Olmutinib is a third-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI) intended to treat EGFR mutation-positive non-small cell lung cancer (NSCLC).
Boehringer Ingelheim will evaluate olmutinib as a monotherapy in various settings as well as in combination with investigational and established anti-cancer treatments, such as Merck’s anti-PD-1 therapy, pembrolizumab (Keytruda).
The Eluxa trial program complements the encouraging clinical data demonstrated in the phase I/II HM-EMSI-101 trial evaluating olmutinib in EGFR mutation-positive lung cancer patients who have become resistant to first-line TKI therapy.
The trial was the basis for breakthrough therapy designation granted by the US Food and Drug Administration in 2015 and the first approval to treat patients with T790M mutation-positive lung cancer in South Korea in 2016.
Accelerated trial program underway with Eluxa 1 trial fully enrolled and further phase III trials will start soon.
Boehringer Ingelheim solid tumor oncology medical head Mehdi Shahidi said: "The Eluxa trial program is designed to shed further light on our understanding of EGFR mutation-positive lung cancer to ultimately improve the outcomes for patients with high unmet medical need."