Table 2 Efficacy summary.
PFS (36 events) | OS (35 deaths) | |||
|---|---|---|---|---|
All patients | ||||
(N = 39) | ||||
6 months (95% CI) | 59% (42–72) | 74% (58–85) | ||
12 months | 33% (19–48) | 62% (45–75) | ||
36 months | 13% (5–25) | 23% (11–37) | ||
Median, months | 7.9 (4.6–10.5) | 15.5 (10.0–27.5) | ||
EGFR status at baseline (tissue) | ||||
Confirmed | Suspected | Confirmed | Suspected | |
(N = 21) | (N = 18) | (N = 21) | (N = 18) | |
6 months | 76% (52–89) | 39% (17–60) | 86% (62–95) | 61% (35–79) |
12 months | 48% (26–67) | 17% (4–37) | 81% (57–92) | 39% (17–60) |
36 months | 24% (9–43) | 0% | 38% (18- 58) | 6% (0–22) |
Median, months | 10.5 (6.5–27.5) | 3.2 (2.6–7.9) | 29.7 (13.8–47.7) | 10.0 (3.9–16.3) |
EGFR status at baseline (ctDNA) | ||||
EGFR mutant | Not EGFR mutant | EGFR mutant | Not EGFR mutant | |
(N = 24) | (N = 14) | (N = 24) | (N = 14) | |
6 months | 58% (36–75) | 64% (34–83) | 75% (53–88) | 79% (47–93) |
12 months | 38% (19–56) | 29% (9–52) | 67% (44–82) | 57% (28–78) |
36 months | 13% (3–29) | 14% (2–37) | 25% (10–43) | 21% (5–45) |
Median, months | 7.9 (4.6–14.3) | 6.5 (2.6–23.7) | 14.8 (6.7–33.4) | 16.3 (4.1–34.9) |
Exon 19 deletion or L858R (tissue or ctDNA)a | ||||
Yes | No | Yes | No | |
(N = 21) | (N = 18) | (N = 21) | (N = 18) | |
6 months | 71% (47–86) | 44% (22–65) | 86% (62–95) | 61% (35–79) |
12 months | 48% (26–67) | 17% (4–37) | 86% (62–95) | 33% (14–55) |
36 months | 24% (9–43) | 0% | 33% (15–53) | 11% (2–30) |
Median, months | 10.5 (5.9–19.8) | 4.4 (2.6–6.7) | 24.8 (14.2–39.3) | 6.7 (4.0–16.3) |
Baseline ctDNA values becoming undetectable during serial measurementsb | ||||
ctDNA clearance | No clearance | ctDNA clearance | No clearance | |
(N = 14) | (N = 4) | (N = 14) | (N = 4) | |
6 months | 86% (54–96) | 0% | 93% (59–99) | 50% (6–84) |
12 months | 50% (23–72) | 0% | 86% (54–96) | 50% (6–84) |
36 months | 21% (5–45) | 0% | 36% (13–59) | 0% |
Median, months | 10.5 (6.7–19.8) | 4.6 (2.8–N/A) | 21.1 (12.6–54.5) | 5.2 (4.8–N/A) |
