Lilly has chalked up another positive phase III trial for late-stage cancer treatment ramucirumab, this time showing a benefit in non-small cell lung cancer (NSCLC).
Ramucirumab is one of the top prospects in Lilly’s pipeline – with consensus analyst forecasts of sales in excess of $1bn a year at peak – and is already under priority review in the US as a treatment for gastric cancer.
In the latest study, ramucirumab was given on top of docetaxel as a second-line therapy for NSCLC in patients who had already progressed after platinum-based chemotherapy.
Lilly’s drug – a VEGF receptor 2 inhibitor which is designed to block blood vessel growth in tumours – was able to improve both progression-free survival (PFS) and overall survival (OS) compared to docetaxel and placebo in the 1,200-patient REVEL trial.
The pharma company is not releasing any data from the trial until it can present the results at a scientific conference later this year, so the size of the survival benefit has yet to be revealed.
Nevertheless, senior vice president, product development and medical affairs for Lilly Oncology – Richard Gaynor – said REVEL is the first phase III study of a biologic in combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone in second-line NSCLC.
“Despite currently available therapies, there continues to be a need for new second-line treatment options for patients with lung cancer,” he added.
Lilly said it would add submit the NSCLC data for approval later this year, and is also expecting results of trials in colorectal and liver cancer. It stopped development of the drug in breast cancer last year, however, after disappointing clinical results.
Ramucirumab could be approved in the US as early as April for the treatment advanced gastric cancer following disease progression after initial chemotherapy.
The drug is one of a clutch of new products Lilly is hoping will restore revenue growth after patent expiries for big-selling brands such as antidepressant Cymbalta (duloxetine), along with a biosimilar version of Sanofi’s Lantus (insulin glargine) and diabetes therapies dulaglutide and empagliflozin.




