Lilly’s lung cancer drug extends survival

Lilly has unveiled promising results from a Phase III study of a lung cancer treatment which showed improved overall survival in patients.

The news is a welcome relief to Lilly, which has endured a string of late-stage failures, and could bring hope for patients with non-small cell lung cancer (NSCLC), where survival times have scarcely advanced in recent years.

The VEGF-blocking drug failed to meet its primary endpoint in an earlier Phase III trial in breast cancer released last year, which had caused some analysts to fear ramucirumab would join Lilly's long list of failures.

But the new top-line data from the REVEL trial has rewarded the patience of Lilly's leaders, and the drug is now scheduled for submission to regulators later this year.

The REVEL trial looked at Lilly's ramucirumab in combination with chemotherapy in patients with second-line non-small cell lung cancer (NSCLC), and showed a statistically significant improvement in the primary endpoint of overall survival compared to the control arm of placebo plus docetaxel. A statistically significant improvement in progression-free survival was also observed.

The REVEL trial was in NSCLC patients whose disease has progressed after failure of prior platinum-based chemotherapy for locally advanced or metastatic disease. The study included non-squamous and squamous NSCLC patients. The most common ( > 5% incidence) Grade > 3 adverse events occurring at a higher rate on the ramucirumab-plus-docetaxel arm compared to the control arm were decreased white blood cell count (neutropenia/leukopenia), febrile neutropenia, fatigue/asthenia and hypertension.

"We are pleased with these Phase III data of ramucirumab in non-small cell lung cancer, which accounts for most cases of lung cancer - the leading cause of cancer-related mortality worldwide. Despite currently available therapies, there continues to be a need for new second-line treatment options for patients with lung cancer," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "REVEL 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 non-small cell lung cancer."

Ramucirumab is being studied in several Phase III and earlier-phase studies in multiple tumour types, both as a single agent and in combination with other therapies. It has already demonstrated improved overall survival and progression free survival in two studies in gastric tumours.

Analysts predict the drug could hit peak sales of $1-2 billion, depending on how extensively it is eventually used in lung cancer and other tumours. Top-line results for Phase III trials of ramucirumab in hepatocellular (liver) and colorectal cancer are expected later this year.

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