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Clinical trials are typically developed to show that a new or different treatment is more effective than the current standard of care, and a trial is usually considered successful if that is the end result. But a trial that doesn’t give those results isn’t necessarily a failure.
A recent trial reported in The New England Journal of Medicine showed that, overall, an immunotherapy drug was no better than chemotherapy for treating lung cancer, but this outcome only tells part of the story. When researchers looked at the results a little closer, the study actually makes a case for a more personalized approach to lung cancer treatment.
Immunotherapy has been useful for lung cancer
Immunotherapy stimulates the body’s immune system to fight cancer. Researchers have already had some success with immunotherapy for lung cancer, particularly when used after chemotherapy. They are now testing these drugs as the first treatment option after a diagnosis.
Nivolumab (Opdivo) is an immunotherapy drug currently approved by Health Canada to treat some cases of melanoma and kidney cancer, as well as lung cancer that has progressed after chemotherapy. Nivolumab is a checkpoint inhibitor that blocks an interaction between a protein on immune cells called PD-1 and a protein on cancer cells called PD-L1. Stopping the interaction between PD-1 and PD-L1 stimulates the immune system to attack cancer cells.
Clinical trial compared immunotherapy to chemotherapy
Researchers from Ohio State University led a clinical trial that tested nivolumab as a first-line treatment for non–small cell lung cancer. They recruited patients who had at least some measurable amount of PD-L1 protein in their cancer cells, though the amount of PD-L1 varied. Some patients only had a small amount and others had a lot. The patients received either nivolumab or standard chemotherapy as their first treatment after diagnosis.
When the researchers looked at the success of the treatments between the 2 groups, they found almost no difference in survival and response to treatment. Based only on these results, the new treatment didn’t seem to be better than the current one. But the researchers took a closer look.
Trial supports using tailored approach to immunotherapy
When the researchers broke down patients into subgroups based on characteristics of their cancer in an exploratory analysis, they found one particular subgroup who responded to nivolumab far more than the others.
People who had high amounts of PD-L1 protein in their tumours, along with a high number of genetic mutations in their tumours, benefited from immunotherapy more than other people. The researchers found that 75% of these patients responded to nivolumab, compared to only 16% of patients with low PD-L1 and a low number of tumour mutations. These results support that nivolumab may be an effective treatment for lung cancer, but that patients who receive it need to be selected carefully based on the characteristics of their tumours.
These results were somewhat unexpected, but they add to the case for a tailored approach to cancer treatment. The trial provides more evidence that new treatments that act on specific tumour features need to be used in a targeted way in order to be most effective.
Eileen Hoftyzer, BSc and Carolyn Goard, PhD