Norway-based clinical-stage biopharmaceutical company BerGenBio ASA (OSE: BGBIO) announced on Monday that the independent Data and Safety Monitoring Board (DSMB) has confirmed the company's Phase 1b/2a BGBC016 study in Non-Small Lung Cancer (NSLC) to be acceptably safe at the highest dose tested in the study.

Due to this, the DSMB also recommended that no additional patients will be needed for Phase 1b under the study protocol.

The DSMB's recommendation enables the company to proceed as per study protocol and open the second dose level in the Phase 2a part of the study in NSCLC patients with STK11 mutations. This part of the study has already commenced enrolment and is aimed at assessing the efficacy of the combination of bemcentinib with pembrolizumab (Keytruda) and doublet chemotherapy.

The Phase 2a study is evaluating the safety and efficacy of two different doses of bemcentinib in the same treatment combination. The firm is expected to reveal an interim analysis in the second half of 2024.