Eli Lilly (LLY) and Innovent Biologics have announced encouraging interim analysis data from ORIENT-11 at the virtual IASLC World Conference on Lung Cancer (WCLC) 2020.
The randomized, double-blind, Phase 3 clinical trial of 397 patients assessed TYVYT (sintilimab injection) with ALIMTA (pemetrexed) and platinum chemotherapy as a first-line treatment for nonsquamous non-small cell lung cancer (nsqNSCLC) without sensitive EGFR mutation or ALK rearrangement.
Based on interim analysis by an independent committee, the treatment demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo, which met the pre-defined efficacy criteria.
After a median follow up of 8.9 months, the median PFS of the sintilimab combination and the placebo combination assessed by the Independent Radiographic Review Committee (IRRC) was 8.9 months and 5.0 months, respectively. The median overall survival (OS) was not reached in both groups, but OS showed an improvement favoring the sintilimab combination. Confirmed objective response rate was improved from 29.8% to 51.9%, and the sintilimab combination showed a shorter time to response (1.51 months vs 2.63 months for the placebo combination).
The safety profile was consistent with previously reported sintilimab studies, and no new safety signals were identified.
National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for this indication.
Dr. Li Wang, Senior VP of Lilly China, stated: “With these encouraging results of ORIENT-11, sintilimab may soon be able to expand its indication to the first-line treatment of non-squamous NSCLC. We look forward to its potential approval in China, with the goal of helping more patients with lung cancer and giving these patients and their families hope of a longer life.”
Indeed, lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 to 85% of lung cancer. About 70% of NSCLC in China is the nonsquamous subtype and 50% of nsqNSCLC is without sensitizing EGFR mutations or ALK rearrangements. These patients do not respond well to targeted therapy and there are limited treatment options available to them.
TYVYT (sintilimab injection) is being jointly developed in China by Innovent and Lilly, and has already been granted marketing approval for relapsed or refractory classic Hodgkin’s lymphoma after systemic chemotherapy. It is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells and reactivates T-cells to kill cancer cells.
Shares in LLY are up 16% 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 (13% 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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