Eli Lilly’s Phase 3 RELAY study of Cyramza (ramucirumab) showed improvement in the time patients lived without their cancer growing or spreading after starting treatment, the company said Tuesday.
The Phase 3 global, randomized, double-blind trial is evaluating Cyramza in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have activating EGFR mutations, the company noted in the press release.
The company said that the detailed efficacy and safety results will be submitted for presentation at a medical meeting in 2019.
In the announcement, the company also pointed out that there is no cure for people with metastatic lung cancer. The disease is associated with low survival rates and disease progression following acquired resistance remains a challenge. Most patients receive several lines of treatment and the therapeutic regimen prescribed for first-line treatment can impact a person’s options for later lines of treatment. Tyrosine kinase inhibitors (TKIs) are the current standard treatment option for EGFR-mutated NSCLC. Erlotinib, the TKI included in the RELAY trial regimen, is a globally recognized standard of care for this type of lung cancer, Eli Lilly said in its announcement.
“We are excited about these results, which show Cyramzac plus erlotinib significantly delayed disease progression in this patient population. The RELAY trial is another example of Lilly’s deep commitment to providing new treatment options to patients with lung cancer,” said
Maura Dickler, M.D., vice president of late phase development, Lilly Oncology.
Lilly said it plans to begin the global regulatory submissions in mid-2019.