Cambridge-headquartered Bicycle Therapeutics is accelerating a timely battle against bladder cancer. The company, based at Granta Park in Cambridge but also with US facilities, is presenting key data at the American Society of Clinical Oncology Annual Meeting from May 29 – June 2 in Chicago.

Bicycle is a Nasdaq-quoted pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology.

The data being presented in Chicago presentations the initial read-out from a randomised Phase 2 trial (Duravelo-2) evaluating zelenectide pevedotin (zelenectide) in previously untreated patients with metastatic urothelial cancer (mUC).

It has demonstrated encouraging response rates and a potentially differentiated safety profile both as a monotherapy and in combination with pembrolizumab.

Also, updated data from the Phase 1 trial (Duravelo-1) in previously untreated, cisplatin-ineligible mUC patients showed encouraging median progression-free survival (PFS) comparable to published data for standard of care (SOC).

Bicycle CEO Kevin Lee said: “Despite recent advances for the treatment of bladder cancer, there remains an urgent need for more tolerable therapies. For instance, published clinical data for the current SOC for mUC demonstrate a significant number of tolerability-related drug discontinuations, and high rates of neuropathy and skin toxicities.

“In contrast, the initial Duravelo-2 data shared today demonstrate that zelenectide in combination with pembrolizumab continues to show response rates comparable to published data for SOC for mUC, while potentially offering substantially lower toxicity and improved tolerability for patients.

“We have now tested zelenectide as a monotherapy or in combination with pembrolizumab in more than 600 patients and have consistently observed lower rates and severity of neuropathy and skin toxicities. We believe that the extensive data we have generated in patients continue to demonstrate the unique nature of Bicycle molecules as targeting agents that offer a potentially differentiated tolerability profile to antibody-based approaches.

“We are excited to continue to explore these advantages with novel targets and novel payloads in our mission to help patients not only live longer but live well. Meanwhile, the Duravelo-2 trial has been converted into a randomised Phase 2 trial and we look forward to sharing further results in the second half of 2026.”