Bicycle rides onto its accelerated pathway

Last year Bicycle Therapeutics promised to begin the pivotal Duravelo-2 study of its lead asset, zelenectide pevedotin, in the first quarter of 2024, and it has already come through on this. New listings on the clinicaltrials.gov registry include this trial, with a formal start date of January. The total enrolment target of 956 bladder cancer patients broadly tallies with Bicycle’s stated aim of 626 in cohort 1 (first-line Keytruda combo versus chemo) and 300 in cohort 2 (second-line monotherapy), including 120 from dose optimisation; the entry shows co-primary endpoints split between cohort 1 progression-free survival and cohort 2 response rate. ORR from both cohorts, earlier called a primary endpoint but now technically listed as a secondary, is a key metric as it’s meant to support an accelerated approval filing, according to a pathway Bicycle claims to have had “alignment” on with the FDA. Whether such a quick pathway from a trial with a chemo comparator still exists after December’s approval of Merck & Co/Pfizer’s Keytruda/Padcev combo, based on the knockout result in the EV-302 study, is an open question.