Puma Biotechnology (PBYI -2.6%) slips on below-average on the heels of preliminary results from a Phase 2 basket study, SUMMIT, evaluating neratinib in HER2-positive cancers. The data were presented at the ESMO World Congress on Gastrointestinal Cancer in Barcelona.
Investors appear disappointed with the results from the 20-subject biliary cancer cohort that received neratinib alone. The confirmed objective response rate (ORR) was only 10% (n=2/20), both partials, and the clinical benefit rate (responders + stable cancer) was 30% (n=6/20) (two partial responders + four with stable disease that lasted at least 16 weeks). Median progression-free survival (PFS) was only 1.8 months.
No new safety signals were observed.
The estimated primary completion date of the trial is September 2021.
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