BerGenBio Selects 2nd Dose in Phase 2a STK11m Lung Cancer Trial

BerGenBio ASA, a clinical-stage biopharmaceutical company based in Bergen, Norway, has received a positive recommendation from the independent Data and Safety Monitoring Board (DSMB) regarding its ongoing BGBC016 clinical trial. This trial is exploring the safety and efficacy of bemcentinib, a selective AXL kinase inhibitor, in combination with pembrolizumab (Keytruda®) and doublet chemotherapy for patients with non-small cell lung cancer (NSCLC) harboring STK11 mutations.

The DSMB's assessment confirmed that the highest dose tested in the Phase 1b segment of the BGBC016 study was safe. Consequently, the board recommended that no additional patients are needed for this phase. This paves the way for BerGenBio to initiate the second dose level in Phase 2a of the trial.

Cristina Oliva, Chief Medical Officer at BerGenBio, expressed confidence in the safety profile of bemcentinib when paired with standard treatments for first-line NSCLC patients. She emphasized that opening the second dose level in Phase 2a will allow for a thorough evaluation of the dose response to bemcentinib, a critical aspect for optimizing doses in future trials.

Martin Olin, Chief Executive Officer of BerGenBio, highlighted that the BGBC016 trial remains the company's top priority. He noted the severe prognosis for NSCLC patients with STK11 mutations, who currently lack targeted therapy options. This patient group faces significant medical challenges but also presents considerable commercial opportunities.

The Phase 2a part of the trial aims to assess the safety and efficacy of two different doses of bemcentinib in combination with pembrolizumab and doublet chemotherapy. The company plans to present interim results from the study in the latter half of this year.

STK11 mutations in NSCLC patients are associated with poor responses to current treatments, including immune checkpoint inhibitors. These patients exhibit high levels of AXL expression, making AXL a crucial target for preventing disease progression and resistance to existing therapies. Bemcentinib's selective inhibition of AXL has been shown to enhance responses to immune checkpoint inhibitors in preclinical models and early clinical trials involving STK11m patients. Currently, there are no targeted therapies available for this subgroup, which constitutes up to 20% of first-line NSCLC patients.

BerGenBio ASA specializes in developing innovative drugs targeting AXL, particularly for severe diseases like cancer and serious respiratory infections. The company's lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor focused on treating STK11 mutated NSCLC and severe respiratory infections. With its headquarters in Bergen, Norway, and a subsidiary in Oxford, UK, BerGenBio is listed on the Oslo Stock Exchange under the ticker BGBIO.