Doctors are hailing the results of a trial showing that a new drug stopped the progression of lung cancer longer than any other treatment in the history of the disease.
Lung cancer is the world’s leading cause of cancer death, causing approximately 1.8 million deaths each year. Survival rates are particularly poor for those with advanced forms of the disease, where the tumors have spread.
More than half of patients (60%) diagnosed with advanced forms of lung cancer who took lorlatinib were alive five years later without disease progression, data presented at the world’s largest cancer conference showed. The rate was 8% in patients treated with the standard drug, the trial found.
The results are the longest progression-free survival (PFS) outcomes ever recorded in patients with non-small cell lung cancer, the most common form of the disease in the world. They were presented Friday at the annual meeting of the American Society of Clinical Oncology (Asco) in Chicago.
“As far as we know, these results are unprecedented,” said the study’s lead author, Dr. Benjamin Solomon, a medical oncologist at the Peter MacCallum Cancer Center in Melbourne, Australia.
In a phase 3 trial, 296 patients with advanced non-small cell lung cancer were randomly assigned to either lorlatinib (149 patients) or crizotinib (147 patients, of whom 142 eventually received treatment).
Slightly more than half of the patients were women. In about 25% of them, the lung cancer had already spread to the brain when the study began.
All participants had ALK-positive non-small cell lung cancer. Both lorlatinib and crizotinib are ALK tyrosine kinase inhibitors (TKIs). ALK TKIs are targeted treatments that bind to the ALK protein found in ALK-positive non-small cell lung cancer and stop tumor cell growth.
“Despite significant progress with the newer generation of ALK TKIs, most patients treated with second-generation ALK TKIs will have disease progression within three years,” Solomon said.
“Lorlatinib is the only ALK TKI that has reported five-year progression-free survival, and even after that time, most patients still have their disease under control, including disease control in the brain.”
The 5-year progression-free survival (PFS) rate was 60% in patients receiving lorlatinib and 8% in the crizotinib group.
“You don’t need a magnifying glass to see the difference between these two drugs,” said Dr. Julie Gralow, Asco’s chief medical officer. “Sixty percent five-year progression-free survival for non-small cell lung cancer is simply unheard of.”
dr. David Spigel, chief scientific officer of the Sarah Cannon Research Institute in London, a world-leading clinical trial facility specializing in new therapies for cancer patients, welcomed the findings. “These long-term data results are out of the box,” he said.
Most patients experienced some side effects. Treatment-related problems occurred in 77% of patients on lorlatinib and in 57% of patients on crizotinib. The most common side effects reported in the Pfizer-funded trial were swelling, high cholesterol and elevated lipid levels.
Cancer Research UK’s chief clinician, prof. Charles Swanton, who was not involved in the study, said the “groundbreaking” results would offer fresh hope to patients with advanced lung cancer.
“Despite advances in our understanding of the disease, it can be incredibly difficult to control cancer that has spread and there are limited treatment options for lung cancer,” he said.
“By showing the power of drugs to block the growth of cancer, this study may present us with an effective way to stop cancer at its site and prevent it from spreading to the brain.
“Revolutionary results show that more than half of the patients who took lorlatinib did not have disease progression after five years. In contrast, more than half of patients taking crizotinib experienced disease progression after just nine months.
“Research like this is critical to finding new ways to treat lung cancer and help more people survive longer.”