Ramucirumab plus erlotinib receives FDA approval to treat metastatic NSCLC

On 29 May 2020, the combination of erlotinib and ramucirumab received Food and Drug Administration (FDA) acceptance for managing metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 21 (L858R) substitution or exon 19 deletion mutations.

A randomized, multicentre, double-blind, placebo-controlled, multinational analysis (RELAY) was performed to investigate the efficacy of ramucirumab plus erlotinib combination in individuals with previously untreated metastatic EGFR-mutated NSCLC.

Overall, 449 participants were allocated to either receive 10 mg/kg ramucirumab arm or placebo arm every two weeks as an intravenous infusion group, in combination with erlotinib 150 mg orally once daily, until unacceptable toxicity or disorder advancement.

Progression-free survival (PFS) as evaluated by the investigator Response evaluation criteria in solid tumors (RECIST v1.1) was the major endpoint of the study. Overall survival(OS), duration of response, and overall response rate (ORR) were the additional efficacy endpoints.

The median PFS, ORR, and the median duration of response for both groups are depicted in the following table:

Notably, OS information was not found to be mature at the time of the final PFS assessment because of the occurrence of only 26% of the mortality required for the final evaluation.

Peripheral edema, hypertension, infections, stomatitis, alopecia, proteinuria, and epistaxis were the most usual adverse reactions witnessed. Hypokalaemia, anemia, thrombocytopenia, neutropenia, and elevated alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase were the most usual laboratory abnormalities.

The incidence rate of adverse events and laboratory abnormalities was higher in individuals treated with ramucirumab with erlotinib when compared to individuals treated with placebo with erlotinib as shown in the following table:

For treating individuals with metastatic NSCLC, the effective dosage of ramucirumab in combination with erlotinib is found to be 10 mg/kg every two weeks. Thus, a combination of ramucirumab with erlotinib is an effective first-line treatment approach to cure metastatic NSCLC.

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