FDA Approval of Brigatinib “Offers a New Hope” to Lung Cancer and Mesothelioma Patients

With mesothelioma patients undergoing a similar treatment protocol to lung cancer patients, the mesothelioma community sits up and takes notice any time a new chemotherapy drug for mesothelioma receives approval from the  U.S. Food and Drug Administration. Last week, the FDA announced approval of Brigatinib (Alunbrig) for ALK-positive non-small cell lung cancer patients who have progressed on or are intolerant to crizotinib. ALK is a primary biomarker for researchers hoping to find new, effective treatments for mesothelioma lung cancer and pleural mesothelioma patients.

The anaplastic lymphoma kinase (ALK) gene is just one of many protein kinases that function as drivers of a variety of forms of cancer, including lung cancer and pleural mesothelioma, an asbestos-caused cancer of the lining of the lungs. Many researchers have found that kinases are involved in the gradual transformation of normal tissue in the lining of the lung into malignant pleural mesothelioma after exposure to asbestos. According to researchers, less than seven percent of lung cancer patients are ALK-positive, and an unknown number of mesothelioma patients potentially express the abnormal ALK.

Approval was granted to the drug after a Phase 3 clinical trial resulted in a “clinically meaningful and durable overall response rate” in ALK-positive NSCLC patients, according to the FDA’s April 28 press release. Of the 222 patients in the trial, overall response rate was 48 percent in patients receiving a 90 mg dosage and 53 percent in patients receiving a 180 mg dosage. In an eight month follow-up, median duration of response for both groups was 13.8 months. The FDA recommends a 90 mg dosage for seven days, then an increase to 180 mg as tolerated.

“Today’s FDA approval of ALUNBRIG is an important milestone in the treatment of patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib,” said Christophe Bianchi, M.D., President, Takeda Oncology, maker of the drug, in an April 28 press release. “Takeda is committed to the continued development of ALUNBRIG around the globe and to bringing this important therapy to more patients in need.”

The ALTA clinical trial compared the efficacy and safety of Brigatinib to that of crizotinib in ALK-positive advanced lung cancer patients who had not yet been treated with any ALK inhibitors. 78 percent (in the 90 mg arm) and 68 percent (in the 180 mg arm) of the patients who were suffering from brain metastasis at the time of the trial were found to have maintained an intracranial response for at least four months.

Both lung cancer and pleural mesothelioma are aggressive cancers leading to metastasis in many patients. Last year, a study showed that crizotinib was more effective than chemotherapy in ALK-positive lung cancer patients who are battling brain cancer metastasis. However, since not all patients can tolerate crizotinib, finding a new drug that could be effective in that population of patients is critically important.

“For patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib, who are facing the uncertainty of disease progression and the potentially devastating impact of brain metastases, the approval of ALUNBRIG offers a new hope,” said Bonnie Addario, founder and chair of the Addario Lung Cancer Foundation (ALCF).

Nearly 3,000 Americans are diagnosed with pleural mesothelioma each year. Brigatinib is another step towards personalized cancer care that could benefit those battling mesothelioma. Personalized care targeted to a patient’s unique characteristics and genetic makeup, such as the ALK biomarker, optimizes the potential for success of the treatment.

To find out more about the ALTA clinical trial see ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?term=%22malignant+mesothelioma%22&recr=Open&pg=1

Sources:

• FDA announced approval of Brigatinib
  https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555841.htm
• Takeda Oncology
  https://www.takeda.com/newsroom/newsreleases/2017/alunbrig-fda-approval/
• FDA’s April 28 press release
  https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555841.htm