On November 9, 2021 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for bemcentinib in combination with an anti-PD-(L)1 agent as treatment for patients with STK11 altered advanced/metastatic NSCLC patients without actionable mutations (Press release, BerGenBio, NOV 9, 2021, View Source [SID1234594869]).
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Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need. It will enable BerGenBio to have more frequent interactions with the FDA throughout the drug development process so that an approved product can potentially reach the market faster.
In a separate release today 9 November 2021, BerGenBio announced that in pre-clinical NSCLC mouse models harboring STK11 mutations, sensitivity to PD-1 blockade was evaluated in the absence and presence of bemcentinib. Systemic inhibition of AXL with bemcentinib resulted in the expansion of tumor-associated T cells and restored therapeutic response to anti-PD-1 check point inhibition.
Further, data from BerGenBio’s Phase II bemcentinib and pembrolizumab combination study (BGBC008) in advanced NSCLC showed that 3 of 3 evaluable patients with identified STK11/LKB1 mutations demonstrated objective clinical response / clinical benefit to the combination of AXL inhibitor bemcentinib and pembrolizumab.
Martin Olin, Chief Executive Officer of BerGenBio, commented: "We are very pleased to receive Fast Track designation from the FDA for the second time this year and look forward to continuing to explore bemcentinib’s potential as a treatment option for NSCLC patients. It has been reported that patients habouring STK11 mutations represents up to 20% of the total NSCLC patient population, representing a large, identifiable subgroup of patients who may benefit from treatment with an AXL inhibitor such as bemcentinib."