Antibody-Drug Conjugates and Immunotoxins by Gail Lewis Phillips

Author:Gail Lewis Phillips
Language: eng
Format: epub
Publisher: Springer New York, New York, NY

95% CI for ORR

(28.6%, 46.6%)

(24.1%, 42.1%)

CI, confidence interval; CSR, clinical study report; IRF, independent review facility; ORR, objective response rate

aApproximately 12 months of follow-up after the last patient was enrolled

bApproximately 9 months of follow-up after the last patient was enrolled

Source: Refs. [26, 27]

In study TDM4258g, among patients with prior lapatinib treatment (n  =  67), the ORR was 24.2% (95% CI, 14.5–36.0%) by independent radiologic review and 34.8% (95% CI, 23.5–46.8%) per investigator [26]. Together with the primary results of study TDM4374g, T-DM1 had demonstrable efficacy in tumors of patients who had previously received both approved HER2-directed therapies.

Responses to T-DM1 treatment in many cases were durable (Table 11.5). Based on investigator assessment, the median duration of response was similar in the two studies: 9.7 months in TDM4374g and 9.4 months in TDM4258g. The ranges of duration of objective response were also similar between the two studies. In both studies, the median duration of response based on independent radiologic assessment was not reached due to insufficient events.Table 11.5Duration of objective response: responding patients in studies TDM4374g and TDM4258g

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