The Food and Drug Administration (FDA) has approved Cyramza (ramucirumab; Lilly) in combination with erlotinib, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
The approval was based on data from the phase 3 RELAY study (N=449), which evaluated the efficacy and safety of ramucirumab in combination with erlotinib in previously untreated patients with metastatic EGFR-mutated NSCLC. Findings from the study showed that treatment with the combination resulted in a statistically significant improvement in median progression free survival (PFS; primary end point) compared with placebo plus erlotinib (19.4 months vs 12.4 months, respectively; HR 0.59; 95% CI, 0.46-0.79; P ≤.0001). The treatment effect for PFS was consistent across pre-specified stratification factors (exon 19 and exon 21 subgroups).
Additionally, overall response rate was 76% (95% CI, 71-82) in the combination arm and 75% (95% CI, 69-80) in the placebo plus erlotinib arm; median duration of response was 18.0 months (95% CI, 13.9-19.8) and 11.1 months (95% CI, 9.7-12.3), in each arm respectively. At the time of the final analysis of PFS, overall survival data were not mature as only 26% of planned events for the final analysis had occurred (HR=0.83; 95% CI, 0.53-1.30).
With regard to safety, the most common adverse reactions observed in patients treated with ramucirumab with erlotinib were, infections, hypertension, stomatitis, proteinuria, alopecia, epistaxis, increased alanine aminotransferase, increased aspartate aminotransferase, anemia, thrombocytopenia, and neutropenia.
“The approval of this new first-line metastatic EGFR-mutated non-small cell lung cancer regimen, which inhibits the VEGFR and EGFR pathways together, is an important milestone in the treatment of this disease,” said Edward Garon, MD, David Geffen School of Medicine, University of California, and North America lead investigator of the RELAY trial.
Cyramza is also indicated for the treatment of non-small cell lung cancer (in combination with docetaxel), gastric cancer, colorectal cancer, and hepatocellular carcinoma.
For more information visit lilly.com.