Bold Therapeutics Reports Positive Phase 2 Results for BOLD-100 in Metastatic Biliary Tract and Gastric Cancers at ASCO 2024

Bold Therapeutics, a pioneer in metallotherapeutics, announced encouraging Phase 2 trial results for their lead compound, BOLD-100, targeting advanced metastatic biliary tract cancer (BTC) and gastric cancer (GC). The findings were unveiled at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, following the positive results presented earlier this year at the ASCO Gastrointestinal Cancers Symposium for advanced colorectal cancer treatment.

The multinational Phase 2 trial (NCT04421820) evaluated BOLD-100 combined with the standard FOLFOX chemotherapy regimen in patients with advanced gastrointestinal cancers. The trial sites included Canada, the United States, Ireland, and South Korea. Specific results were shared in two abstracts during the Gastrointestinal Cancer session on June 1, 2024.

Biliary Tract Cancer (BTC) Results

Analysis included 18 out of 22 patients eligible for efficacy evaluation:
- Median Progression-Free Survival (PFS): 6.0 months [95% CI: 3.8 – 10.0]
- Median Overall Survival (OS): 7.3 months [95% CI: 4.5 – 13.0], indicating favorable outcomes compared to standard treatments
- Partial Response (PR): Achieved by one patient (6% ORR) 
- Stable Disease (SD): Seen in 14 patients, yielding an 83% Disease Control Rate (DCR) [95% CI: 62.0, 95.0]
- Patients received a median of 4 therapy cycles (range 1 – 41)
- Common Treatment-Related Adverse Events (TRAEs): Neutrophil count decrease (46%), nausea (36%), fatigue (32%), peripheral-sensory neuropathy (27%), and pyrexia (27%)

Gastric Cancer (GC) Results

Analysis included 18 out of 21 patients eligible for efficacy evaluation:
- Median PFS: 4.2 months [95% CI: 2.8 – 7.1]
- Median OS: 7.9 months [95% CI: 4.8 – 15.0], again showing better outcomes relative to standard practices
- Partial Response (PR): Achieved by two patients (11% ORR)
- Stable Disease (SD): Observed in 11 patients, leading to a 72% DCR [95% CI: 49.0, 89.0]
- Patients underwent a median of 6 therapy cycles (range 1 – 27)
- Common TRAEs: Neutrophil count decrease (33%), nausea (29%), and peripheral-sensory neuropathy (19%), predominantly grade 1-2 severity

Future Directions

E. Russell McAllister, CEO of Bold Therapeutics, attributed the successes to the company’s dedicated team and support from Canadian government grants. He anticipates releasing compelling nonclinical biomarker data later this year, which may challenge existing paradigms in treating difficult solid tumors.

In the coming weeks, Bold Therapeutics will commence a Phase 2 randomized clinical trial to compare two different doses of BOLD-100 combined with FOLFOX against FOLFOX alone in second-line colorectal cancer patients. They aim to demonstrate significant improvements in safety and efficacy. Additionally, the company is gearing up to produce drug material for an imminent Phase 3 trial targeting advanced colorectal cancer.

Bold Therapeutics remains committed to advancing the treatment landscape for challenging cancers with innovative metallotherapeutic approaches, promising better patient outcomes where current treatments fall short.

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