The FDA-approved lung cancer drug osimertinib (sold under the brand name Tagrisso) slashes the risk of death by 51% for certain patients whose cancer is caught early, according to new trial data.
“This should be the new standard of care for these patients,” Nathan Pennell, co-director of the Cleveland Clinic Lung Cancer Program, who wasn’t involved in the drug’s development, said in a statement for the American Society of Clinical Oncology.
The drug: Lung cancer is the second-most common cancer in the world, with 2.2 million new diagnoses every year. The vast majority fall into a category called “non-small cell lung cancers” (NSCLC), and of those, about a third of tumors have mutations in a particular gene, called EGFR.
Without proof it could extend overall survival, some doctors have been hesitant to prescribe osimertinib as an adjuvant therapy.
In 2017, the FDA approved a drug developed by AstraZeneca, osimertinib, to treat cancers with the mutation that had spread to other parts of the body.
Three years later, regulators also approved the lung cancer drug to treat NSCLC that was caught before it had spread and after doctors had surgically removed what cancer they could from the lungs.
The missing data: The 2020 approval was based on osimertinib’s ability to extend “disease-free survival” in a clinical trial. That means that, compared to people given a placebo, those who took the drug after surgery went longer without their cancer coming back or dying from other causes.
That didn’t prove the drug extended overall survival — the time between treatment and death from lung cancer — for those patients, though.
Without that proof, some doctors have been hesitant to prescribe osimertinib as an adjuvant therapy after surgery as it would mean burdening their patients with its risk of serious side effects and high price tag — the drug costs about $17,000 per month in the US, and patients are expected to take it as long as it keeps their cancer at bay.
“Adjuvant treatment with osimertinib provides patients with the best chance of long-term survival.”
Roy S. Herbst
What’s new? AstraZeneca has now reported that the lung cancer drug does have a huge impact on overall survival in that scenario: in a phase 3 trial, 88% of people treated with Tagrisso following surgery were still alive 5 years later compared to 78% of people given a placebo.
“Tagrisso cut the risk of death by more than half in the adjuvant setting, further establishing this transformative medicine as the backbone treatment for EGFR-mutated lung cancer,” said Susan Galbraith, AstraZeneca’s executive VP of Oncology R&D.
“These highly anticipated overall survival results … are a momentous achievement in the treatment of early-stage EGFR-mutated lung cancer,” added Roy S. Herbst, the trial’s principal investigator. “These data underscore that adjuvant treatment with osimertinib provides patients with the best chance of long-term survival.”
Looking ahead: The trial was relatively small, with fewer than 700 participants, and since osimertinib is already approved for use after surgery, the new results aren’t going to have any regulatory impact.
However, Dave Fredrickson, AstraZeneca’s executive VP of oncology, told Reuters he estimates that about 33% of patients who could benefit from the lung cancer drug aren’t receiving it — these results could encourage oncologists to prescribe the drug to those patients.
“We would hope that we would be able to use these data to be able to close that gap,” he said.
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