Phase III trial shows lorlatinib highly effective against ALK-positive non–small cell lung cancer

A large team of medical researchers and doctors has found via phase III clinical trial that the ALK inhibitor lorlatinib is highly effective for treating non–small cell lung cancer (NSCLC).

In their paper published in the Journal of Clinical Oncology, the group describes the history of the drug and how well it has performed in treating cancer patients over five years of testing.

Prior research has shown that a protein called anaplastic lymphoma kinase (ALK) is responsible for controlling cell growth. It is produced by the body and directed by the ALK gene. Prior research has also shown that mutations to the ALK gene can result in the development of NSCLC, which is more common in younger people and is typically more aggressive than small-cell lung cancer.

Several years ago, researchers at Pfizer began working on the development of an ALK inhibitor, reasoning that such a drug would prevent the spread of NSCLC. That led to the development of a drug called lorlatinib, which is also known as Lorbrena.

Initial testing showed it to be effective against NSCLC, as expected. That has led to years of clinical trials, testing the efficacy of the drug and looking for any harm that it might cause. Thus far, as the researchers on this new effort note, the results have been unusually positive.

In the phase III trial, 296 patients with advanced NSCLC were given either lorlatinib or another drug called crizotinib, which is currently used to treat the disease. All of those involved in the study were monitored over the following five years.

The research team found that after five years, 60% of the patients who had received lorlatinib showed no signs of progression of their cancer—the highest of any drug to date. For those taking crizotinib, the rate was just 8%. They also found that the lung cancer had metastasized to the brain in only four of the patients given lorlatinib.

The research team found that a majority of those patients given lorlatinib did experience at least one adverse side-effect—the most common being an increase in cholesterol and lipid levels in the blood and swelling. They acknowledged that symptoms in some patients were so severe that they had to cease taking the drug for a short period of time and others had to stop taking it completely.

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