BridgeBio Oncology Therapeutics, Inc. (BBOT) announced new clinical data for its KRAS G12C inhibitor BBO-8520 and updated its corporate presentation on September 8, 2026. The company reported results from its ongoing Phase 1 ONKORAS-101 study (NCT06343402), focusing on non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations.
In the study, BBO-8520 was evaluated in combination with pembrolizumab in patients who had previously been treated with a KRAS G12C inhibitor. At the 500 mg once-daily dose level, the combination demonstrated an objective response rate (ORR) of 75%. Across all dose levels, the ORR was 53%.
Separately, BBO-8520 monotherapy was tested in patients who had not received prior KRAS G12C inhibitor treatment. The monotherapy showed an ORR of 63% (26 out of 41 patients) and a disease control rate (DCR) of 100%. Among 28 patients eligible for a six-month follow-up, 75% remained on treatment beyond six months. The safety profile was described as tolerable, with adverse events primarily gastrointestinal-related and no grade 3 liver enzyme elevations observed.
BridgeBio Oncology stated that it is focusing its capital on two strategic areas: BBO-8520 in combination with checkpoint inhibitors for patients with KRAS G12C inhibitor-experienced NSCLC, and combinations of BBO-11818 and BBO-10203 in KRAS-mutant colorectal cancer and pancreatic ductal adenocarcinoma.
As of June 30, 2026, the company reported having approximately $344.1 million in cash, cash equivalents, and marketable securities. BridgeBio Oncology projects this cash balance will fund operations into 2028. The company anticipates the following data catalysts over the next 12 months: updates on BBO-11818 and BBO-10203 monotherapy data in the fourth quarter of 2026, and expanded datasets for BBO-8520 plus pembrolizumab and combination cohorts in colorectal cancer and pancreatic ductal adenocarcinoma in mid-2027.
