Metastatic colorectal cancer treatment approved in the USA
Metastatic colorectal cancer treatment approved in the USA
27 Apr 2015The US FDA has approved ramucirumab for patients with metastatic colorectal cancer. The approval offers an important treatment option to patients, and it applies to disease which has progressed on a specific initial treatment (first line regimen containing bevacizumab, oxaliplatin and fluoropyrimidine.)
Clinical trial details
This approval is based on the results of a randomized, double-blind, multinational trial enrolling patients with metastatic colorectal cancer that progressed during or within 6 months of discontinuation of bevacizumab-, oxaliplatin- and fluoropyrimidine-based combination chemotherapy.
The clinical trial accrued 1072 patients who were randomly allocated to receive FOLFIRI plus placebo or FOLFIRI plus ramucirumab (536 per arm).
Treatment cycles on both arms were repeated every 2 weeks and ramucirumab was administered at a dose of 8 mg/kg by intravenous infusion every two weeks. Ramucirumab was continued until disease progression or unacceptable toxicity.
Treatment assignment was stratified by geographic region (North America vs. Europe vs. other regions), KRAS gene status (wild-type vs. mutant) and time to progression for the beginning of first-line treatment (< 6 months vs. greater than or equal to 6 months).
The median age of the study population was 62 years, 57% were men, and 99% had an ECOG performance status of 0 or 1.
Trial results: improved overall survival
A statistically significant overall survival improvement was observed in patients receiving FOLFIRI plus ramucirumab compared to those receiving FOLFIRI plus placebo.
Median overall survival was 13.3 and 11.7 months for patients on the FOLFIRI plus ramucirumab and FOLFIRI plus placebo arms, respectively.
Progression-free survival was also significantly improved in patients who received ramucirumab in combination with FOLFIRI. Median progression-free survival was 5.7 and 4.5 months, respectively.
Side effects
In general, the safety data was consistent with the known safety profile established in previously approved indications.
However, thyroid dysfunction (hypothyroidism) was reported in 2.6% of patients based on thyroid monitoring in patients with metastatic colorectal cancer.
Details about the drug
Ramucirumab is a drug medically described as "recombinant human monoclonal IgG1 antibody" that binds to the human vascular endothelial growth factor- receptor 2 (VEGF-R2), preventing its interaction of with its ligands.
The recommended dose and schedule in patients receiving ramucirumab in combination with FOLFIRI after progression on a first-line bevacizumab containing regimen is 8 mg/kg administered every 2 weeks as a 60-minute intravenous infusion.
Source: eCancer News