The Ministry of Food and Drug Safety (MFDS) South Korea, has approved olmutinib (BI 1482694 / HM61713) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, who had been previously treated with an EGFR tyrosine kinase inhibitor (TKI).

The approval represents a first for regulatory authorities in South Korea and is a major breakthrough for patients. The compound will be distributed in South Korea by Hanmi Pharmaceutical Co. Ltd under the name olmutinib.

This approval is based on the results of the phase I/II HM-EMSI-101 [NCT01588145 (link is external)] clinical trial which showed promising clinical activity for olmutinib (BI 1482694 / HM61713):  Among 69 patients evaluable for response, objective response was observed by independent assessment in 62% of patients, including 32 (46%) whose tumour response had been confirmed at the time of data cut-off, 30 June 2015; Disease control rate was 91% by independent assessment;  Majority of treatment-related adverse events (AEs) were mild-to-moderate and the most common included diarrhoea, nausea, rash and skin itching.

Professor Keunchil Park, Director of Innovative Cancer Medicine Institute (ICMI) at Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea commented, “The approval of olmutinib is a great step forward for lung cancer patients in South Korea. This is an exciting and much needed new treatment option for the majority of EGFR mutation-positive lung cancer patients whose disease has become resistant to first-line TKI therapy, which can be a devastating development.”

Olmutinib (BI 1482694 / HM61713) is a novel third-generation, oral, EGFR mutation-specific TKI. It is currently in accelerated development through the ambitious ELUXA clinical trial programme with the aim to submit data and evidence to the US FDA and EU EMA in 2016. The pivotal phase II trial ELUXA 1 (HM-EMSI-202 [NCT02485652 (link is external)]) is ongoing, enrolling EGFR T790M mutation-positive lung cancer patients who have become resistant to previous TKI treatment.

Dr Jörg Barth, corporate senior vice president, Therapy Area Head Oncology, Boehringer Ingelheim said, “This first approval of olmutinib is an exciting milestone for the compound and we are working diligently to make this novel treatment option globally available to patients and physicians as quickly as possible.”

Boehringer Ingelheim and Hanmi Pharmaceutical Co. Ltd signed an exclusive license agreement in 2015 providing the German pharmaceutical company with worldwide exclusive rights except in South Korea, China and Hong Kong. ZAI Lab has secured exclusive rights in China (including Hong Kong and Macau).

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.