Table 4.

Clinical activity outcomes in HER2 -mutant NSCLC (enrolled analysis set)

Outcome	HER2-mutant NSCLC
	n = 11
Duration of follow-up, median (range), monthsa	11.5 (5.1–14.6)
Investigator-assessed outcomes
Best overall response with confirmation of CR/PR
CR	0
PR	8 (72.7)
SD	2 (18.2)
PD	1 (9.1)
NE	0
Confirmed ORR	8/11 (72.7)
95% CI	(39.0–94.0)
Confirmed DCRb	10/11 (90.9)
95% CI	(58.7–99.8)
TTR, monthsc
n/N	8/11
Median (95% CI)	1.4 (1.2–2.8)
Min, max	1.2, 5.4
Duration of response, monthsd
n/N	8/11
Median (95% CI)	9.9 (6.9–11.5)
Min, max	5.3+, 11.5
PFS, months
Median (95% CI)	11.3 (5.5–14.3)
Min, max	2.8, 14.3
Assessment by independent central review
Best overall response with confirmation of CR/PR
CR	0
PR	8 (72.7)
SD	2 (18.2)
PD	1 (9.1)
NE	0
Confirmed ORR	8/11 (72.7)
95% CI	(39.0–94.0)
Confirmed DCRb	10/11 (90.9)
95% CI	(58.7–99.8)
TTR, monthsc
n/N	8/11
Median (95% CI)	1.4 (1.2–1.4)
Min, max	1.2, 2.8
Duration of response, monthsd
n/N	8/11
Median (95% CI)	9.9 (6.9–11.5)
Min, max	3.3+, 11.5
PFS, months
Median (95% CI)	11.3 (8.1–14.3)
Min, max	1.3, 14.3
OS, months
Median (95% CI)	17.3 (17.3–NE)
Min, max	8.4, 20.9+

NOTE: All values are n (%), unless otherwise specified. Data cutoff for this analysis was February 1, 2019. Dashes indicate value not reached. Min and max include the censored observations; using “+” after value indicates censoring. Abbreviations: max, maximum; min, minimum; NE, not evaluable; ORR, objective response rate.

^aSafety analysis set.

^bDCR is calculated as the proportion of patients demonstrating CR, PR, or SD for a minimum of 6 weeks (±1 week) from date of first dose.

^cTTR was measured from the date of registration to the date at which criteria for CR or PR are first met.

^dDuration of response was measured from the time at which CR or PR criteria are first met until the first date of objectively documented PD.