Updated real-world data show Gilotrif® followed by osimertinib provided a median overall survival of up to almost four years in patients with EGFR Del19 and T790M mutation-positive NSCLC

Ridgefield, Conn., August 5, 2019 – Boehringer Ingelheim today announced updated, interim analysis results from the GioTag study, showing that initiating treatment with afatinib followed by osimertinib provided an overall survival (OS) of almost four years (45.7 months) in patients with Del19-positive tumors. GioTag is a real-world retrospective, observational and unblinded study which examined the impact of treatment with 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).

“It’s important to consider sequencing of therapies to provide patients with as many future treatment options given that many of them with this type of lung cancer eventually acquire resistance to EGFR TKIs,” said Balazs Halmos, M.D., Chief of Thoracic/Head and Neck Oncology at Montefiore Medical Center.

The GioTag study previously provided only 2 years and 2.5 years OS rates. Now, an interim analysis assessed updated data from a sub-set of patients (94/126) with available electronic health records (all from the U.S). The use of electronic data, which facilitated rapid analysis, represented the first step of a two-stage process. After a median follow-up of 30.3 months, median overall survival was almost three and a half years (41.3 months) in patients with acquired EGFR T790M-positive NSCLC treated in a real-world clinical setting, and the updated two-year OS rate was 80%.

OS is particularly promising in patients with Del19-positive tumors at the onset of afatinib treatment. In these patients, median OS was 45.7 months and the two-year OS rate was 82%.

Updated median time on treatment for sequential afatinib and osimertinib was 28.1 months overall, and 30.6 months in patients with Del19-positive tumors. Median time on osimertinib treatment following treatment with afatinib was 15.6 months and 16.4 month for Del19 mutations.

“Real-world data continue to inform the use and sequencing of cancer treatments,” said Dr. Halmos. “The updated GioTag study findings add to a growing body of evidence that afatinib followed by osimertinib is a viable treatment sequence and associated with prolonged overall survival for patients.”

Dr. Victoria Zazulina, Corporate Vice President and Global Head of Oncology, Medicine, at Boehringer Ingelheim, said, “The continued clinical development of new EGFR TKIs provides additional treatment options for patients with EGFR M+ NSCLC, and raises questions about their optimal sequence. Given that, as yet, no established targeted treatment options are available following failure of osimertinib, there is an argument for reserving osimertinib for second-line use after second-generation EGFR TKIs. Real-world data from the GioTag study supports the argument for sequential use of afatinib and osimertinib for patients with EGFR M+ NSCLC who are Del19-positive.”

The observational GioTag study provides data on a broad, real-world population of patients. 15.3% had a poor performance status of ECOG PS of ≥2 and 10.3% had stable brain metastases, ordinarily criteria which would preclude these patients from participation in clinical trials. This interim analysis is the first of a two-step process. A final analysis is planned for early 2020 which will include updated data from Asian and European countries.

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. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hope by taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science. 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 our goal is to improve the lives of humans and animals through its three business areas: human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim concentrates on developing innovative therapies that can improve and extend patients’ lives. As a research-driven pharmaceutical company, it plans in generations for long-term success. Its research efforts are focused on diseases with high, unmet medical need. In animal health, the company stands for advanced prevention.

In 2018, Boehringer Ingelheim achieved net sales of around $20.7 billion (17.5 billion euros). R&D expenditure of almost $3.7 billion (3.2 billion euros) corresponded to 18.1 per cent of net sales.

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