- 50% confirmed overall response rate, including one (13%) confirmed complete response in eight urothelial cancer patients dosed at 5.0mg/m2 weekly
- Median duration of response not yet reached in the 2.5mg/m2 and 5.0mg/m2 weekly cohorts; four of five responders in these cohorts still on therapy after at least 24 weeks
- Tolerability profile maintained over time, with low incidence of skin, ocular and neurological toxicities showing potential for differentiation from antibody-based approaches
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“Since our initial BT8009 Phase I/II trial interim results last year, we are encouraged to see BT8009’s promising profile endure over time. Over the last six months, the preliminary anti-tumor findings have been confirmed, the initial responses have deepened and remained durable, and the tolerability profile remains unchanged,” said
“As previously hypothesized, we believe that the differentiated pharmacokinetic profile of BTCs has the potential to deliver improved outcomes for patients and it is pleasing to see these clinical data mature and with it, the promise for a potentially industry-leading product profile,” said
- Four response evaluable UC patients were dosed at 2.5mg/m2 weekly. Among these four patients, one patient was observed to have tumor reductions constituting a confirmed partial response (PR) and two patients were observed to have stable disease (SD), reflecting a 25% overall response rate (ORR) and 75% disease control rate (DCR) in patients in this cohort.
- Eight response evaluable UC patients were dosed at 5.0mg/m2 weekly. Among these eight patients, four patients were observed to have a confirmed complete response (CR) or PR, including one patient with a CR and three patients with a PR, and two patients with SD, reflecting a 50% ORR and a 75% DCR in UC patients for this cohort. Prior to enrollment, all patients in this cohort had previously received at least two prior lines of therapy, with a median of three.
- The median duration of response has not yet been reached in either the 2.5 mg/m2 or 5.0mg/m2 cohort. Four of the five responders have ongoing Response Evaluation Criteria in Solid Tumors (RECIST) tumor responses. As of the
March 7, 2022data cutoff date, all four of these patients have a treatment duration of at least 24 weeks and all four remain on therapy.
- Tolerability profile remains consistent with earlier results from this trial. No dose limiting toxicities have been observed in the 2.5mg/m2 or the 5.0mg/m2 cohorts, and with longer-term follow-up, incidence of skin and eye toxicity, neuropathy and hyperglycemia remains low.
- Phase I dose escalation is ongoing. Exploration of additional doses and frequencies continues, and Bicycle intends to provide further updates this year.
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Forward Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Bicycle’s anticipated advancement of its product candidates, including BT8009, and participation in the AACR Annual Meeting. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the intentions disclosed in these forward-looking statements as a result of various factors, including: Bicycle’s abilities to meet other anticipated deadlines presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of clinical trials and clinical development of Bicycle’s product candidates; and other important factors, any of which could cause Bicycle’s actual results to differ from those contained in the forward-looking statements, and which are described in greater detail in the section entitled “Risk Factors” in Bicycle’s Annual Report on Form 10-K filed with the
VP, Capital Markets & Investor Relations