Eli Lilly and Co. said its lung cancer drug Cyramza extended patients' lives without their disease worsening in a late-stage study.
The phase 3 trial, called Relay, was evaluating Cyramza, combined with Roche Holding AG's Tarceva, as a first-line treatment for patients with non-small cell lung cancer whose diseases have spread across the body and whose tumors have activating mutations in the epidermal growth factor receptor gene.
Under the study, patients taking the Cyramza combination showed a statistically significant improvement in progression-free survival, or the amount of time a patient stays alive without the disease worsening, compared to those taking placebo and Tarceva — the trial's main goal.
The therapy's safety profile was also consistent with previous trials, with the most common side effects in patients given Cyramza being hypertension, acne-like rashes and diarrhea.
Indianapolis-based Lilly plans to start global regulatory submissions for Cyramza in the lung cancer indication in the middle of 2019.
Cyramza, also known as ramucirumab, has been studied in gastric cancer, non-small cell lung cancer and colorectal cancer — three indications in which it is already approved in the U.S. The company is also seeking approvals in the U.S., EU and Japan for Cyramza as a second-line treatment for patients with a type of liver cancer.
The company continues to study the treatment in other tumor types, including bladder cancer.