RIDGEFIELD, Conn., Sept. 8, 2016 /PRNewswire/ -- Results from a new post-hoc analysis of two large Phase III trials (LUX-Lung 3 and LUX-Lung 6) assessing the impact of dose adjustments for Gilotrif® (afatinib) in patients with advanced non-small cell lung cancer (NSCLC) were published today in Annals of Oncology. The analysis suggests specific dose reductions, as described in the prescribing information, led to decreases in the incidence and severity of treatment-related adverse events (AEs) in afatinib-treated patients without any apparent compromise in efficacy.
"Afatinib's efficacy and safety profile in the first-line treatment of patients with EGFR mutation-positive NSCLC has been well established in multiple large trials. This further analysis suggests that dosing of afatinib can be adjusted to help manage a patient's treatment-related adverse events, without any apparent reduction in efficacy. This may provide physicians and their patients with confidence and allows physicians to help address adverse events," commented principal investigator and lead author James Chih-Hsin Yang, Director, Department of Oncology, National Taiwan University Hospital, and Director, Graduate Institute of Oncology, National Taiwan University Cancer Center, Taiwan.
Afatinib-treated patients from the LUX-Lung 3 [NCT00949650] (n=229) and LUX-Lung 6 [NCT01121393] (n=239) trials were included in the analysis. Dose reductions took place in 53.3% (n=122) and 28% (n=67) of patients in each study, respectively, most within the first six months of treatment. Dose reductions were associated with decreases in the incidence and severity of treatment-related AEs, while median progression-free survival (PFS) was similar in patients who dose-reduced within the first six months of treatment versus those who did not (LUX-Lung 3, 11.3 vs 11 months; LUX-Lung 6, 12.3 vs 11 months).
Mehdi Shahidi, M.D., Global Head of Medicine, Oncology, Boehringer Ingelheim, said, "Afatinib has demonstrated significant treatment benefits compared to chemotherapy in the LUX-Lung 3 and 6 trials. These additional data on dose modification add to the robust body of evidence for afatinib. Adjusting the dose where needed provides healthcare professionals with increased flexibility in the appropriate use of afatinib."
LUX-Lung 3 and LUX-Lung 6 are multicenter, randomized, open-label, Phase III trials of afatinib versus chemotherapy (pemetrexed / cisplatin and gemcitabine / cisplatin, respectively) as first-line treatment for patients with EGFR mutation-positive, advanced and metastatic NSCLC. Both trials met their primary endpoint of PFS with afatinib significantly delaying tumor growth when compared to standard chemotherapy. In addition, afatinib is the first treatment to have shown an overall survival (OS) benefit for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy.
Afatinib is approved in over 70 countries for the first-line treatment of EGFR mutation-positive NSCLC. Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial. Afatinib should be initiated at the approved dose of 40 mg/day; tolerability-guided dose adjustments can then be made to reduce afatinib-related AEs without an apparent impact on therapeutic efficacy.
What is GILOTRIF?
GILOTRIF is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC):
- that has certain types of abnormal epidermal growth factor receptor (EGFR) genes. Your doctor will perform a test to check for certain types of abnormal EGFR genes, and make sure that GILOTRIF is right for you. GILOTRIF may be used when you have not had previous treatment for cancer that has spread to other parts of the body. It is not known if GILOTRIF is safe and effective in treating lung cancer with other abnormal EGFR genes.
- that is squamous type and has spread to other parts of the body after you have tried 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
- 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 the full Prescribing Information, including Patient Information.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
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. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.
In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.
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SOURCE Boehringer Ingelheim Pharmaceuticals