Table 3.
Summary of efficacy by treatment cohort (investigator review)
| Assessment | D + T + P (n = 91) | T + P (n = 31) | D + P (n = 20) | D + T(n = 43)a |
|---|---|---|---|---|
| Best confirmed response, n (%) | ||||
| CR | 1 (1) | 0 | 1 (5) | 1 (2) |
| PR | 18 (20) | 0 | 1 (5) | 2 (5) |
| SD | 59 (65) | 17 (55) | 16 (80) | 24 (56) |
| PD | 8 (9) | 12 (39) | 2 (10) | 10 (23) |
| NE | 5 (5) | 2 (6) | 0 | 6 (14) |
| ORR (CR + PR), n (%) [95% CI] | 19 (21)[13.1–30.7] | 0[0–11.2] | 2 (10)[1.2–31.7] | 3 (7) |
| DOR (95% CI), months | 7.6 (2.9-NR) | 0 | 6.9 (5.9–8.0) | -- |
| DCR (CR + PR + SD), % | 86 | 55 | 90 | 68 |
| Median PFS, months | 4.2 | 2.6 | 3.5 | 3.5 |
| Unconfirmed CR + PR, n (%) | 29 (32) | 1 (3) | 3 (15) | 5 (12) |
DCR, disease control rate; NE, not evaluable; NR, not reached; ORR, overall response rate; PD, progressive disease; SD, stable disease.
a
Key efficacy measures are shown across treatment arms. Efficacy data for patients treated with D + T (Corcoran RB, Atreya CE, Falchook GS, Kwak EL, Ryan DP, Bendell JC, et al. Combined BRAF and MEK inhibition with dabrafenib and trametinib in BRAF V600-mutant colorectal cancer. J Clin Oncol 2015;33(34):4023-31; ref 17) are shown for comparison.