Bicycle Therapeutics Announces Expedited Development Plan for BT8009 in Metastatic Bladder Cancer

  • Alignment with U.S. FDA on design of Phase 2/3 registrational trial, to be initiated in 1Q 2024
  • Innovative study design allows for potential accelerated approval in untreated (first-line) and previously treated (second-line plus) metastatic bladder cancer
  • Conference call and webcast today at 8 a.m. ET

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Sep. 11, 2023– Bicycle Therapeutics (Nasdaq: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced the company will proceed with its plan to expedite development of BT8009 for metastatic bladder (urothelial) cancer following recent discussions with the U.S. Food and Drug Administration (FDA). The company has aligned with the FDA on a Phase 2/3 registrational trial, called Duravelo-2, that has an innovative design allowing for potential accelerated approval in untreated (first-line) and previously treated (second-line plus) metastatic bladder cancer. The company plans to initiate the Duravelo-2 trial in the first quarter of 2024.

“We prepared a robust and innovative clinical development plan for BT8009, with the goal of getting this much-needed therapy to patients as quickly as possible. We are pleased to have reached alignment with the FDA on the registrational trial design, dose selection and clinical trial endpoints that could support potential accelerated approval in a broad metastatic bladder cancer population,” said Santiago Arroyo, M.D., Ph.D., chief development officer at Bicycle Therapeutics. “In preparation for this positive outcome, we have put in place the clinical infrastructure that will allow us to start the registrational trial early next year.”

The Phase 2/3 Duravelo-2 trial will assess BT8009 in untreated metastatic bladder cancer (Cohort 1) and previously treated metastatic bladder cancer (Cohort 2). In Cohort 1, two doses of BT8009 plus standard pembrolizumab regimen will be initially assessed. Following selection of the optimal dose, BT8009 plus pembrolizumab will be evaluated against chemotherapy. Potential accelerated approval will be determined by objective response rate (ORR), and progression-free survival (PFS) will be used to confirm clinical benefit.

In Cohort 2, two doses of BT8009 as monotherapy will be initially studied. Following selection of the optimal dose, an additional arm of BT8009 plus standard pembrolizumab regimen will be added. Potential accelerated approval for BT8009 monotherapy and in combination with pembrolizumab will be determined by ORR compared to historical control data. Discussions with the FDA about the design of the confirmatory trial for previously treated metastatic bladder cancer are ongoing.

“At Bicycle Therapeutics, we are committed to using our novel platform to develop precision targeted therapeutics and improve the lives of patients who are battling devastating diseases. This is why, in line with the philosophy of the FDA’s Project FrontRunner and following the agency’s recent draft guidance on accelerated approval of oncology therapeutics, we have initially focused on defining the regulatory path for BT8009 in untreated patients. We believe today’s announcement is good news for patients, and we are greatly appreciative of the FDA for their collaboration and guidance,” said Kevin Lee, Ph.D., chief executive officer of Bicycle Therapeutics. “As we look to the rest of 2023, we continue to make progress in our research and development programs and look forward to providing updates on BT8009, BT5528 and BT7480 later this year.”

Conference Call and Webcast Information
Bicycle Therapeutics will host a conference call and webcast today, September 11, 2023, at 8 a.m. ET to review the BT8009 regulatory update. To access the call, please dial 1-833-816-1408 (U.S.) or +1 412-317-0501 (international) and ask to be joined into the Bicycle Therapeutics call. A live webcast and replay of the conference call will be available in the Investor section of the Bicycle website,

About BT8009
BT8009 is an investigational Bicycle Toxin Conjugate (BTC™) targeting Nectin-4, a well-validated tumor antigen with elevated levels of expression in multiple tumor types, including bladder (urothelial) cancer. It is currently being evaluated in a Phase 1/2 clinical trial enrolling patients with Nectin-4 expressing advanced solid tumors. BT8009 will be evaluated in the Phase 2/3 Duravelo-2 trial, a global, multi-center, adaptive study designed to assess the safety and efficacy of the therapy for metastatic bladder cancer.