FDA Grants BBO-8520 Fast Track Status in KRAS G12C-Mutant NSCLC
BBO-8520, an investigational oral agent, has been granted fast track designation from the FDA in previously treated KRAS G12C–mutated metastatic non–small cell lung cancer.
- The FDA granted fast track designation to BBO-8520 in previously treated, KRAS G12C–mutated metastatic non–small cell lung cancer (NSCLC).
- The phase 1 ONKORAS-101 trial (NCT06343402) is currently evaluating BBO-8520 for the treatment of patients with KRAS G12C–mutant NSCLC.
- The study is assessing the safety, tolerability, and pharmacokinetics of BBO-8520.
The FDA has granted BBO-8520 fast track designation in adult patients with previously treated KRAS G12C–mutated metastatic NSCLC.1
BBO-8520 is an investigational oral agent currently undergoing evaluation in an open-label, multicenter, first-in-human, phase 1 study for the treatment of adult patients with pretreated KRAS G12C–mutated NSCLC and colorectal cancer (CRC).1,2
“Receiving fast track designation for BBO-8520 is a significant milestone in our efforts to overcome the limitations of existing therapies for KRAS G12C–mutant cancers,” said Yong Ben, MD, MBA, chief medical and development officer of BridgeBio Oncology Therapeutics, in a press release.1 “BBO-8520 represents a first-in-class approach with potential to address high unmet medical needs and shift the paradigm for cancer treatment. We will continue to work closely with the FDA to expedite the development of BBO-8520, which is currently being evaluated in a phase 1 study of [patients with] KRAS G12C[–mutant] NSCLC pretreated with first-generation KRAS G12C ‘OFF’ inhibitors or with no prior KRAS G12C–targeted therapy experience.”
Microscopic, photorealistic image of lung cancer cells - Generated with Adobe Firefly
The ONKORAS-101 trial includes patients with locally advanced or metastatic KRAS G12C–mutated NSCLC or CRC. Patients are being enrolled at 15 sites in the US and Australia.
Patients are required to have measurable disease by RECIST 1.1 criteria and an ECOG performance status of 0 or 1.2 In June 2024, it was announced that the first patient in the trial was dosed with BBO-8520.3
In the dose-escalation phase of the trial, patients will be given oral BBO-8520 daily at various dose levels. The therapy will be administered as monotherapy in cohort 1a and in combination with intravenous pembrolizumab (Keytruda) in cohort 1b. For the dose expansion phase of the study, patients will be given the assigned dose of BBO-8520 either as monotherapy (cohort 2a) or in combination with pembrolizumab (cohort 2b).
Adverse events and dose-limiting toxicities serve as the primary end points of the trial. Secondary end points of the study consist of progression-free survival per RECIST 1.1 criteria, duration of response per RECIST 1.1 criteria, overall survival, and pharmacokinetics.
The estimated primary study completion date is August 2027.
REFERENCES
BridgeBio Oncology Therapeutics (BBOT) granted U.S. FDA fast track designation for BBO-8520 for KRASG12C-mutated metastatic non-small cell lung cancer. News release. BridgeBio Oncology Therapeutics. January 9, 2025. Accessed January 13, 2025. https://tinyurl.com/3psc9ew7
Study of BBO-8520 in adult subjects with KRASG12C non-small cell lung and colorectal cancer. ClinicalTrials.gov. Updated October 30, 2024. Accessed January 13, 2025. https://clinicaltrials.gov/study/NCT06343402
BridgeBio Oncology Therapeutics announces first patient dosed with BBO-8520 in the ph. 1 ONKORAS-101 trial for KRASG12C NSCLC. BridgeBio Oncology Therapeutics. June 6, 2024. Accessed January 13, 2025. https://tinyurl.com/bdebt3vs
