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Bicycle Therapeutics presents at AACR Annual Meeting 2022 - Slideshow

BT8009 Clinical Trial - Key Findings - BT8009 shows promising clinical activity at a 5mg/m2 weekly dose, with potential for a differentiated product profile[20, 54] - At 5mg/m2 weekly, the Overall Response Rate (ORR) is 50% and the disease control rate is 75%, including a 13% complete response in urothelial cancer patients[20, 28, 42, 54] - Responses to BT8009 are durable, with tumor reductions maintained over time[20, 54] - The 7.5mg/m2 weekly dose was not tolerated due to GI and fatigue-related toxicities[20, 54] - BT8009 demonstrates linear pharmacokinetics and a short terminal half-life, as predicted from preclinical data[20, 54] Patient Demographics and Disease History - A total of 37 patients were enrolled in the BT8009 Phase I dose escalation trial[25, 27, 51] - The median age of patients in the trial is 66 years, ranging from 44 to 83 years[25] - 59% of patients are male, and 41% are female[25] - 41% of patients had an ECOG performance status of 0, while 59% had a status of 1[25] - Urothelial cancer represents 49% of the tumor types in the trial, followed by pancreatic cancer at 16%, and lung cancer at 14%[27, 52] Safety Profile - Common adverse events (≥15% incidence) include fatigue (40.5%), nausea (37.8%), diarrhea (32.4%), pyrexia (32.4%), anemia (32.4%), and decreased appetite (32.4%)[44] - Skin toxicity was observed in 19% of patients, with no Grade ≥3 severity[48] - Neuropathy was observed in 24% of patients, with 3% Grade ≥3 severity[48] - Ocular disorders were observed in 3% of patients, with no Grade ≥3 severity[48]