In the dose optimization stage of the randomized Phase 2 trial (Duravelo-2), zelenectide pevedotin at its optimal dose in combination with pembrolizumab demonstrated response rates comparable to published data for standard of care (SOC) in patients with previously untreated metastatic urothelial cancer (mUC)

The optimal dose of zelenectide demonstrated a potentially differentiated safety profile with incidence rates approximately four-fold lower for skin reactions and half that for peripheral neuropathy as published for SOC

Further data from the randomized Phase 2 trial are expected in 2H 2026

In a separate Phase 1 trial (Duravelo-1) in previously untreated, cisplatin-ineligible mUC, zelenectide in combination with pembrolizumab demonstrated a clinically meaningful median progression-free survival comparable to published data for SOC

These data provide further validation of the potential of Bicycle® technology to deliver oncology therapeutics with improved benefit/risk profiles compared to existing modalities

Bicycle Therapeutics plc (NASDAQ:BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced the presentation of initial data from the randomized Phase 2 trial (Duravelo-2) evaluating zelenectide pevedotin (zelenectide) in previously untreated patients with metastatic urothelial cancer (mUC), demonstrating encouraging response rates and a potentially differentiated safety profile both as a monotherapy and in combination with pembrolizumab. In addition, updated data from the Phase 1 trial (Duravelo-1) in previously untreated, cisplatin-ineligible mUC patients demonstrated encouraging median progression-free survival (PFS) comparable to published data for standard of care (SOC). The data announced today will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 - June 2 in Chicago.