC.”
“The results of this study show a great clinical value… We are hopeful that the positive results of ORIENT-12 can help more squamous NSCLC patients” he added.
Indeed, lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 to 85% of lung cancer. Approximately 70% of people with NSCLC have locally advanced or metastatic NSCLC at initial diagnosis, rendering the patients with no chance of radical resection.
TYVYT is being jointly developed in China by Innovent and Lilly, and has already been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy.
It is an immunoglobulin G4 monoclonal antibody, which can bind to PD-1 molecules on the surface of T-cells, block the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivate T-cells to kill cancer cells.
Shares in LLY are up more than 17% year-to-date and the stock scores a bullish Strong Buy Street consensus. That’s with a $173.75 average analyst price target, indicating 13% upside potential lies ahead.
Morgan Stanley analyst David Risinger recently raised the stock to Buy from Hold and ramped up the price target to $176 from $157, citing long-term growth prospects, positive Phase 3 tirzepatide results starting in 4Q and a rise in positive sentiment for its Alzheimer’s pipeline.
“Lilly’s Alzheimer’s pipeline represents an inexpensive call option, in our view,” Risinger wrote in a note to investors. (See LLY stock analysis on TipRanks).
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