BerGenBio Launches Phase 2a Trial for STK11-mutated NSCLC Patients

Norwegian biopharmaceutical firm BerGenBio ASA has commenced the second phase of its BGBC016 clinical trial, which is focused on the treatment of Non-Small Cell Lung Cancer (NSCLC) patients with a specific genetic mutation known as STK11. The decision to advance to this stage of the trial was bolstered by a favorable endorsement from the independent Drug Safety Monitoring Board (DSMB), which had reviewed the safety profile of bemcentinib, BerGenBio's lead drug candidate, when combined with pembrolizumab and chemotherapy.

The STK11 mutation is associated with a notably reduced effectiveness of existing treatments, including immunotherapies, compared to patients without this mutation. AXL, a protein that significantly influences cancer cell survival and metastasis, is highly expressed in STK11 mutated NSCLC, indicating its potential as a key therapeutic target. Bemcentinib's ability to selectively inhibit AXL has demonstrated promising results in preclinical models and early clinical trials, improving the efficacy of immune checkpoint inhibitors.

Currently, there are no specific treatments available for patients with the STK11 mutation, a group that can constitute up to 20% of all first-line NSCLC patients. BerGenBio's Chief Medical Officer, Cristina Oliva, expressed satisfaction with the absence of new safety concerns and the DSMB's support to proceed with the trial. The company's CEO, Martin Olin, highlighted the significant medical need for new therapies in this patient population and the potential of bemcentinib to markedly improve patient outcomes.

BerGenBio is dedicated to developing innovative drugs that target the AXL pathway, which is implicated in aggressive diseases such as cancer and severe respiratory infections. The company, which is listed on the Oslo Stock Exchange, is headquartered in Bergen, Norway, and has a subsidiary in Oxford, UK. The initiation of the Phase 2a trial marks a crucial step in the validation process for bemcentinib as a novel treatment option in combination with standard care for first-line NSCLC patients with the STK11 mutation.