Findings from the REVEL phase III study of patients with stage IV non -small cell lung cancer (NSCLC) indicate that a combination of a new anti-angiogenesis drug, ramucirumab, and standard docetaxel chemotherapy extends overall survival for patients who have a relapse after initial treatment compared to docetaxel plus placebo.

The median overall survival was 10.5 months in the ramucirumab arm compared to 9.1 months in the placebo arm.

“This is the first treatment in approximately a decade to improve the outcome of patients in the second-line setting,” said lead study author Maurice Pérol, MD, Head of Thoracic Oncology at Cancer Research Center of Lyon in France.

“The survival improvement is significant because patients with advanced NSCLC typically have a very short survival time following second-line therapy.”

Ramucirumab is a monoclonal antibody that specifically targets a protein called VEGF receptor 2, blocking growth of new blood vessels in the tumour (angiogenesis).

No other approved anti-angiogenesis drugs are available in the second-line setting for advanced NSCLC, and currently ramucirumab is approved only for advanced gastric cancer treatment.

There is a large unmet medical need in the second-line treatment of advanced NSCLC, as all patients eventually experience a relapse following initial therapy.

Approved second-line therapies for advanced NSCLC include docetaxel, erlotinib, and pemetrexed (for non-squamous NSCLC only), though clinical outcomes remain poor, with tumour shrinkage rates around 10 percent and median overall survival ranging between seven and nine months.

In the study, 1,253 patients with stage IV NSCLC (26 percent had the squamous subtype) that had progressed despite standard platinum-based therapy were randomly assigned to treatment with ramucirumab plus docetaxel or placebo plus docetaxel.

The addition of ramucirumab improved the efficacy of second-line docetaxel therapy–22.9 percent of patients experienced tumour shrinkage in the ramucirumab arm compared to 13.6 percent in the placebo arm.

The median overall and progression-free survival periods were 10.5 and 4.5 months in the ramucirumab plus docetaxel arm vs. 9.1 and 3 months in the placebo plus docetaxel arm, respectively.

The survival benefits were consistent in the major subgroups of patients, including squamous and non-squamous subtypes, suggesting that this therapy could be suitable for all major subtypes of NSCLC.

The safety profile was as expected for an anti-VEGFR agent in combination with docetaxel, with no increase in the rate of pulmonary haemorrhage (acute bleeding from the lung).

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Source: ASCO