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

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Excerpt from the Press Release:

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–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.

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