Plus   Neg

Merck: Phase III JAVELIN Lung 200 Trial With Avelumab Fails To Meet Endpoint

Merck KGaA (MKGAY.PK) and Pfizer Inc. (PFE) announced results from the Phase III JAVELIN Lung 200 trial comparing avelumab to docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer whose disease progressed after treatment with a platinum-containing doublet therapy. The company said, while the trial did not meet its prespecified endpoint of improving overall survival in patients with programmed death ligand-1-positive tumors, the proportion of patients in the chemotherapy arm crossing over to immune checkpoint inhibitors outside the study was higher than previously reported in post-platinum immunotherapy clinical trials, and this may have confounded the trial outcome.

The company said the safety profile for avelumab in the trial was consistent with that observed in the overall JAVELIN clinical development program; no new safety signals were identified.

"When the primary endpoint is not met, statistical significance cannot be formally claimed with the predefined statistical significance level. In this circumstance, the Type I error is not strictly controlled and the p-value should be interpreted cautiously," the company said.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Conagra Brands, Inc. (CAG) reported that its third-quarter adjusted earnings per share from continuing operations grew 27.1% to $0.61 from $0.48, prior year. On average, 14 analysts polled by Thomson Reuters expected the company to report profit per share of $0.56 for the quarter. Analysts' estimates typically exclude special items. Aided by a lower effective tax rate, earnings per share from continuing operations grew 112.2% to $0.87 from $0.41, a year ago. Saudi Arabia's oil major Aramco is reportedly planning to list its much hyped initial public offering on the Saudi stock market, Tadawu only. Earlier, the Dhahran-based Saudi Arabian national petroleum company was planning for a wider international listing. Following a disastrous week of public-relations fiascoes involving transportation of pets, United Airlines said Tuesday it is suspending its Petsafe program with immediate effect. PetSafe is United Airlines' specially designed program for transporting animals that are not eligible to travel in the aircraft cabin. The program offers airport-to-airport travel for animals to nearly 300 destinations.
comments powered by Disqus
Follow RTT