Doctors are hailing the results of “off the charts” studies that show a new drug has halted the progression of lung cancer longer than any other treatment in medical history.
Lung cancer is the leading cause of cancer death worldwide, accounting for about 1.8 million deaths each year. The survival rate for patients with advanced forms of the disease, where the tumors have spread, is particularly poor.
More than half of patients (60%) diagnosed with advanced lung cancer who took lorlatinib were still alive without progression five years later, data presented at the world’s largest cancer conference showed. The study found the rate was 8% in patients treated with the standard drug.
The results represent the longest progression-free survival (PFS) results ever recorded in patients with non-small cell lung cancer, the most common form of the disease worldwide. They were presented on Friday at the annual meeting of the American Society of Clinical Oncology (Asco) in Chicago.
“To our knowledge, 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 study, 296 patients with advanced non-small cell lung cancer were randomly assigned to receive either lorlatinib (149 patients) or crizotinib (147 patients, of whom 142 ultimately received treatment).
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. Lorlatinib and crizotinib are both ALK tyrosine kinase inhibitors (TKIs). ALK TKIs are targeted therapies that bind to the ALK protein found in ALK-positive non-small cell lung cancer and stop the growth of tumor cells.
“Despite significant progress with newer generation 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 shows a five-year progression-free survival, and after this time, most patients continue to have their disease under control, including control of the disease 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 the two drugs,” said Dr. Julie Gralow, Chief Medical Officer of Asco. “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, the world’s leading clinical trial facility specializing in new therapies for cancer patients, welcomed the findings. “These long-term data results are off the charts,” he said.
Most patients experienced some side effects. Treatment-related problems occurred in 77% of patients receiving lorlatinib and 57% of patients receiving crizotinib. The most common side effects reported in the Pfizer-funded study were swelling, high cholesterol and increased lipid levels.
Cancer Research UK’s chief clinician, Professor Charles Swanton, who was not involved in the study, said the “groundbreaking” results would provide new hope for patients with advanced lung cancer.
“Despite advances in our understanding of the disease, it can be incredibly challenging to control cancer that has spread, and treatment options for lung cancer are limited,” he said.
“This study, which shows the power of drugs to block the growth of cancer, could present us with an effective way to stop cancer in its tracks and prevent it from spreading to the brain.
“The ground-breaking results show that more than half of the patients who took lorlatinib did not suffer disease progression after five years. In contrast, more than half of the patients taking crizotinib had disease progression after just nine months.
“Research like this is crucial to finding new ways to treat lung cancer and help more people live longer.”