Lung Cancer Drug Gets Breakthrough Therapy Designation

The FDA on Monday granted Breakthrough Therapy Designation to a new treatment option for lung cancer.

The designation for the experimental third-generation epidermal growth factor receptor (EGFR) mutant-specific tyrosine kinase inhibitor (TKI) named BI 1482694 (HM61713) followed clinical trials evaluating the treatment of T790M mutation-positive non-small cell lung cancer (NSCLC) in patients whose tumors stopped responding to therapy.

“Boehringer Ingelheim is pleased that the FDA has granted Breakthrough Therapy Designation to our investigational third-generation EGFR inhibitor BI 1482694. We feel this designation reflects the potential of the compound to be an important part of the treatment of non-small cell lung cancer in patients with T790M mutation,” said Tarek Sahmoud, MD, PhD, vice president of Oncology Clinical Development and Medical Affairs at Boehringer Ingelheim. “The continued development of BI 1482694 and our entire oncology portfolio underscores our commitment to advancing novel treatment approaches designed to help improve the lives of people with cancer.”

BI 1482694 is an oral EGFR mutant-selective TKI that specifically targets tumors with T790M mutations, which is the most common resistance mechanism to EGFR TKI therapy. The mutation is found in approximately 50 to 60% of patients who received prior treatment with EGFR TKI.

Among these patients, treatment with BI 1482694 showed objective responses (ORs) of 62%, with a disease control rate of 91% in an independent assessment. The median duration of response had not yet been achieved at the time of data cut-off.

The most common adverse events associated with the treatment included (total/grade 3) diarrhea (55%/0%), nausea (37%/0%), rash (38%/5%) and skin itching (36%/1%).