On June 3, 2024 Bold Therapeutics, the world leader in the development of novel metallotherapeutics, reported positive Phase 2 safety and efficacy results for the company’s lead asset BOLD-100 in the treatment of advanced metastatic biliary tract cancer (BTC) and gastric cancer (GC) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, IL (Press release, Bold Therapeutics, JUN 3, 2024, View Source [SID1234644043]). This follows positive Phase 2 results in the treatment of advanced colorectal cancer presented at the 2024 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January.

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BTC and GC data from Bold Therapeutics’ ongoing multinational Phase 2 clinical trial (NCT04421820) of BOLD-100 in combination with standard-of-care FOLFOX in the treatment of patients with advanced gastrointestinal cancers at sites in Canada, the United States, Ireland, and South Korea was presented as Abstract #4115 (Poster Board #95) "A Phase 2 Study of BOLD-100 in combination with FOLFOX chemotherapy in patients with pretreated advanced biliary tract cancer: efficacy and safety analysis" and Abstract #4059 (Poster Board #39) "A Phase 2 Study of BOLD-100 in combination with FOLFOX chemotherapy in patients with advanced gastric cancer: efficacy and safety analysis", respectively, in the Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary session on June 1, 2024, from 1:30 – 4:30PM CDT.

BTC Efficacy and Safety:

18 out of 22 patients treated were eligible for efficacy evaluation;
Patients had received a median of 2 prior therapies;
Median progression-free survival (PFS) of 6.0 months [95% CI: 3.8 – 10.0] and median OS of 7.3 months [95% CI: 4.5 – 13.0], which compares extremely favorably with standard-of-care outcomes;
One patient (n=1) achieving a partial response (PR) for an objective response rate (ORR) of 6% [95% CI: 1.0, 23.0], fourteen (n=14) patients with stable disease (SD), and disease control rate (DCR) of 83% [95% CI: 62.0, 95.0];
Patients received a median of 4 cycles (range: 1 – 41) of therapy; and
For all treated patients (n=21), 21 had ≥ 1 TRAEs, most commonly neutrophil count decrease (n=10, 46%), nausea (n=8, 36%), fatigue (n=7, 32%), peripheral-sensory neuropathy (n=6, 27%), and pyrexia (n=6, 27%).
GC Efficacy and Safety:

18 out of 21 patients treated were eligible for efficacy evaluation;
Patients had received a median of 4 prior therapies;
Median progression-free survival (PFS) of 4.2 months [95% CI: 2.8 – 7.1] and median OS of 7.9 months [95% CI: 4.8 – 15.0], which compares extremely favorably with standard-of-care outcomes;
Two patients (n=2) achieved a partial response (PR) for an objective response rate (ORR) of 11% [95% CI: 2.0, 31.0], eleven (n=11) patients with stable disease (SD), and disease control rate (DCR) of 72% [95% CI: 49.0, 89.0];
Patients received a median of 6 cycles (range: 1 – 27) of therapy; and
For all treated patients (n=21), 19 patients had ≥ 1 TRAEs, most commonly neutrophil count decrease (n=7, 33%), nausea (n=6, 29%), and peripheral-sensory neuropathy (n=4, 19%), with most AEs being grade 1-2.
"Driven by our dedicated and talented employees and supported by generous grants and subsidies from the government of Canada, BOLD-100 continues to exceed expectations," added E. Russell McAllister, CEO. "On top of the robustly positive Phase 2 clinical data presented at both ASCO (Free ASCO Whitepaper) and ASCO (Free ASCO Whitepaper) GI, Bold Therapeutics expects to announce intriguing nonclinical data later this year, specifically biomarker data that we think will generate significant excitement amongst both clinicians and scientists as we disrupt commonly held perceptions about how to safely and effectively treat some of the most difficult-to-treat solid tumor indications where existing therapies are largely ineffective."

Later this month, Bold Therapeutics expects to begin enrolling patients into a multinational Phase 2 randomized clinical trial comparing two different doses of BOLD-100 in combination with standard-of-care FOLFOX against standard-of-care FOLFOX in patients with second-line FOLFOX-naïve colorectal cancer. Based on prior results, we expect to see significant improvements in both safety and efficacy outcomes. In addition, Bold Therapeutics is currently manufacturing drug product to support a pivotal Phase 3 trial in advanced colorectal cancer.