Independent DMC recommends continuing HARMONi-3 study
Previously, Summit announced its intention to perform an interim PFS analysis for the squamous cohort of the HARMONi-3 study in the second quarter of 2026. As previously communicated, the purpose of this interim analysis was to provide a potential opportunity to speak with the regulatory authorities, including the US Food & Drug Administration, earlier than the timing of the preplanned final PFS analysis in the second half of 2026. To achieve statistical significance, there was a meaningfully higher bar than the upcoming planned final PFS analysis based on the minimal alpha spent on the interim analysis. At this early interim PFS analysis reviewed exclusively by the Independent Data Monitoring Committee (iDMC), the iDMC recommended that the study continue as planned. No safety concerns were noted, and the study continues to be double-blinded. There is no change to the previously guided timing of the preplanned final PFS analysis in the second half of 2026.
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