Eli Lilly announced Wednesday results from a late-stage trial showing that the experimental drug ramucirumab significantly improved overall survival in patients with second-line non-small-cell lung (NSCLC) versus placebo. The company said it plans to submit the first application including these data to regulatory authorities this year.
The REVEL study randomised more than 1200 patients with NSCLC whose disease has progressed after failure of prior platinum-based chemotherapy for locally advanced or metastatic disease to receive either ramucirumab or placebo, both in combination with docetaxel. As well as meeting the main goal of overall survival, Eli Lilly noted that ramucirumab showed a significant improvement in progression-free survival compared to placebo.
Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology, remarked that the trial "is the first positive Phase III study of a biologic in combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone in second-line [NSCLC]." The drugmaker indicated that it will present data from the REVEL trial at an upcoming medical meeting.
"These data reinforce our confidence in the overall ramucirumab development programme, in which we have several Phase III and earlier-phase studies in multiple tumour types, both as a single agent and in combination with other therapies," Gaynor added. In 2012, Eli Lilly reported that a Phase III trial of the drug as a monotherapy in patients with metastatic gastric cancer met its primary endpoint. The results of the REGARD study have formed the basis for regulatory submissions in the US and Europe.
Analysts estimate that ramucirumab has the potential to generate annual sales of $1.5 billion by 2020. However, BMO Capital Markets analyst Alex Arfaei expressed caution about the latest results, noting that the drug "needs to show at least (a) 2-3 month improvement in overall survival to be considered clinically meaningful."
Last year, Eli Lilly announced that ramucirumab given in combination with paclitaxel reached the main goal of a second Phase III trial in patients with advanced gastric cancer, while a further late-stage study in patients with locally recurrent or metastatic breast cancer failed to meet its primary endpoint. The company plans regulatory submission for the drug in gastric cancer in combination with paclitaxel in 2014, while top-line results from Phase III trials in hepatocellular and colorectal cancer are also expected this year.
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