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‘Practice Changing’ Trial Results Suggest Tagrisso Can Delay Recurrence of EGFR Mutated Lung Cancer

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September 19, 2022

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Contributed by Abigail Seaberg, writer at SurvivorNet.


The drug Tagrisso is showing promise for lung cancer patients, yet again.

Updated results from the phase III ADAURA study presented at the European Society for Medical Oncology (ESMO) Congress 2022 showed that AstraZeneca’s drug osimertinib, brand name Tagrisso, demonstrated more exciting results for lung cancer patients with a mutation in the Epidermal Growth Factor Receptor (EGFR) gene. The study results further support the idea that this targeted drug, which is already approved for certain lung cancer patients with EGFR mutations, can bring precision medicine to patients with earlier, and thereby more curable, stages of lung cancer.

How Does This Drug Work For Lung Cancer Patients?

Before we get into the results of the ADAURA trial, let’s have a better understanding of how Tagrisso actually works. For starters, it’s important to remember that not all lung cancers are alike. Certain lung cancers have genetic mutations that help them grow and spread.

“If a lung tumor harbors an alteration of the EGFR gene, patients can respond to certain medications that block the function of the EGFR gene,” Dr. Balazs Halmos, director of the Multidisciplinary Thoracic Oncology Program at Montefiore Health Systems, explained to SurvivorNet. “Tagrisso is one of the very effective EGFR targeting agents used widely in cases of advanced/stage 4 EGFR-positive lung cancer.”

The EGFR gene mutation is present in about 10-15 percent of lung cancers in the United States and generally appears in the adenocarcinoma subtype of non-small cell lung cancer, according to the American Lung Association.

“It is an oral medication which binds EGFR primarily on lung cancer cells,” Dr. Salman Punekar, an oncologist at NYU Langone’s Perlmutter Cancer Center, told SurvivorNet of Tagrisso. “It blocks the ability of EGFR to support the survival and proliferation of these cancer cells.”

Side effects of the drug can include GI disturbance and skin changes, according to Dr. Punekar.

What Was The ADAURA Study?

Now, for the ADAURA study. Participants in this clinical trial were non–small-cell lung cancer (NSCLC) patients who had certain EGFR mutations and had their cancer surgically removed – meaning their cancers were at earlier stages where the cancer could  in fact, be removed.

These participants then either received Tagrisso or a placebo pill for up to three years so investigators could determine how long these patients could remain disease-free, which is referred to as disease-free survival, or DFS. Studying the DFS of this patient population being treated with Tagrisso is important because even though some people with earlier stage lung cancers may have their disease cured, recurrence is still common.

What Were The Results?

The DFS of the study’s participants who received Tagrisso was improved compared to those who received the placebo. A median DFS of nearly five and a half years (65.8 months) was seen in the overall population treated with Tagrisso versus 28.1 months with the placebo, and the risk of disease recurrence or death of the study’s participants was decreased by 73 percent in the overall trial population.

“In the overall study population, at 3 years, 85 percent of patients who received osimertinib [Tagrisso] were disease free (and alive) compared to 44 percent of patients who received placebo,” Dr. Punekar explained.

Additionally, less people in the Tagrisso group developed the cancer in their central nervous system (CNS) which is made up of the brain and spinal cord.

“There was a reduction in the risk of CNS disease of about 24% in patients who received osimertinib [Tagrisso],” Dr. Punekar told SurvivorNet. “This is significant because non–small-cell lung cancer (NSCLC) can travel to the brain, and when it does so, it is more difficult to treat. The fact that osimertinib had an effect here shows that the medication can enter the brain.”

What Do These Results Mean For People With Lung Cancer?

First off, it’s important to know that this study is part of an ongoing effort to evaluate the effectiveness of using Tagrisso in this subset of lung cancer patients.

“Osimertinib [Tagrisso] has shown efficacy in patients who have metastatic EGFR mutant NSCLC in the past,” Dr. Punekar explained. “This trial provides more evidence that it is effective even in patients who have had their EGFR mutant lung cancers surgically removed to reduce the risk of it coming back.”

Dr. similarly expressed the positive nature of this study’s results, but he also cautioned that we are still waiting to see how Tagrisso affects overall survival for these patients.

“Of course, side effects always have to be considered as well – fortunately, Tagrisso is generally quite safe and the quality of life in patients receiving Tagrisso did not seem adversely impacted,” Dr. Halmos told SurvivorNet. “So overall, this study is viewed as practice changing as even if overall survival is not impacted, delaying the recurrence of cancer by years is viewed as clinically impactful by most patients and providers and has therefore been approved by the FDA, however further data will be important to be able to fine tune our approach even better.”

What Should Lung Cancer Patients Ask Their Doctors?

This study highlights many important things for people with lung cancer to discuss with their doctor. First off, it shows just how important it can be to make sure you and your care team knows exactly what type of lung cancer you have.

“I believe the most important issue that patients should be asking their doctors is – has my tumor been tested in detail for biomarkers [such as an EGFR mutation] and have the biomarker tests helped define a precision medicine based approach?” Dr. Halmos explained. “Indeed, now we have a spectrum of tests and excellent treatment options for patients with advanced lung cancer, so we need to ensure each and every patient’s care is carefully tailored to help reach the best outcomes.”

“If the tumor tests positive for the EGFR biomarker – yes, it should be asked whether an EGFR targeting medicine, such as Tagrisso, might be the best approach for patients both with advanced and, thanks to the promising results of the ADAURA study, now also earlier stage disease.”