Real-world Study Shows Sequencing of Gilotrif® Followed by Osimertinib Delivered a Combined Median Time on Treatment of 27.6 Months in Patients with EGFR Mutation-positive NSCLC

- GioTag is the first global, real-world study to evaluate sequencing of targeted treatments in patients with EGFR mutation-positive NSCLC developing the most common acquired treatment resistance mutation

- Results published in the journal Future Oncology

RIDGEFIELD, Conn.  /PRNewswire/ -- Boehringer Ingelheim today announced results from GioTag, a real-world retrospective, observational study, which assessed total treatment duration of first-line Gilotrif^® (afatinib) followed by osimertinib in Del19/L858R epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC) patients with acquired T790M mutations, the most common mechanism of resistance to first- and second-generation EGFR tyrosine kinase inhibitors (TKIs). The results suggest that this sequential strategy may prolong the chemotherapy-free treatment period in the real-world patient population studied and were published in the journal Future Oncology.

"Real-world data, which is collected outside of a clinical trial environment from routine clinical practice, is increasingly being utilized to evaluate the use of cancer medicines," said Balazs Halmos, M.D., Chief of Thoracic/Head and Neck Oncology at Montefiore Medical Center.

According to the study, the median time on treatment for sequential afatinib and osimertinib was 27.6 months. In this broad, real-world population of 204 patients, the clinical results were consistent across all patient subgroups, with particularly encouraging results seen in those with exon 19 deletion (Del19)-positive disease (median time on treatment 30.3 months) and Asian patients (median time on treatment 46.7 months).

Among the patients included in this study, 15.2% had a poor performance status at the start of afatinib treatment (as defined by ECOG performance status ≥2), ordinarily precluding them from clinical trials.

Although not a primary objective of the study, and not mature at the time of analysis, the 2 year and 2.5 year overall survival (OS) rates were 78.9% and 68.8%, respectively.

"As additional treatment options for advanced lung cancer become available, it is important to understand the impact of multiple lines of targeted therapies on patient outcomes," said Dr. Halmos. "The results of GioTag suggest that sequential treatment with afatinib and osimertinib may be a viable approach and may offer a clinical benefit in patients with EGFR mutation-positive NSCLC."

Dr. Victoria Zazulina, Global Head of Solid Tumor Oncology, Medicine at Boehringer Ingelheim, said, "We saw through a recent global survey presented at WCLC that many physicians do not feel they have enough information to make informed treatment decisions on how to sequence treatments for patients with EGFR mutation-positive NSCLC, and in the absence of randomized data, real-world evidence may be helpful data. GioTag is the first global study to address the sequencing approach as it occurs in daily clinical practice. These real-world results may help inform physicians in their treatment approach for targeted therapies in NSCLC."

GioTag study results will be presented at an upcoming medical conference later this year.

What is Gilotrif?

Gilotrif is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC) that:

• has certain (non-resistant) abnormal epidermal growth factor receptor (EGFR) gene(s). Your healthcare provider will perform a test to make sure that Gilotrif is right for you.
• has spread to other parts of the body (metastatic), and
• has not been previously treated for metastatic lung cancer

It is not known if Gilotrif is safe and effective in treating people with lung cancer that has resistant abnormal EGFR genes.

or

is used to treat people with squamous cell lung cancer that:

• has spread to other parts of the body, and
• has been previously treated with chemotherapy that contains platinum.

It is not known if Gilotrif is safe and effective in children.

IMPORTANT SAFETY INFORMATION ABOUT GILOTRIF

Before you take Gilotrif, tell your doctor if you:

• have kidney or liver problems
• have lung or breathing problems other than lung cancer
• have a history of severe dry eye or any other eye problems. Tell your doctor if you wear contact lenses.
• have heart problems
• have any other medical conditions
• are pregnant or plan to become pregnant. Gilotrif can harm your unborn baby. You should not become pregnant while taking Gilotrif.
• Women who are able to become pregnant should use effective birth control during treatment with Gilotrif and for at least 2 weeks after your last dose of Gilotrif. Talk to your doctor about birth control methods that may be right for you.
• Tell your doctor right away if you become pregnant or think you are pregnant while taking Gilotrif.
• are breastfeeding or plan to breastfeed. It is not known if Gilotrif passes into your breast milk. Do not breastfeed while taking Gilotrif and for 2 weeks after your last dose of Gilotrif.  Talk to your doctor about the best way to feed your baby if you take Gilotrif.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.  Gilotrif may affect the way other medicines work, and other medicines may affect the way Gilotrif works.

What to avoid while taking Gilotrif

Limit your time in the sun. Gilotrif can make your skin sensitive to the sun. You could get or have worsening rash or acne. You could get a severe sunburn.  Use sunscreen and wear a hat and clothes that cover your skin while you are taking Gilotrif if you have to be in sunlight.

Gilotrif may cause serious side effects, including:

• Diarrhea. Diarrhea is common with Gilotrif and may sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with Gilotrif, your doctor should prescribe medicines to treat diarrhea. Take this medicine exactly as your doctor tells you to. Tell your doctor if you have diarrhea. Get medical attention right away if your diarrhea does not go away or becomes severe.
• Skin reactions. Gilotrif can cause redness, rash, and acne. It is important to get treatment for skin reactions as soon as you notice them. Take medicines to help skin reactions exactly as your doctor tells you to. Get medical attention right away if you develop severe skin reactions such as peeling or blistering of the skin, or blisters in your mouth.
• Lung or breathing problems. Gilotrif may cause inflammation of the lung that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung problems, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, or fever.
• Liver problems. Gilotrif can cause liver problems that can sometimes lead to death. Tell your doctor right away if you have any symptoms of a liver problem which may include:
• yellowing of your skin or the white part of your eyes (jaundice)
• dark or brown (tea-colored) urine
• pain on the upper right side of your stomach area (abdomen)
• bleeding or bruising more easily than normal
• feeling very tired

Your doctor will do blood tests to check your liver function during your treatment with Gilotrif.

• Eye problems. Tell your doctor right away if you have symptoms of eye problems. Symptoms may include:
• eye pain, swelling, redness, or tearing
• blurred vision
• sensitivity to light
• other changes in your vision
• Heart problems. Tell your doctor right away if you have any symptoms of a heart problem which may include:
• new or worsening shortness of breath while at rest or with activity
• cough
• tiredness
• swelling of your ankles, feet, or legs
• feeling that your heart is pounding or racing (palpitations)
• sudden weight gain

The most common side effects of Gilotrif include diarrhea, rash, mouth sores, nail inflammation, dry skin, acne, decreased appetite, nausea, vomiting, itching.

Gilotrif may cause decreased fertility in females and males.  Talk to your doctor if you have concerns about your fertility.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Gilotrif. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Prescribing Information and Patient Information.

About Boehringer Ingelheim in Oncology 
Cancer takes away loved ones, time and untapped potential. At Boehringer Ingelheim we are providing new hope for patients by taking cancer on. We are collaborating with the oncology community to deliver scientific breakthroughs to transform the lives of patients. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approaches to help combat many cancers.

About Boehringer Ingelheim Pharmaceuticals, Inc. 
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families.  Our employees create and engage in programs that strengthen our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about how we make more health through our Corporate Social Responsibility initiatives.

In 2017, Boehringer Ingelheim achieved net sales of about $20.4 billion (18.1 billion euros). R&D expenditure corresponds to approximately $3.4 billion (three billion euros), or 17.0 percent of its net sales.

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