Doctors are hailing ‘extraordinary’ research findings 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 world’s leading cause of cancer death and is responsible for approximately 1.8 million deaths per year. The chances of survival in people with advanced forms of the disease, where the tumors have spread, are particularly poor.
More than half of patients (60%) diagnosed with advanced lung cancer who took lorlatinib were still alive without progression of their disease five years later, data presented at the world’s largest cancer conference showed. The study found that this rate was 8% in patients treated with a standard drug.
The results are the longest progression-free survival (PFS) ever recorded in patients with non-small cell lung cancer, the world’s most common form of the disease. 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 the phase 3 study, 296 patients with advanced forms of non-small cell lung cancer were randomly assigned to treatment with lorlatinib (149 patients) or crizotinib (147 patients, of whom 142 were ultimately treated).
Just over half of the patients were women. In about 25% of them, the lung cancer had already spread to the brain when the study started.
The participants all 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 the growth of tumor cells.
“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 beyond this period, disease control remains in the majority of patients, including control of the disease in the brain.”
The five-year progression-free survival (PFS) rate was 60% in patients taking lorlatinib and 8% in the crizotinib group.
“You don’t need a magnifying glass to see the difference between these two medications,” 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 leading clinical research institute specializing in new therapies for cancer patients, welcomed the findings. “These longer-term results are off the chart,” he said.
Most patients experienced some side effects. Treatment-related problems occurred in 77% of patients taking lorlatinib and 57% of patients taking 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 medical officer, 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, controlling cancers that have spread can be incredibly challenging and there are limited treatment options for lung cancer,” he said.
“This study shows the power of drugs that block cancer growth and could give us an effective way to stop cancer and prevent it from spreading to the brain.
“The groundbreaking results show that more than half of patients taking lorlatinib showed no progression of their disease 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.”