New data are continuing to shape the approach that doctors and their patients take to diagnosing and treating lung cancer. Much of this research has centered around biomarkers, which offers a blueprint of what’s going on in a tumor, such as genetic mutations that might affect a patient’s prognosis and potential treatment options. Armed with this information — identified through biomarker and other diagnostic tests — clinicians can better match a patient to specific therapies, increasing the likelihood the patient may respond to treatment.
Previously, researchers presented progression free survival (PFS) data from the FLAURA trial. The results showed that TAGRISSO nearly doubled patients’ median PFS (18.9 months) — the study’s primary endpoint, which measures how long a person lives without the disease worsening — compared to first-generation EGFR-TKIs gefitinib or erlotinib (median PFS 10.2 months).
Results from the recent Phase III FLAURA trial demonstrated a median overall survival (OS) of more than three years in patients with metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC). The randomized trial investigated TAGRISSO® (osimertinib) as 1st-line treatment in adult patients with metastatic NSCLC with certain types of abnormal EGFR mutations against gefitinib or erlotinib. TAGRISSO delivered a median OS of 38.6 months vs 31.8 months for the comparator arm. TAGRISSO is a targeted therapy and third-generation EGFR-tyrosine kinase inhibitor (TKI).
A New Benchmark in Treating Metastatic EGFR mutation-positive NSCLC
New data for the trial’s secondary endpoint, OS, were presented at the recent European Society of Medical Oncology Congress. (OS measures how long a person lives from the time they are diagnosed.)
The results showed a statistically significant and clinically meaningful improvement in OS for TAGRISSO vs gefitinib or erlotinib in the 1st-line treatment of adult patients with metastatic NSCLC with certain types of abnormal EGFR genes. TAGRISSO provided a median OS of 38.6 months vs 31.8 months for gefitinib or erlotinib, previous standard-of-care treatments in this setting. This is the first time that a Phase III randomized trial in metastatic EGFR mutation-positive NSCLC patients treated with EGFR-TKIs demonstrated a statistically significant median OS of more than three years with first-line treatment.
In the FLAURA trial, the safety and tolerability of TAGRISSO was consistent with its established profile. The most common AEs (greater than/equal to 20%) in patients treated with TAGRISSO observed in the FLAURA trial were diarrhea (58%), rash (58%), dry skin (36%), nail toxicity (35%) stomatitis (29%), and decreased appetite (20%).
Groundbreaking Data in Treating Patients with Metastatic EGFR Mutation-Positive NSCLC
Metastatic lung cancer is a serious diagnosis that is often made once the disease has progressed through the blood or lymph system and formed a new tumor in other organs or tissues. More than 70% of lung cancer patients will first learn that they have the disease at this stage, when the prognosis is poor and limited treatment options are available. However, a biomarker-driven approach to treatment, as demonstrated in the FLAURA study, may give these patients a chance to live longer.
For more information on how biomarker testing can help lead to the right treatment options for patients with metastatic EGFR mutation-positive NSCLC, 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 doctor 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 doctor should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your doctor 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 doctor 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 doctor 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 doctor right away if you develop target lesions (skin reactions that look like rings), severe blistering or peeling of the skin
Before taking TAGRISSO, tell your doctor 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 doctor right away if you become pregnant during treatment with TAGRISSO or think you may be pregnant
- Females who are able to become pregnant 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
- 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 doctor about the best way to feed your baby during this time
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your doctor if you take a heart or blood pressure medicine
The most common side effects of TAGRISSO are:
- dry skin
- changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails
- mouth sores
- decreased appetite
Tell your doctor 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 doctor or pharmacist. Call your doctor 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 for non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic). TAGRISSO is used:
- as a first treatment if tumors have a certain abnormal epidermal growth factor receptor (EGFR) gene(s)
- if you have a certain type of EGFR gene and were previously treated with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working
Your doctor 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 full Prescribing Information, including Patient Information.
©2019 AstraZeneca. All rights reserved.
US-32579 Last Updated 12/19