BerGenBio ASA, a clinical-stage biopharmaceutical company, has completed enrolment, ahead of schedule, of the planned 28 patients into the first stage of its phase II clinical trial evaluating its investigational oral selective AXL inhibitor bemcentinib (BGB324) in combination with the Merck & Co., Inc., Kenilworth, New Jersey, USA (known as MSD outside the United States and Canada) anti-PD-1 therapy Keytruda (pembrolizumab) as a potential new treatment regimen for advanced breast cancer.

The phase II trial (BGBC007) follows a two-stage design: it 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 designed to evaluate efficacy and safety of the combination, and to correlate the patient response with biomarker status (AXL kinase and PD-L1 expression). In parallel, 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.

The trial, which began in October 2017, is being conducted under a clinical collaboration with Merck & Co., Inc., Kenilworth, New Jersey, USA, through a subsidiary, and is taking place at more than 16 clinical sites in the US and Europe.

Richard Godfrey, chief executive officer of BerGenBio, commented: "We are delighted to have completed patient enrolment into the first part of this phase II trial in such a short time and ahead of schedule. Immuno-oncology therapies, such as Keytruda, are now established as a major treatment option for cancer patients and we are excited with the progress being seen across our clinical trials exploring if bemcentinib in combination with Keytruda can result in significantly improved patient outcomes. Positive results from these trials, and from our broader phase II development programme will help confirm the great potential we see for bemcentinib as a cornerstone therapy across multiple cancer indications and in combination with existing and emerging modalities of cancer treatment. We look forward to interim results from this and other studies during 2018."

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 in which it is being studied (advanced breast cancer, lung cancer and melanoma) with a safety profile similar to Keytruda  alone. Nineteen of the 34 patients evaluated in this analysis were from the BGBC007 breast cancer trial.

Breast cancer is the most common cancer in women – it is estimated that more than 250,000 new cases will be diagnosed in the US in 2018. 20% of breast cancers lack receptors for three common hormones (oestrogen, progesterone and HER2) and are thus called triple-negative breast cancers (TNBC). Treatment options for TNBC are limited to intense chemotherapy, but disease recurrence is frequent and aggressive. Consequently, novel treatment strategies for TNBC are urgently needed.

BerGenBio ASA is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors as a potential cornerstone of combination cancer therapy.