Bicycle Therapeutics Advocates for Its Padcev Rival: ESMO24

Bicycle Therapeutics recently revealed promising results from an early-stage clinical study targeting bladder cancer. The study involved the experimental treatment BT8009, with a significant 45% response rate among the evaluated patients.

Out of 38 patients assessed for the treatment's effectiveness, one experienced complete cancer remission, while 16 saw their tumors shrink by at least 30%, indicating a partial response. This analysis focused on patients who received the BT8009 dosage that Bicycle plans to advance in further studies. The median duration of response among 14 patients who had confirmed responses was slightly over 11 months.

Bicycle Therapeutics is developing an innovative therapy designed to outperform Pfizer’s urothelial carcinoma drug, Padcev, particularly in terms of safety while maintaining similar efficacy. Padcev's pivotal clinical trial in third-line advanced bladder cancer demonstrated a 44% response rate among 125 patients. However, Padcev is associated with severe side effects such as significant skin reactions and peripheral neuropathy, a form of nerve damage. In contrast, Bicycle’s trial reported only 10 treatment-related adverse events among 45 patients assessed for safety, with no grade 3 or higher cases of neuropathy, skin reactions, or eye disorders.

Bicycle Therapeutics CEO Kevin Lee emphasized the need to improve tolerability profiles for antibody-drug conjugates (ADCs), which have been beneficial in terms of efficacy but still present challenges regarding side effects.

Additionally, Bicycle presented findings on peripheral neuropathy outcomes from their studies of BT8009 and another bicyclic drug, BT5528, across various solid tumors. Among 149 patients treated with BT8009, 42 experienced treatment-related peripheral neuropathy, but only one case was grade 3 or higher. Notably, no patients required drug withdrawal due to these side effects.

BT8009, similar to Padcev, targets nectin-4, a protein overexpressed in bladder and other cancers. However, Bicycle’s treatment uses a synthetic bicyclic peptide instead of an antibody. This two-ringed molecule aims to combine the benefits of both antibodies and small molecules, a technology that inspired the company’s name.

In the competitive landscape, Pfizer acquired Padcev through its $43 billion purchase of Seagen last year, while other companies like Eli Lilly are also developing nectin-4 targeted treatments.

Bicycle Therapeutics is set to report results from around 20 patients treated with BT8009 in combination with Keytruda by the end of this year. Furthermore, a Phase 2/3 study named Duravelo-2 is currently enrolling advanced bladder cancer patients to evaluate BT8009 as both a monotherapy and in conjunction with Keytruda.

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