Promising efficacy and safety profile of olmutinib* (BI 1482694) is reaffirmed by further clinical data presented at ASCO 2016 annual meeting
Olmutinib is in accelerated development, with the now fully recruited pivotal Phase II ELUXA 1 trial ongoing and two Phase III trials initiating soon
(BUSINESS WIRE)-- Boehringer Ingelheim will announce updated results from the Phase II part of the HM-EMSI-101 [NCT01588145] trial at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, U.S. The study investigates the safety and efficacy of investigational olmutinib* (BI 1482694), a novel third-generation epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI) at the recommended dose of 800 mg once daily, in patients with EGFR T790M mutation-positive non-small cell lung cancer (NSCLC), who developed resistance to initial EGFR TKI therapy. Over half of patients (54%; n=38) had confirmed objective response by independent review, with a median duration of response of 8.3 months. These data validate previous top-line trial results presented at the European Society for Medical Oncology (ESMO) Asia Congress in December 2015.
Coordinating investigator Professor Keunchil Park, Division of Hematology & Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, South Korea commented, “These latest data further demonstrate the potential efficacy of investigational olmutinib for EGFR T790M mutation-positive lung cancer patients. We are building a robust bank of evidence for this compound and look forward to analysing the results of the pivotal Phase II trial.”
The results also indicate that the majority of olmutinib treatment-related adverse events (AEs) were mild-to-moderate with diarrhoea, nausea, rash and skin itching the most common.
Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim said, “The new analysis at 10 months after completion of enrolment, reaffirms that olmutinib has the potential to effectively treat patients who currently have few therapeutic options. We are committed to delivering the accelerated development of olmutinib through the ambitious ELUXA trial programme and we are looking forward to sharing further results later this year.”
Following promising early clinical data, Boehringer Ingelheim launched the innovative ELUXA Clinical Trial Programme to investigate olmutinib, a novel third-generation, EGFR mutant-specific TKI. The company will comprehensively investigate olmutinib as a monotherapy in different settings as well as in combination with other anti-cancer treatments. In recognition of the need for new treatment options for patients with EGFR T790M mutation-positive lung cancer, the U.S. Food and Drug Administration (FDA) granted olmutinib Breakthrough Therapy Designation in 2015.
*Olmutinib (BI 1482694) is approved in South Korea for the treatment of EGFR T790M mutation-positive lung cancer. Olmutinib is not approved in other indications and jurisdictions. Trials are ongoing and data will be submitted to other regulatory bodies in due course.
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