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BerGenBio initiates Phase 1b/2a trial

Martin Olin

BerGenBio has announced the initiation of a trial evaluating bemcentinib in combination with the current standard of care, checkpoint inhibitor pembrolizumab and doublet chemotherapy, for the treatment of 1st line Non-Small Cell Lung Cancer patients harboring STK11 mutations.

“Real-world data continues to reinforce that the presence of STK11m currently result in particularly poor outcomes for NSCLC patients,” said Martin Olin, Chief Executive Officer of BerGenBio. “We believe that bemcentinib’s proficiency in blocking AXL overexpression may result in the reversal of an immunosuppressive tumor microenvironment leading to activation of immune response, restoration of sensitivity to immune checkpoint therapy and potentiation of chemotherapy effects in this large, underserved patient population.”

Bemcentinib

Bemcentinib, is a potent, first-in-class highly selective inhibitor of the receptor tyrosine kinase AXL, which is overexpressed in response to cellular stress, inflammation, hypoxia and chemotherapy. STK11 mutations are detected in approximately 20% of non-squamous NSCLC patients and are known to create a more immunosuppressive tumor microenvironment limiting the response to checkpoint inhibition. Preclinical data have demonstrated that by selectively blocking AXL activation, bemcentinib restores sensitivity to immune checkpoint inhibitor therapy, enhances chemotherapy, while also, pertinently, driving the expansion of CD8+ T cells in STK11m models. Early clinical data also point to the activity of bemcentinib in NSCLC patients, including those harboring STK11m.

The trial

The global, open-label Phase 1b/2a trial is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care in untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no actionable mutations. The Phase 1b portion of the study will evaluate the safety and feasibility of bemcentinib in combination with pembrolizumab and doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients, regardless of STK11 status. The Phase 2a expansion part will assess the efficacy of bemcentinib in the same treatment combination in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations. The first patient is expected to begin treatment in the fourth quarter of 2022.

Photo of Martin Olin: BerGenBio

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