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We do see relatively high proportion of GI TEAE, prominently 65% nausea and 60% vomiting at the highest dose (1.2mg), and we see a dose dependent profile on AEs (pg 159 of S-1)
AstraZeneca supported its supplemental application with data from the Phase III AEGEAN study, in which the Imfinzi regimen elicited a 17.21% pathological complete response rate, compared to 4.28% in the placebo arm
and those with a BMI over 35.
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As the field of drug development continues to evolve, the importance of toxicology studies and understanding FDA guidelines is increasingly apparent