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Resectable non-small cell lung cancer (NSCLC) has been traditionally treated with surgical removal of the tumor and, in some cases, chemotherapy following surgery. Yet among these resectable patients, though their cancer was diagnosed early enough to be eligible for surgery, and even when some received chemotherapy after surgery, nearly half diagnosed in Stage IB, and over three quarters of resectable Stage III patients had their cancer come back within five years.
Now, certain patients in this setting who test positive for an epidermal growth factor receptor (EGFR) mutation have the option of a targeted therapy to treat their NSCLC. Based on results from the ADAURA Phase III trial, the US Food and Drug Administration (FDA) recently approved TAGRISSO® (osimertinib) to treat adults with EGFR mutation-positive NSCLC to help prevent lung cancer from coming back after the tumor(s) has been removed by surgery. TAGRISSO is indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 L858R mutations as detected by an FDA-approved test. TAGRISSO is the first EGFR tyrosine kinase inhibitor (TKI) in a global, randomized, placebo-controlled trial to show a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in patients with Stage IB-IIIA EGFRm NSCLC after complete tumor removal compared to patients treated with placebo. In this trial, disease-free survival measured how long the patients in the clinical trial received treatment following surgery before their cancer came back or they died.
Until now, there were no approved targeted treatments for patients with resectable EGFRm NSCLC in the adjuvant setting.
“There remains a high rate of recurrence in patients with resectable NSCLC, even after tumor resection,” said Roy Herbst, MD, PhD, the principal investigator of the ADAURA trial and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital. “With the approval of TAGRISSO in the adjuvant setting (after surgery), we now have an EGFR TKI that has shown a disease-free survival benefit, which has the potential to change how we treat patients with resectable EGFRm NSCLC.”
Unprecedented disease-free survival data
In the primary endpoint of DFS in patients with Stage II and IIIA EGFRm NSCLC, the ADAURA trial showed that adjuvant treatment (after surgery) with TAGRISSO reduced the risk of the cancer coming back or death by 83% compared to patients treated with placebo. In the overall study population (Stage IB, II, and IIIA EGFRm NSCLC), TAGRISSO reduced the risk of the cancer coming back or death by 80% in a key secondary endpoint.
The safety and tolerability of TAGRISSO in the ADAURA trial were consistent with its established profile. In the ADAURA trial, the most common (>20%) adverse reactions were diarrhea, rash, nail toxicity, mouth sores, and dry skin.
EGFR mutation testing as a new focus of early-stage NSCLC
Biomarker testing for specific genetic mutations can help give oncologists more information about the genetic makeup of an individual’s tumor, allowing for more informed treatment decisions that may increase the likelihood of a patient’s type of lung cancer responding to the treatment.
“The approval of TAGRISSO in the adjuvant setting drives home the importance of biomarker testing for EGFR mutations earlier in the disease course to give physicians greater insight into what is driving the patient’s cancer for a more personalized treatment approach,” said Dr Herbst. “For those patients, with resectable NSCLC and have had their tumor removed by surgery, who test positive for EGFR mutations – one of the most common actionable mutations in NSCLC – the good news is that there is now a new treatment option in the adjuvant setting that can target that mutation.”
For more information on how targeted therapy and biomarker testing for EGFR mutations may help lead to the right treatment options for patients with resectable EGFRm NSCLC following surgery, visit here.
TAGRISSO Important Safety Information
TAGRISSO may cause serious side effects, including:
- lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever
- heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your healthcare provider should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your healthcare provider right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded
- eye problems. TAGRISSO may cause eye problems. Tell your healthcare provider right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO
- skin problems. TAGRISSO may cause skin problems. Tell your healthcare provider right away if you develop target lesions (skin reactions that look like rings), severe blistering or peeling of the skin
- inflammation of the blood vessels in your skin. TAGRISSO may cause blood vessel problems in your skin. Tell your healthcare provider right away if you develop purple spots or redness of the skin that does not fade in color when pressed (non-blanching) on your lower arms, lower legs, or buttocks or large hives on the main part of your body (trunk) that do not go away within 24 hours and look bruised
Before taking TAGRISSO, tell your healthcare provider about all of your medical conditions, including if you:
- have lung or breathing problems
- have heart problems, including a condition called long QTc syndrome
- have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
- have a history of eye problems
- are pregnant or plan to become pregnant. TAGRISSO can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with TAGRISSO or think you may be pregnant
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- Females who are able to become pregnant should have a pregnancy test before starting treatment with TAGRISSO. You should use effective birth control during treatment with TAGRISSO and for 6 weeks after the final dose of TAGRISSO
- Males who have female partners that are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 4 months after the final dose of TAGRISSO
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- are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during treatment with TAGRISSO and for 2 weeks after your final dose of TAGRISSO. Talk to your healthcare provider about the best way to feed your baby during this time
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your healthcare provider if you take a heart or blood pressure medicine
The most common side effects of TAGRISSO are:
- low white blood cell counts
- low platelet counts
- diarrhea
- low red blood cell counts (anemia)
- rash
- muscle, bone, or joint pain
- changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nail
- dry skin
- mouth sores
- tiredness
- cough
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of TAGRISSO. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is TAGRISSO?
TAGRISSO is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has certain abnormal epidermal growth factor receptor (EGFR) gene(s):
- to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery, or
- as your first treatment when your lung cancer has spread to other parts of the body (metastatic), or
- when your lung cancer has spread to other parts of the body (metastatic) and you have had previous treatment with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working
Your healthcare provider will perform a test to make sure that TAGRISSO is right for you.
It is not known if TAGRISSO is safe and effective in children.
Please see complete Prescribing Information, including Patient Information.
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US-43146 Last Updated 1/21