FDA approves Cyramza regimen for certain patients with metastatic NSCLC
The FDA approved ramucirumab in combination with erlotinib for first-line treatment of patients with metastatic non-small cell lung cancer who have EGFR exon 19 deletions or exon 21 L858R mutations.
Ramucirumab (Cyramza, Eli Lilly) is a fully human monoclonal antibody. Erlotinib (Tarceva, Genentech) is an EGFR tyrosine kinase inhibitor.
The FDA based the approval on results of the randomized phase 3 RELAY trial, which included 449 treatment-naive patients with metastatic NSCLC whose tumors had EGFR exon 19 deletion or exon 21 L858R mutations.
Researchers assigned patients 1:1 to erlotinib dosed at 150 mg daily plus either ramucirumab dosed at 10 mg/kg or placebo every 2 weeks. Treatment continued until disease progression or unacceptable toxicity.
Investigator-assessed PFS served as the primary endpoint.
Researchers reported significantly longer median PFS in the ramucirumab group (19.4 months vs. 12.4 months; HR = 0.59; 95% CI, 0.46-0.76).
Overall response rates were similar between the ramucirumab and placebo groups (76% vs. 75%), but mediation duration of response was longer in the ramucirumab group (18 months vs. 11 months).
OS data were not mature at the time of final PFS analysis, as only 26% of deaths required for the final analysis had occurred.
The most common adverse events reported among patients assigned the ramucirumab-erlotinib combination included infections, hypertension, stomatitis, proteinuria, alopecia, epistaxis and peripheral edema. The most common laboratory abnormalities included increased alanine aminotransferase, increased aspartate aminotransferase, anemia, thrombocytopenia, neutropenia, increased alkaline phosphatase and hypokalemia.