IO Biotech Announces Positive Outcome of Interim Analysis of Phase 2 Randomized Trial in First Line Non-small Cell Lung Cancer
Data position the company to start potential registrational trials with two drugs in two tumor types
Copenhagen, Denmark – February 25, 2020: IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune modulating anti-cancer therapies based on its proprietary T-win® technology, announced the successful outcome of a scheduled interim analysis of the ongoing Phase 2 trial (IO102-012/KEYNOTE-764) of its lead cancer therapeutic vaccine, IO102, in non-small cell lung cancer (NSCLC). In this randomized trial, IO102 is being tested in combination with Merck’s anti-PD1 therapy, Keytruda (pembrolizumab) as a first-line therapy in patients with metastatic non-small cell lung cancer. The interim analysis was designed as a futility analysis. The Safety Monitoring Committee has recommended to continue the trial without modifications as the futility boundary was successfully passed.
“We set a very high hurdle for the futility boundary for the interim analysis in this difficult to treat disease. Specifically, the successful outcome of this interim analysis required the objective response rate in the experimental arm to exceed the futility boundary which was substantially higher than the historical experience with Keytruda monotherapy in this population. We are excited to note that this hurdle has been successfully crossed,” said Eva Ehrnrooth, MD, PhD, chief medical officer of IO Biotech. “Through this trial, we expect to get a comprehensive data set that paves the way for a potential pivotal trial of IO102 addressing the unmet medical need in NSCLC and solid tumors.”
“The year 2020 will be a transformational year for IO Biotech. We are pleased by the data generated thus far in the ongoing trial of our off-the-shelf subcutaneous injectable treatment for patients with lung cancer. Additionally, the exciting data being generated in the ongoing melanoma trial with our proprietary T-win cocktail that includes IO102 and IO103 (our two clinical lead programs based on targeting IDO and PD-L1) will allow the company to initiate pivotal trials in two indications with two drugs,” said Mai-Britt Zocca, PhD, CEO and Founder of IO Biotech. “We continue to demonstrate long term durability of drug effect with a very attractive safety profile for each of our clinical stage candidates, whether alone or in any combination.”
IO Biotech’s lead candidate, IO102, is an Indoleamine 2,3-dioxygenase (IDO) derived immune modulating therapy with a dual mode of action – killing both cancer cells and immune-suppressive cells. IO Biotech’s IDO-derived immune modulating therapies previously demonstrated both a favorable safety profile and promising anti-tumor activity in its first human clinical trial of heavily pre-treated patients with NSCLC.
Contacts
Mai-Britt Zocca, PhD, CEO and founder of IO Biotech
E-mail: mz@iobiotech.com