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news.Boehringer Ingelheim has started a pivotal phase II trial of a drug that will work when other targeted therapies for lung cancer have failed.
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The company enrolled the first patients in the study of BI 1482694 (HM61713) in patients with non-small cell lung cancer (NSCLC) whose tumours test positive for the T790M mutation.
BI 1482694 is a novel, third-generation, oral, irreversible epidermal growth factor receptor (EGFR) mutant-specific tyrosine kinase inhibitor (TKI) developed to specifically target tumours with T790M mutations.
Boehringer Ingelheim said the T790M mutation is known as the most common resistance mechanism to develop in response to treatment with EGFR TKIs. It is identified in about 50% to 60% of patients who earlier received EGFR TKI therapy.
The company plans to achieve first market authorisation for BI 1482694 by 2017. The trial expands Boehringer Ingelheim’s position in EGFR mutated lung cancer with GIOTRIF/GILOTRIF (afatinib).
Boehringer Ingelheim medical head for solid tumour oncology Mehdi Shahidi said: "The addition of BI 1482694 to Boehringer Ingelheim’s lung cancer portfolio further underscores our commitment to patients with cancer.
"The initiation of the first pivotal trial of BI 1482694 is an important milestone in the forthcoming broad clinical trial programme, including several Phase III trials."
Earlier this year, Boehringer Ingelheim entered into an exclusive license and collaboration agreement with Hanmi Pharmaceutical for the development and global commercialisation rights of BI 1482694.