NEW YORK – BerGenBio said on Tuesday it has partnered with Tempus for access to real-world clinical and molecular data to establish a synthetic control arm for its ongoing Phase Ib/IIa trial of AXL inhibitor bemcentinib in first-line non-small cell lung cancer patients with STK11 mutations.
The trial is evaluating bemcentinib in combination with the current standard-of-care treatment, Merck's immunotherapy Keytruda (pembrolizumab) and chemotherapy, in the first-line setting.
Under the collaboration with Tempus, Bergen, Norway-based BerGenBio will have access to a tailored cohort of Tempus' real-world clinical and molecular data to provide a contextual benchmark for the trial results. BerGenBio will also receive analyses to better understand the genomic landscape and therapeutic responses of NSCLC patients with STK11 mutations. Once the trial is concluded, BerGenBio and Tempus plan to present their results to regulatory agencies.
The bemcentinib plus PD-1 checkpoint inhibitor combination was granted fast track designation by the US Food and Drug Administration in 2021 for the treatment of STK11-mutant NSCLC. BerGenBio is also studying bemcentinib as a second-line treatment with Keytruda in NSCLC. In addition, the firm is developing another AXL inhibitor, mipasetamab uzoptirine, for solid tumors.