Did MEI/Kyowa Kirin Beat The PI3K Tolerability Trap?
Zandelisib Shows Unexpectedly Positive Data
PI3K-delta inhibitors have often suffered from safety and tolerability issues, but Phase II data show higher efficacy and lower discontinuation rates for zandelisib than others in the class.
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The company said it would discontinue the Phase III LIMBER-304 trial in patients who had inadequate response to Jakafi when an analysis indicated the study would not reach its primary endpoint.
Presentations at EHA show the drug has a favorable safety profile compared with other PI3K-delta inhibitors alone and in combination with Rituxan, plus strong efficacy.
MEI/Kyowa Kirin will no longer seek accelerated approval based on a single-arm study as the FDA is calling for Phase III data due to growing conservatism regarding the PI3K class.