On July 25, 2016 Boehringer Ingelheim reported that it has decided to stop the global LUX-Head & Neck 2 trial (NCT01345669) as well as its Asian companion trial, LUX-Head & Neck 4 (NCT02131155) (Press release, Boehringer Ingelheim, JUL 25, 2016, View Source [SID:1234514053]). Both Phase III trials investigate afatinib in patients with locally advanced head and neck cancer who have no evidence of disease after treatment with chemotherapy and radiotherapy. Trial participants were randomly assigned to receive either afatinib or placebo (inactive drug) for up to 1½ years. It was hoped that afatinib, when given after chemo-radiotherapy, would prolong the disease-free/remission-free period of the head and neck cancer. Patients in LUX-Head & Neck 2 and 4 are being instructed by investigators to discontinue treatment, and further recruitment and/or randomization of patients has been halted. Health authorities and investigators have been informed. Schedule your 30 min Free 1stOncology Demo! During a pre-planned analysis, an independent Data Monitoring Committee (DMC) made the assessment that it would be highly unlikely that LUX-Head & Neck 2 will demonstrate a significant advantage in efficacy for patients treated with afatinib. The DMC therefore recommended to halt the trial and Boehringer Ingelheim has decided to discontinue it accordingly, as well as its companion trial LUX-Head & Neck 4. The DMC did not identify any major safety concerns in its assessment of the data, however it noted that there were more side effects on afatinib compared to placebo.
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The LUX-Head & Neck 3 trial investigating afatinib in Asian patients with recurrent and/or metastatic head and neck cancer will continue as planned, as recommended by the DMC during the same analysis. The positive results of its global pivotal trial LUX-Head & Neck 1 were presented in 2014. Results of LUX-Head & Neck 2 and 4 will be presented in the future.
The discontinuation of LUX-Head & Neck 2 and 4 in patients with locally advanced head and neck cancer does not affect afatinib (marketed in the U.S. under the brand name Gilotrif) as an approved treatment for patients with distinct types of EGFR mutation-positive non-small cell lung cancer (NSCLC) and advanced squamous cell carcinoma of the lung. Continued development of afatinib in other solid tumors is therefore not affected.
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.
or
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
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 the full Prescribing Information, including Patient Information.