The Lynx Group

Ramucirumab Improves Survival in Patients with Lung Cancer

August 2014, Vol 5, No 6

Chicago, IL—When added to chemotherapy (ie, docetaxel), the new monoclonal antibody ramucirumab improved overall survival (OS) compared with chemotherapy alone in patients with stage IV non–small-cell lung cancer (NSCLC), according to phase 3 trial results presented at the 2014 American Society of Clinical Oncology meeting. The results were presented by Maurice Pérol, MD, of the Département de Cancérologie Médicale, Centre Léon-Bérard, Lyon, France.

“This is the first treatment to have shown a significant survival advantage over chemotherapy alone in second-line therapy of NSCLC, and the first treatment in approximately a decade to improve outcomes in the second-line setting,” said Dr Pérol.

Ramucirumab was recently approved by the FDA for the treatment of patients with advanced gastric cancer; it targets vascular EGFR2, which blocks the formation of new blood in the tumor.

“This study met the primary end point of OS, reducing the risk of death by 14% and prolonging median survival by 1.4 months,” said Dr Pérol. Furthermore, the combination of ramucirumab plus chemotherapy reduced the risk of disease progression by 24%.

“Ramucirumab represents a potential new option for treatment in the second-line setting,” Dr Pérol suggested.

If approved by the FDA for NSCLC, ramucirumab would be the first antiangiogenic drug approved for the second-line treatment of patients with this type of cancer.

Survival improvement was seen in patients with squamous and with nonsquamous histology; the median OS benefit was significant but modest.

Dr Pérol said that the drug could be useful in patients lacking a specific mutation, such as EGFR or ALK, that would make them candidates for targeted therapy.

Study Details
The double-blind, placebo-controlled, phase 3 REVEL clinical trial included 1253 patients with stage IV NSCLC (26% of whom had squamous histology) whose disease progressed with standard platinum-based therapy. Patients were randomized to ramucirumab plus docetaxel or to docetaxel plus placebo.

The active combination significantly improved response rate, progression-free survival (PFS), and OS compared with docetaxel alone. The median PFS times were 4.5 months with ramucirumab versus 3 months without (P <.001), and the median OS times were 10.5 months versus 9.1 months (P = .023), respectively.

The safety profile was similar to other angiogenesis inhibitors. No increase in pulmonary hemorrhage was reported with the combination.

Commenting on the study, Gregory A. Masters, MD, Director, Medical Oncology Fellowship, Helen F. Graham Cancer Center, Newark, DE, said, “This combination shows good activity in the difficult-to-treat second-line setting of NSCLC.”

Dr Masters noted that ramucirumab may be a small step along the pathway that will ultimately constitute improvement. “Progress is slow and step-wise, and we build one step at a time. The cumulative progress is what we find encouraging….A study like REVEL may not change the way we treat NSCLC, but it can influence our design of further studies,” he said. He added that the key to assessing the value of a drug is to “balance benefit with cost, and figure out how best to treat patients.”

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