BOLD-100 Phase 2 Success in Advanced mCRC at ASCO GI 2024

Bold Therapeutics, a biopharmaceutical firm, has reported encouraging interim results from its Phase 2 clinical trial of BOLD-100, a metallotherapeutic drug, in combination with FOLFOX chemotherapy for the treatment of advanced metastatic colorectal cancer (mCRC). The study, known as BOLD-100-001 (NCT04421820), is a multinational effort involving patients from Canada, the United States, Ireland, and South Korea, and has enrolled 109 individuals with various gastrointestinal cancers.

The primary focus of the trial is on progression-free survival (PFS), with overall survival (OS) and objective response rate (ORR) serving as secondary measures. An additional metric, disease control rate (DCR), is also being monitored. The interim data, presented at a clinical poster session, revealed that patients who received BOLD-100 in conjunction with FOLFOX demonstrated a median PFS of 3.9 months and a median OS of 9.6 months. Among the 29 patients evaluated for response, an ORR of 7.0% was observed, translating to two partial responses and a DCR of 76%.

The drug BOLD-100 is distinguished by its unique mechanism of action, targeting a replication and survival pathway that is crucial across various cancer types. It has shown to be well-tolerated, with the majority of treatment-emergent adverse events being manageable. Notably, the incidence of neurotoxicity was lower than anticipated, considering the patients' prior exposure to oxaliplatin, a neurotoxic agent.

Jim Pankovich, the Executive Vice President of Clinical Development at Bold Therapeutics, highlighted the drug's favorable safety profile, which has enabled patients to continue treatment for an extended period. This, in turn, could potentially enhance the therapeutic impact. The findings from the study suggest that BOLD-100, when combined with FOLFOX, offers clinical benefits that are comparable or superior to existing treatments for advanced mCRC, such as Lonsurf®, Stivarga®, and Fruzaqla®.

E. Russell McAllister, the CEO of Bold Therapeutics, expressed optimism about the company's mission to improve outcomes for patients with hard-to-treat cancers. He anticipates moving BOLD-100 into late-stage studies with an aim for FDA approval in 2027 for the treatment of advanced mCRC.

The complete results for the Phase 2 trial, including data on safety and efficacy in biliary tract and gastric cancer, are currently under wraps but are slated for public presentation at an upcoming significant cancer conference. The company's ongoing commitment to advancing BOLD-100 reflects its dedication to addressing unmet needs in cancer treatment.