• Eli Lilly’s anti-angiogenic therapy Cyramza met the primary endpoint of a late-stage study, improving progression-free survival in previously untreated patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations.
• The global study compared the combination of Cyramza and the targeted therapy Tarceva with Tarceva alone, a standard of care in this type of lung cancer. Lilly will present further results at a medical meeting this year.
• This is the second positive Phase 3 study of Cyramza in metastatic NSCLC. The first, named REVEL, supported Cyramza’s current indication as second-line treatment for the disease. Lilly plans to begin global regulatory submissions for the first-line setting in mid-2019.

In recent years, the Food and Drug Administration has approved several therapies for EGFR-mutated non-small cell lung cancer, including AstraZeneca’s Tagrisso (osimertinib) and, most recently, Pfizer’s Vizimpro (dacomitinib).

Tagrisso, cleared by the FDA as a first-line treatment for these patients, is proving particularly valuable for AstraZeneca. Sales of the tyrosine kinase inhibitor nearly doubled in 2018, climbing to $1.86 billion. Tagrisso is also approved in the second-line setting, but for patients who express a specific EGFR mutation called T790M.

Cyramza (ramucirumab) is also approved for second-line NSCLC, in combination with docetaxel. The Lilly drug raked in $821 million last year, which included $530 million in ex-U.S. sales. Though that performance represents an 8% increase over 2017, a first-line approval could give Lilly an additional boost as it works to catch up with Tagrisso.

“Despite recent treatment advances in metastatic EGFR-mutated non-small cell lung cancer, prognosis remains poor and there is an ongoing need for additional first-line treatment options to help patients with this deadly disease,” said Maura Dickler, vice president of late-phase development at Lilly Oncology, in a March 12 statement.

Outside of lung cancer, Cyramza is pending approval in the U.S., European Union and Japan as a second-line treatment for hepatocellular carcinoma, based on its Phase 3 REACH-2 results. In that study, Cyramza met both its overall survival and progression-free survival objectives in certain high-risk patients.