On September 8, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported new clinical data for KRASG12C inhibitor BBO-8520 and the strategic prioritization of (i) BBO-8520 in combination with checkpoint inhibitor in 2L+ KRASG12C inhibitor-experienced non-small cell lung cancer (NSCLC) patients and (ii) BBO-11818 and BBO-10203 combinations in KRAS-mutant cancers.

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"Across our portfolio, all three programs have now generated encouraging clinical data supporting further development, enabling us to focus our capital on the opportunities with the highest probability of success, clearest development paths, and greatest potential patient benefit," said Pedro J. Beltran, Ph.D., Chief Executive Officer of BBOT. "With a strong balance sheet and multiple data catalysts through mid-2027, we believe BBOT is well positioned to advance differentiated therapies for patients with KRAS-driven cancers."

BBO-8520 (Direct KRASG12C ON/OFF Inhibitor) Key Findings:

BBO-8520 is an oral, direct KRASG12C(ON/OFF) inhibitor. By directly inhibiting both the ON and OFF states of KRASG12C, BBO-8520 is designed to achieve potent pathway inhibition at lower free-drug exposures and enable combination with checkpoint inhibition. In the ongoing ONKORAS-101 (NCT06343402) Phase 1 study (data cutoff: June 1, 2026):

BBO-8520 in combination with pembrolizumab in NSCLC KRASG12C inhibitor-experienced patients showed:

Objective response rate (ORR): 75% at the 500 mg once-daily (QD) dose level and 53% across all dose levels (N=17).
Generally tolerable and manageable safety profile. Adverse events were primarily gastrointestinal (GI)-related, and a favorable liver safety profile was observed.

BBO-8520 monotherapy in 2L+ NSCLC KRASG12C inhibitor-naïve patients showed:

ORR: 63% (26/41), with a disease control rate (DCR) of 100% (41/41).
Among 28 patients eligible for a six-month follow-up, 75% (21/28) remained on treatment beyond six months.
Tolerable and manageable safety profile with no grade 3 liver enzyme elevations.

"The encouraging efficacy and safety profile with BBO-8520 plus pembrolizumab supports development in patients with KRASG12C-mutant NSCLC who have progressed on a prior G12C inhibitor, a growing population with significant unmet need," said Yong (Ben) Ben, M.D., Chief Medical and Development Officer of BBOT.

Approximately 21,000 patients are expected to be diagnosed with NSCLC harboring KRAS G12C mutations in the United States in 2026. As G12C OFF-state inhibitors potentially move into the first-line setting, BBOT expects a growing population of patients who progress following treatment with a G12C inhibitor and for whom there is currently no approved targeted therapy.

Strategic Prioritization:

BBOT is focusing its capital and resources on opportunities that offer the highest probability of success and greatest potential benefit for patients:

BBO-8520 in combination with pembrolizumab in 2L+, KRASG12C inhibitor-experienced NSCLC patients.
BBO-11818 and BBO-10203 internal combination and independent combinations with standard of care agents in KRAS-mutant cancers.

Financial Position and Upcoming Milestones

As of June 30, 2026, BBOT had approximately $344.1 million in cash, cash equivalents and marketable securities which BBOT projects will fund operations into 2028. BBOT expects the following data catalysts over the next 12 months:

BBO-11818 and BBO-10203 monotherapy data update in the fourth quarter of 2026.
Expanded BBO-8520 plus pembrolizumab dataset in 2L+ KRASG12C inhibitor-experienced NSCLC expected in mid-2027.
Data from BBO-11818 and BBO-10203 internal and standard-of-care combination cohorts in colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) expected in mid-2027.

(Press release, BridgeBio Oncology Therapeutics, SEP 8, 2026, View Source [SID1234670660])