For the treatment of non-small cell lung cancer with Epidermal Growth Factor Receptor, exon 21 substitution, or exon 19 deletion mutations, the FDA has finally given approval to the combination of Erlotinib Tarceva and Ramucirumab on May 29th, 2020.
The efficacy of Ramucirumab and Erlotinib combination was established by conducting a randomized, multicenter, double-blind, placebo-controlled, multinational analysis (RELAY) in patients who were previously not treated for metastatic EGFR-positive type non-small cell lung cancer. A total of 449 patients participated in the test who were allocated to either receive 10mg/kg Ramucirumab arm or placebo arm as an intravenous infusion group for every two weeks. It was given in combination with Erlotinib 150 mg orally, once a day, until the body showed signs of unbearable toxicity or disorder advancement. The major endpoint of the study was the recorded progression-free survival (PFS) that had been evaluated by the investigator response evaluation criteria in solid tumors (RECIST v1.1). The additional efficacy endpoints were overall survival, the duration of response along with the overall response rate. While the median PFS recorded was 19.4 months for Erlotinib 150 mg and Ramucirumab group, it was 12.4 months for the placebo+ Erlotinib group. Similarly, the median duration of response for the Ramucirumab+ Erlotinib group and the placebo+ Erlotinib group was 18 months and 11.1 months, respectively. The adverse reactions that were observed were quite manageable and usual such as peripheral edema, hypertension, infections, epistaxis, alopecia, and stomatitis. The typical laboratory abnormalities were aspartate, elevated alkaline phosphatase, neutropenia, Hypokalemia, and anemia. The occurrence rate of adverse events was higher than the laboratory abnormalities in patients who were treated with Ramucirumab and Erlotinib than in patients who received the placebo+ Erlotinib treatment. All these instances were in favor of the fact that the combination of Ramucirumab and Erlotinib is an effective first-line treatment to cure metastatic NSCLC.
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