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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Friday, January 17, 2025
The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to BBO-8520 for the treatment of adults with previously treated, KRAS G12C–mutated metastatic non–small cell lung cancer (NSCLC), according to its manufacturer BridgeBio Oncology Therapeutics. This investigational oral therapy targets this type of lung cancer by inhibiting both “on” and “off” states; thus, it reportedly provides optimal target coverage and addresses KRAS G12C amplification and receptor tyrosine kinase activation—two key mechanisms of adaptive resistance to current “off”-state inhibitors.
BBO-8520 is currently being evaluated in the phase I ONKORAS-101 trial (ClinicalTrials.gov identifier NCT06343402), focusing on patients with advanced KRAS G12C–mutant NSCLC and colorectal cancer. This first-in-human study is assessing the safety, tolerability, and pharmacokinetics of BBO-8520 as monotherapy or in combination with the PD-1 inhibitor pembrolizumab.
The discovery of BBO-8520 was the result of a collaboration between the National Cancer Institute RAS Initiative at Frederick National Laboratory for Cancer Research, Lawrence Livermore National Laboratory, and BridgeBio Oncology Therapeutics.
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