Doctors are hailing “off-the-charts” trial results that show a new drug has halted the progression of lung cancer for longer than any other treatment in medical history.
Lung cancer is the leading cause of cancer death worldwide, accounting for approximately 1.8 million deaths each year. Survival rates for 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 took lorlatinib were still alive five years later without disease progression, data presented at the world’s largest conference showed for cancer. The rate was 8% in patients treated with the standard drug, the study found.
The results are the longest progression-free survival (PFS) 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 American Society of Clinical Oncology (Asco) annual meeting in Chicago on Friday.
“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 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 ultimately received treatment).
Just over half of the patients are 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 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 newer generation ALK TKIs, the majority of patients treated with second-generation ALK TKIs will have disease progression within three years,” Solomon said.
“Lorlatinib is the only ALK TKI to report five-year progression-free survival, and even after this period, most patients’ disease continues to be controlled, including disease control in the brain.”
The five-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 in non-small cell lung cancer is just unheard of.”
Dr David Spiegel, 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 off the chart,” he said.
Most of the patients experienced some side effects. Treatment-related problems occurred in 77% of lorlatinib patients and 57% of crizotinib patients. The most common side effects reported in the Pfizer-funded study 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 new hope for patients with advanced lung cancer.
“Despite advances in our understanding of the disease, it can be incredibly challenging to control cancers that have spread and there are limited options for lung cancer treatment,” he said.
“By demonstrating the power of drugs to block the growth of cancer, this study may provide us with an effective way to stop cancer and prevent it from spreading to the brain.”
“The ground-breaking results show that over half of the patients taking lorlatinib did not experience progression of their disease after five years. In contrast, more than half of the patients taking crizotinib had 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.”