Table 3. Efficacy.
| Dosing schedule | Continuous arm 30 mg binimetinib BID + FOLFOX n = 3 |
Continuous arm 45 mg binimetinib BID + FOLFOX n = 13 |
Intermittent arm 45 mg binimetinib BID + FOLFOX n = 10 |
|---|---|---|---|
| Median duration of treatment (cycles) | 8 (range 3–12) | 5 (range 1–20) | 4 (range 4–8) |
| Number of cycles | 6 (range 1–20) | 4 (range 4–8) | |
| Best overall response CR PR SD** PD NA |
0 0 2 1 0 |
0 0 7# 3 3* |
0 0 1 9 |
| Clinical benefit rate (CR + PR + SD) |
66.6% | 54% | 10.0% |
| Median PFS (months) | 5.5 (95% CI 1.41- NR) | 3.5 (95% CI 1.9-NR) | 1.8 (95% CI 1.7-NR) |
| Median PFS (months) | 3.5 months (95% CI 1.9-NR) | 1.8 (95% CI 1.7-NR) | |
BID, twice daily; FOLFOX, 5-flourouracil, leucovorin, and oxaliplatin; CR, complete response; PR, partial response; SD, stable disease; PD, disease progression; PFS, progression-free survival; CI, confidence interval. *1 suicide, 1 early death considered a cardiac event, 1 off early for toxicity. **SD for at least 1 evaluation. #Prolonged SD of 9 months in 1 patient. 4 patients were censored for PFS at time of treatment discontinuation due to toxicity (2), surgery (1), and patient choice (1).