Additional analysis of real-world data confirms sequential Gilotrif® followed by osimertinib provided a median overall survival of nearly four years in U.S.-treated patients with EGFR mutation-positive NSCLC

Ridgefield, Conn., August, 10, 2020 – Boehringer Ingelheim today announced a new analysis from the GioTag study, which showed that sequential Gilotrif® (afatinib) and osimertinib contributed to a median overall survival (OS) of nearly four years (47.6 months) among U.S. patients (129) with epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC) and the common resistance mutation, T790M. These findings are consistent with the global primary analysis of the GioTag study, as well as a separate, interim U.S. analysis.

GioTag is a real-world retrospective, observational study which assessed the impact of first-line treatment with afatinib followed by osimertinib in Del19/L858R EGFR M+ non-small cell lung cancer patients with acquired T790M mutations, the most common mechanism of resistance to first- and second-generation EGFR tyrosine kinase inhibitors (TKIs). This analysis looked at outcomes in the subgroup of patients (129) from the United States. Final analysis for the full GioTag patient population is expected to be published later this quarter.

“Developing resistance to EGFR TKIs is, unfortunately, an expected outcome for many people with this specific lung cancer, and strategies for sequencing treatments continue to evolve with the use of TKIs in clinical practice,” said Balazs Halmos, M.D., Chief of Thoracic/Head and Neck Oncology at Montefiore Medical Center. “These real-world data provide further insight into the overall survival associated with afatinib and subsequent osimertinib treatment and reinforce that previous findings may have application in the U.S. treatment setting for patients with T790M acquired resistance.” 

The afatinib-osimertinib sequence was associated with a combined median time on treatment (time to treatment failure; TTF) of 28.4 months overall. Similar TTF was also observed across several subgroups, including patients with EGFR Del19-positive disease (30.3 months), patients with ECOG PS 0/1 (32.7 months), and in patients ≥65 years of age (34.1 months).

In the most recent analysis, median time on afatinib was 11.3 months (90% CI: 10.3–12.0) and 15.0 months (90% CI: 13.4–16.4) for osimertinib.

Bjoern Rueter, M.D., Therapeutic Area Head Oncology, USA, at Boehringer Ingelheim, said, “These real-world data offer additional evidence that afatinib prior to osimertinib may be an important consideration for patients with EGFR mutation-positive non-small cell lung cancer. Cancer can take away so much, and understanding strategies such as treatment sequencing is one way Boehringer Ingelheim is taking cancer on.”

The U.S. data were sourced from chart review and electronic records of consecutive patients treated at U.S. treatment centers between December 28, 2017, to May 31, 2018. Previous interim analyses published in Future Oncology indicated that sequential afatinib and osimertinib was associated with encouraging time on treatment and overall survival in patients with EGFR T790M-positive NSCLC, particularly in patients with Del19 mutation.

More on the GioTag study can be found here.

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.

Please see Prescribing Information and Patient Information.

Important Safety Information

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 an ulcer, a tear (perforation) in your stomach or intestine, or diverticular disease (inflammation) in parts of your large intestine
• 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.
  • Females 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 during treatment with 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. Taking certain medicines with Gilotrif may increase your risk of developing a tear (perforation) in your stomach or intestine.

What to avoid while taking Gilotrif
Limit your time in the sun. Gilotrif can make your skin sensitive to sunlight. 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 if you have to be in sunlight during treatment with Gilotrif.

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.

• Tear (perforation) in your stomach or intestine. Tears in your stomach or intestine can happen with Gilotrif and can sometimes lead to death. Your risk of developing a tear in your stomach or intestine may be increased if you:
  • take certain medicines with Gilotrif including: corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDS), and certain other medicines.
  • have a history of stomach or intestinal ulcers, or if you have had diverticular disease (inflammation in parts of the large intestine)

Get medical help right away if you develop severe stomach-area (abdomen) pain during 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

Your doctor may change your dose, temporarily stop or permanently stop treatment with Gilotrif if you have certain side effects.

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

Gilotrif may cause decreased fertility in females and males. This may affect your ability to have a child. Talk to your doctor if this is a concern for you.

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.

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.
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life. 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.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.

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