Doctors are hailing “off-the-charts” trial results that show a new drug stopped the progression of lung cancer longer than any other treatment in medical history.
Lung cancer is the world’s leading cause of cancer death, causing approximately 1.8 million deaths each year. Survival rates in those with advanced forms of the disease, where the tumors have spread, are particularly poor.
More than half of patients (60%) diagnosed with advanced forms of lung cancer who received lorlatinib were still alive five years later without any progression of their disease, data presented at the largest cancer conference showed in the world. The rate was 8% in patients treated with a standard drug, the trial found.
The results are the longest progression-free survival (PFS) results ever recorded in patients with non-small cell lung cancer, the most common form of the disease in the world. They were presented at the annual meeting of the American Society of Clinical Oncology (Asco) in Chicago on Friday.
“To our knowledge, these results are unprecedented,” said lead study author Dr Benjamin Solomon, a medical oncologist at the Peter MacCallum Cancer Center in Melbourne, Australia.
In the phase 3 trial, 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 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. Lorlatinib and crizotinib are both 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 advances with new-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 has reported five-year progression-free survival, and even after that time, most patients continue to have their disease controlled, including control of disease in the brain.”
The five-year progression-free survival (PFS) rate was 60% in patients who received 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 in 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 trials institution 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 issues occurred in 77% of lorlatinib patients and 57% of crizotinib patients. The most common side effects reported in the Pfizer-funded trial were swelling, high cholesterol and high lipid levels.
Cancer Research UK’s chief clinician, Prof Charles Swanton, who was not involved in the study, said the “groundbreaking” results would offer new hope for patients with advanced lung cancer.
“Despite progress in our understanding of the disease, it can be extremely challenging to control cancers that have spread, and there are limited treatment options for lung cancer,” he said.
“By showing the power of cancer growth-blocking drugs, this study may provide 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 over half of the patients who received lorlatinib did not experience progression of their disease after five years. In contrast, over half of the patients who received crizotinib experienced disease progression after just nine months.
“Research like this is vital to finding new ways to treat lung cancer and help more people survive longer.”
