The company said Cylembio plus Keytruda demonstrated clinical improvement in progression-free survival compared to Keytruda alone, but statistical significance was “narrowly” missed.
IO Biotech (IOBT) announced on Monday that its investigational and therapeutic cancer vaccine, Cylembio, in combination with Merck’s (MRK) Keytruda, failed to achieve statistical significance in progression-free survival improvement in a late-stage trial compared to Keytruda alone.
IOBT stock traded over 19% lower on Monday morning, at the time of writing. The company said Cylembio plus Keytruda demonstrated clinical improvement in progression-free survival compared to Keytruda alone, but statistical significance was “narrowly” missed. Improvement in progression-free survival was achieved across virtually all subgroups, including those with poor prognostic factors, the company said.
The trial evaluated Cylembio in combination with Keytruda versus Keytruda alone in 407 patients with previously untreated, unresectable, or metastatic (advanced) melanoma. Patients in the study treated with Cylembio in combination with Keytruda achieved 19.4 months of median progression-free survival compared to 11.0 months in patients treated with Keytruda alone. Progression-free survival (PFS) refers to the length of time during and after cancer treatment that a patient lives without the disease worsening.
On Stocktwits, retail sentiment around IOBT jumped from ‘neutral’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘normal’ to ‘extremely high’ levels.
A Stocktwits user expressed optimism about the data.
Another opined that the stock price should multiply by 10 times in the aftermath of the data release.
A trend toward an improvement in overall survival was also observed in the study, though data is not yet mature, the company said. Overall survival (OS) is a key metric in clinical trials, particularly for cancer, representing the length of time from a specific event (like diagnosis or treatment start) that patients remain alive.
“The magnitude and durability of clinical effect observed consistently across subgroups supports our confidence in Cylembio and its potential as a treatment for advanced melanoma patients. We look forward to engaging with the FDA to determine a potential path to approval based on these data,” said Mai-Britt Zocca, CEO of IO Biotech.
IO Biotech plans to meet with the U.S. Food and Drug Administration (FDA) this fall to discuss the data and determine next steps for submission of a Biologics License Application (BLA) for the treatment of advanced melanoma.
IOBT stock is up by 59% this year and by about 12% over the past 12 months.
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