ASCO: Second-line treatment with ramucirumab with standard docetaxel extends survival in NSCLC

Ramucirumab (Cyramza) combined with docetaxel (Taxotere) extended overall survival 1.4 months in patients with non-small cell lung cancer (NSCLC) when compared to standard second-line therapy (docetaxel alone), according to data presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

Ramucirumab is a monoclonal antibody that specifically binds to the extracellular domain of VEGF receptor 2 on endothelial cells; therefore, it prevents the activation of the receptor by all VEGF ligands, which explains its anti-angiogenic activity, explained researcher Maurice Perol, MD, of Léon-Bérard Cancer Centre in Lyon, France.

The REVEL phase 3 study was designed to compare the efficacy and safety of ramucirumab given in combination with docetaxel against docetaxel plus placebo as second-line therapy. All tumor histologies, including squamous cell carcinoma, were included. The primary end point was to demonstrate a prolongation of overall survival (OS). There were 1,253 patients included in the study, among which 26% had squamous cell carcinoma.

REVEL met its primary end point, demonstrating the ability for ramucirumab to increase the efficacy of second-line chemotherapy with a significant prolongation of median OS (10.5 months for ramucirumab-docetaxel vs 9.1 months for placebo-docetaxel [HR= 0.86; P=.0235]). Addition of ramucirumab to docetaxel also improved median progression free survival (4.5 months for ramucirumab-docetaxel vs 3.0 months for placebo-docetaxel) and response rate (22.9% for ramucirumab-docetaxel vs 13.6% for placebo-docetaxel [P<.001]). The magnitude of the OS benefit was consistent in squamous and nonsquamous carcinoma, as well as across most subgroups of patients.

“The safety profile was quite good and similar to that of other VEGF inhibitors with a small increase in hematological toxicity of chemotherapy, a few clinically significant hypertension [5.4% of patients] but without increase in pulmonary hemorrhage or thrombo-embolic events,” said Dr Perol.

“The safety profile of the combination of ramucirumab to docetaxel was manageable with appropriate dose reductions and supportive care,” Dr Perol continued. “Ramucirumab did not have a negative impact on quality of life-although detailed analysis of QoL is still pending.”