NEW YORK – Bayer on Thursday said it began a Phase III trial evaluating the EGFR and HER2 inhibitor BAY 2927088 as a first-line treatment for advanced non-small cell lung cancer patients whose tumors have activating HER2 mutations.
In the SOHO-02 trial, Bayer will enroll 278 patients and compare the activity of BAY 2927088 against standard-of-care treatment with Merck's checkpoint inhibitor Keytruda (pembrolizumab) plus platinum-based chemotherapy. The primary endpoint of the study is progression-free survival, determined by blinded, independent, central review. Researchers will also measure patients' response rates, duration of response, and adverse events on BAY 2927088 versus Keytruda-chemo.
BAY 2927088 was developed within a 2013 research collaboration between Bayer and the Broad Institute, a pact the partners extended for another five years last year. Earlier this year, the US Food and Drug Administration granted BAY 2927088 breakthrough therapy designation as a potential therapy for previously treated patients with unresectable or metastatic HER2-mutated NSCLC.
Bayer is also evaluating BAY 2927088 as a second- or later-line treatment for NSCLC patients with EGFR mutations and activating HER2 mutations in a Phase I/II trial.