Date: 2015-11-03
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Boehringer Ingelheim (Germany)
Product: BI 1482694 (HM61713)
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor. BI 1482694 (HM61713) is a novel 3rd generation, orally active, irreversible EGFR mutation selective tyrosine kinase inhibitor (TKI) developed to specifically target tumours with T790M mutations. The T790M mutation is known as the most common resistance mechanism to develop in response to treatment with EGFR TKIs. It is found in approximately 50-60% of patients who previously received EGFR TKI therapy. There are currently no EGFR-directed therapies approved specifically for the treatment of this mutation, representing an area of great unmet need for these patients. In July 2015, Hanmi Pharmaceutical and Boehringer Ingelheim announced an exclusive license and collaboration agreement for the development and commercialisation rights, except South Korea, China and Hong Kong, of HM61713
Disease: T790M mutation-positive non-small cell lung cancer (NSCLC), whose tumours stopped responding to currently available epidermal growth factor receptor (EGFR) directed therapies
Therapeutic area: Cancer - Oncology
Country: South Korea
Trial details:
Latest
news: * On November 3, 2015, Boehringer Ingelheim announced the initiation of a global Phase II trial evaluating the efficacy and safety of BI 1482694 (HM61713) in patients with T790M mutation-positive non-small cell lung cancer (NSCLC), whose tumours stopped responding to currently available epidermal growth factor receptor (EGFR) directed therapies. The aim is to achieve first market authorisation for BI 1482694, in this patient population, by 2017. The primary endpoint of this trial, which is the first in a broad clinical development programme for BI 1482694, is objective response rate (ORR). This trial is the first pivotal trial of BI 1482694.
