On May 17, 2016 Boehringer Ingelheim reported that Olmutinib* (BI 1482694 / HM61713) has been approved in South Korea 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) (Press release, Boehringer Ingelheim, MAY 17, 2016, View Source [SID:1234512496]). Schedule your 30 min Free 1stOncology Demo! 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.
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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):1
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).
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This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
Notes to editors
About olmutinib (BI 1482694)
Olmutinib (BI 1482694) is a novel third-generation, orally active, irreversible EGFR mutant-specific TKI. It is currently being investigated for the treatment of patients with advanced and metastatic EGFR mutation-positive NSCLC, whose tumours acquired T790M-mediated resistance to initial EGFR TKI treatment. The compound will be further investigated in the ELUXA pivotal trial programme which will include the initiation of Phase III studies in 2016. The trial programme will research the potential of the compound as a monotherapy and in combination with other potent treatments. Olmutinib (BI 1482694) has demonstrated promising clinical activity, combined with a favourable safety profile in a Phase I/II clinical trial (HM-EMSI-101).1
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