麻豆传媒

CHICAGO -- An investigational targeted agent, combined with standard second-line chemotherapy, extended survival in patients with advanced non-small cell lung cancer (NSCLC), a researcher said here.

In a phase III randomized trial, ramucirumab (Cyramza) combined with docetaxel (Taxotere), also extended the time before the disease progressed, according to Maurice Perol, MD, of in Lyon, France.

It's the first time in a decade that a new drug has shown a survival benefit in second-line NSCLC, Perol said at the annual meeting of the American Society of Clinical Oncology.

But other experts were divided on its value, because the overall and progression-free survival benefits -- while statistically significant -- were small in absolute terms.

, of the Yale Cancer Center, said he is "pretty high on that drug," largely because he thinks the benefits are "quite extraordinary" compared with the risks.

"In second line, I find the data quite compelling," he added. "It is one of the top five important things in lung cancer this year."

On the other hand, , of the Massachusetts General Hospital Cancer Center in Boston, said the drug's benefits are probably not enough to get it through the regulatory process.

"I wouldn't use it if it were approved," he said, "but I don't think it can get approved on these data."

Ramucirumab is a recombinant human monoclonal antibody that blocks a receptor involved in building new blood vessels in tumors, thereby slowing their growth.

The REVEL trial tested the drug in combination with docetaxel, versus docetaxel alone, in 1,253 patients with stage IV NSCLC who had progressed either during or after previous treatment.

The top-line results were:

• A 1.4-month increase in median overall survival (OS), from 9.1 to 10.5 months, among patients on the combination therapy (hazard ratio 0.857 for death favoring the combination, P=0.023)
• A 1.5-month increase in median progression-free survival (PFS), from 3.0 to 4.5 months, for patients getting the two drugs (HR 0.762 for progression, P<0.0001)
• An increase in the objective response rate, from 14% for docetaxel alone to 23% with the combination (P<0.001)
• The most common grade 3 or great adverse events associated with the combination were neutropenia, febrile neutropenia, fatigue, leukopenia, hypertension, and pneumonia
• The rates of treatment-emergent adverse events that led to death were similar between the arms

But there is an ongoing debate over the value of new drugs, when the benefits are small and costs are likely to be high, commented of Memorial Sloan-Kettering Cancer Center in New York City.

"This trial is one of the more problematic ones," he told 麻豆传媒, because the improvements in OS and PFS were so small.

"We have to wonder, with the toxicity seen and the likely cost of the drug in addition to standard therapy, is it going to be worth it?" he said.

But he added, "we need more drugs and even drugs with a tiny benefit," noting that other drugs with small absolute benefits have been approved and are in use.

Indeed, the OS benefit was not "dramatically different" from what is seen in first-line therapy with bevacizumab (Avastin), according to

"If this drug were approved tomorrow," he told 麻豆传媒, "I would certainly look at it as an option for patients. Any kind of survival benefit is unique" in these patients.

"This represents an improvement in outcome," Lynch said.

The big question, he added, is whether it's possible to winnow out patients for whom the drug is highly beneficial.

"My suspicion is that, whether the FDA requires it or not, I think payers are going to increasingly ask that we use these drugs in patients who will benefit from them," Lynch said.

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