Small-cell lung carcinoma with an unusual degree of cellular pelomorphism. Credit: Yale Rosen.

BerGenBio has dosed the first patient in the second part of the Phase II BGBC008 trial examining bemcentinib in combination with Keytruda (pembrolizumab) in patients with previously treated advanced adenocarcinoma of the lung (non-small cell lung cancer) whose disease is progressing.

The second part of BGBC008 intends to enrol 24 additional patients across sites in Norway, Spain, the UK and the US.

It is designed to validate the safety and clinical efficacy of the study’s drug combination.

Preliminary results from the trial are scheduled to be published next year.

The second part is based on positive results achieved in the trial’s first stage, which met its clinical efficacy endpoint.

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BerGenBio CEO Richard Godfrey said: “We recently reported positive data from this Phase II clinical trial at WCLC. Patients that were AXL positive reported a clinical response rate of 40%. Most notably, this included PD-L1 negative patients who do not benefit from Keytruda monotherapy.

“This data strengthens our confidence in bemcentinib’s mode of action, as well as the value of AXL inhibition to enhance patient outcomes to KEYTRUDA immunotherapy.”

“This data strengthens our confidence in bemcentinib’s mode of action, as well as the value of AXL inhibition to enhance patient outcomes to KEYTRUDA immunotherapy.

“Additional combination data in NSCLC, including bemcentinib with targeted and chemotherapy, also presented at WCLC provides further proof supporting the concept that AXL is a key player in mediating resistance to therapy and immune evasion, and that bemcentinib has the potential to become a cornerstone therapy in this challenging indication.”

BGBC008 is an open-label, single arm, multi-centre trial that aims to enrol up to 48 subjects.

The trial’s primary goal is objective response rate, while the primary goals include disease control rate, duration of response, overall survival, time to progression, and number of patients with adverse events.