Efficacy
The ORR was 46% (95% confidence interval [CI], 36 to 57) amongst the 99 patients in the efficacy population. A complete response was not observed in any patient. Comparable responses were seen irrespective of baseline characteristics and number of lines of previous therapies. The results were also similar across the total number of patients enrolled who may have had less than 9 months of follow up.r
In the combined biopsy group (plasma and tissue biopsy positive N=99), median DOR was 11.1 months (95% CI, 7.2 to could not be estimated), median duration of PFS was 8.5 months (95% CI, 6.7 to 11.0). Median OS was 17.1 months (95% CI, 12.0 to 26.8) according to data which remain immature.
Kaplan-Meier estimates of PFS according to biopsy groupr
© N Engl J Med 2020
OS was not significantly different between plasma (N=66) or tissue biopsy (N=60) positive patients when compared to the combined biopsy group (N=99). Median OS was 15.8 months, 22.3 months and 17.1 months respectively.
OS for the three primary analysis populationsr
© N Engl J Med 2020