Biopharmaceutical company BerGenBio ASA (OSE:BGBIO) said on Monday that it has admitted 28 patients under the planned first stage Phase II clinical trial of bemcentinib (BGB324) in combination with KEYTRUDA (pembrolizumab) for the treatment of advanced breast cancer, the most common cancer in women.

The company said the first stage of its Phase II clinical trial is evaluating its investigational oral selective AXL inhibitor bemcentinib (BGB324) in combination with the Merck & Co Inc's anti-PD-1 therapy KEYTRUDA (pembrolizumab) as a potential new treatment regimen for advanced breast cancer.

This Phase II trial (BGBC007) is an open label, multi-centre study of bemcentinib in combination with KEYTRUDA in patients with previously treated, locally advanced and unresectable or metastatic triple negative breast cancer (TNBC) or triple negative inflammatory breast cancer (TN-IBC). Up to 56 patients in total will be included in the study (NCT03184558). The trial is being conducted at more than 16 clinical sites in the US and Europe, added the company.

According to the company, the companion diagnostics using these biomarkers, and others, are being developed for the identification of patients predicted to be most suitable for treatment with the bemcentinib / KEYTRUDA combination. Interim results are expected mid-year 2018.

In conjunction, the preliminary safety data reported at the ASCO-SITC Clinical Immuno-Oncology Symposium (January 2018) found that the bemcentinib / KEYTRUDA combination was well tolerated in a sample of patients across three cancer indications (advanced breast cancer, lung cancer and melanoma) with a safety profile similar to KEYTRUDA alone. About 19 of the 34 patients evaluated in this analysis were from the BGBC007 breast cancer trial.