BerGenBio ASA, a clinical-stage biopharmaceutical firm, has released preliminary safety data from the Phase 1b segment of its BGBC016 study, focusing on first-line treatment for Non-Small Cell Lung Cancer (NSCLC) patients. The company, which specialises in developing novel, selective AXL kinase inhibitors, is investigating its drug bemcentinib in combination with standard chemo-immunotherapy (CIT).
The Phase 1b part of the study assessed three different escalating doses of bemcentinib in combination with doublet chemotherapy and pembrolizumab, better known as Keytruda®, for the treatment of advanced or metastatic NSCLC patients. The primary objective of this phase was to evaluate the safety profile of this combined treatment, irrespective of the patient’s STK11 mutational status.
Positive safety findings
The results revealed that all three selected doses of bemcentinib were well tolerated, with no new safety concerns identified during the study. These findings support the further clinical development of bemcentinib in combination with CIT for NSCLC patients. Notably, no dose-related effects on electrocardiographic changes (QTc), a recognised class effect of tyrosine kinase inhibitors, were observed for bemcentinib during the observation period.
The pharmacokinetic analyses—used to measure how the drug is absorbed, distributed, and excreted in the body—confirmed that the plasma levels of bemcentinib reached an adequate exposure, similar to levels seen in previous studies. The findings aligned with those from BerGenBio’s BGBC008 study, where bemcentinib, combined with pembrolizumab, was administered to second-line NSCLC patients and showed positive responses.
Encouraging news for ongoing trials
Martin Olin, Chief Executive Officer of BerGenBio, expressed optimism about the data, stating: “The results demonstrate that bemcentinib has a manageable safety profile, which boosts our confidence in continuing the BGBC016 clinical trial. The global trial is now moving into Phase 2a, targeting patients who have a mutation in the STK11 gene. We are excited to share the first preliminary data as it becomes available.”
This news is significant as the STK11 mutation is associated with poor prognosis in NSCLC patients, and identifying safe and effective treatments for this subset of patients has been challenging. The trial’s progression into Phase 2a reflects BerGenBio’s commitment to addressing unmet medical needs in cancer treatment.
Bemcentinib and its potential
Bemcentinib is a selective AXL kinase inhibitor, designed to block the AXL receptor tyrosine kinase, a protein that plays a crucial role in cancer cell survival, proliferation, and metastasis. The drug has shown potential in several clinical trials, particularly in lung cancer, and is seen as a promising candidate for combination therapies that enhance the effectiveness of standard cancer treatments.
The ongoing clinical trials are key to determining whether bemcentinib, when combined with existing treatments, can offer improved outcomes for patients with advanced NSCLC. As BerGenBio continues its research, the hope is that bemcentinib may offer a new option for patients with severe unmet medical needs in the field of oncology.
BerGenBio’s BGBC016 study is currently enrolling patients globally, and the company looks forward to further developments as the trial advances into the next phase. For more information, visit www.bergenbio.com
