Table 4 Efficacy of conteltinib (CT-707) in patients with ALK-positive NSCLC
Response | Total | 50 mg QD | 100 mg QD | 200 mg QD | 300 mg QD | 450 mg QD | 600 mg QD | 800 mg QD | 300 mg BID |
|---|---|---|---|---|---|---|---|---|---|
All patients (n) | 60 | 2 | 7 | 3 | 3 | 13 | 18 | 3 | 11 |
 ORR (95% CI) | 53.3% (40.0–66.3) | 50.0% (1.3–98.7) | 42.9% (9.9–81.6) | 33.3% (0.8–90.6) | 66.7% (9.4–99.2) | 53.8% (25.1–80.8) | 55.6% (30.8–78.5) | 66.7% (9.4–99.2) | 54.5% (23.4–83.3) |
 DCR (95% CI) | 80.0% (67.7–89.2) | 50.0% (1.3–98.7) | 57.1% (18.4–90.1) | 33.3% (0.8–90.6) | 100.0% (29.2–100.0) | 92.3% (64.0–99.8) | 83.3% (58.6–96.4) | 100.0% (29.2–100.0) | 81.8% (48.2–97.7) |
 DoR (months) | |||||||||
  Median (95% CI) | 13.3 (6.60–22.2) | NE | 11.1 (5.61–15.0) | 5.51 (NE–NE) | 17.4 (9.06–25.8) | NE (3.74–NE) | 15.6 (1.80–22.2) | 17.3 (6.60–28.0) | 5.58 (1.80–10.6) |
 PFS (months) | |||||||||
  Median (95% CI) | 9.26 (6.73–15.7) | NE (1.21–NE) | 8.57 (0.95–15.9) | 3.25 (1.34–8.54) | 10.2 (4.92–28.8) | 26.9 (4.63–NE) | 13.2 (4.69–23.0) | 10.3 (7.72–29.2) | 7.68 (3.05–17.8) |
 Follow-up time (months) | |||||||||
  Median (95% CI) | 9.75 (6.63–12.5) | 7.75 (2.98–NE) | 9.52 (1.87–17.1) | 4.79 (2.33–NE) | 11.9 (6.63–NE) | 9.82 (4.13–28.7) | 14.2 (6.50–24.9) | 12.1 (9.33–NE) | 6.17 (2.82–18.9) |
ALK TKI-naïve (n) | 39 | 1 | 6 | 2 | 2 | 8 | 12 | 2 | 6 |
 ORR (95% CI) | 64.1% (47.2–78.8) | 100.0% (2.5–100.0) | 50.0% (11.8–88.2) | 50.0% (1.3–98.7) | 100.0% (15.8–100.0) | 87.5% (47.3–99.7) | 58.3% (27.7–84.8) | 50.0% (1.3–98.7) | 50.0% (11.8–88.2) |
 DCR (95% CI) | 82.1% (66.5–92.5) | 100.0% (2.5–100.0) | 66.7% (22.3–95.7) | 50.0 (1.3–98.7) | 100.0% (15.8–100.0) | 100.0% (63.1–100.0) | 75.0% (42.8–94.5) | 100.0% (15.8–100.0) | 83.3% (35.9–99.6) |
 DoR (months) | |||||||||
  Median (95% CI) | 15.0 (9.06–25.8) | NE | 11.1 (5.61–15.0) | 5.51 (NE–NE) | 17.4 (9.06–25.8) | NE (3.74–NE) | 16.5 (1.80–32.8) | 28.0 (NE–NE) | 10.6 (1.80–10.6) |
 PFS (months) | |||||||||
  Median (95% CI) | 15.9 (9.26–23.3) | NE | 11.3 (2.75–15.9) | 5.89 (3.25–8.54) | 19.5 (10.2–28.8) | NE (4.63–NE) | 19.3 (1.05–32.4) | 19.8 (10.3–29.2) | 17.8 (3.05–19.6) |
 Follow-up time (months) | |||||||||
  Median (95% CI) | 12.2 (6.17–18.9) | 12.5 (NE–NE) | 12.7 (3.74–NE) | 7.22 (4.79–NE) | 21.0 (11.9–NE) | 17.1 (2.75–52.5) | 20.8 (1.60–33.6) | 21.2 (12.1–NE) | 6.01 (2.49–NE) |
Received crizotinib previously (n) | 21 | 1 | 1 | 1 | 1 | 5 | 6 | 1 | 5 |
 ORR (95% CI) | 33.3% (14.6–57.0) | 0.0% (0.0–97.5) | 0.0% (0.0–97.5) | 0.0% (0.0–97.5) | 0.0% (0.0–97.5) | 0.0% (0.0–52.2) | 50.0% (11.8–88.2) | 100.0% (2.5–100.0) | 60.0% (14.7–94.7) |
 DCR (95% CI) | 76.2% (52.8–91.8) | 0.0% (0.0–97.5) | 0.0% (0.0–97.5) | 0.0% (0.0–97.5) | 100.0% (54.1–100.0) | 80.0% (28.4–99.5) | 100.0% (54.1–100.0) | 100.0% (2.5–100.0) | 80.0% (28.4–99.5) |
 DoR (months) | |||||||||
  Median (95% CI) | 6.60 (3.77–13.3) | NE | NE | NE | NE | NE | 13.3 (3.77–16.5) | 6.60 (NE–NE) | 5.58 (4.63–7.39) |
 PFS (months) | |||||||||
  Median (95% CI) | 6.73 (4.73–8.54) | 1.21 (NE–NE) | 0.95 (NE–NE) | 1.34 (NE–NE) | 4.92 (NE–NE) | 8.34 (3.02–26.9) | 9.37 (4.69–17.7) | 7.72 (NE–NE) | 7.09 (4.73–8.54) |
 Follow-up time (months) | |||||||||
  Median (95% CI) | 7.78 (4.82–9.69) | 2.98 (NE–NE) | 1.87 (NE–NE) | 2.33 (NE–NE) | 6.63 (NE–NE) | 9.69 (4.13–NE) | 9.90 (6.20–NE) | 9.33 (NE–NE) | 8.04 (2.82–NE) |