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Table 3 Summary of best overall response per RECIST 1.1 criteria (full analysis set, phase 1b/2)

From: Binimetinib in combination with nivolumab or nivolumab and ipilimumab in patients with previously treated microsatellite-stable metastatic colorectal cancer with RAS mutations in an open-label phase 1b/2 study

 

Doublet Arms

Triplet Arms

 

Arm 1A (n = 10)

Arm 2A (n = 27)

Pooled (n = 37)

Arm 1B (n = 11)

Arm (2B n = 27)

Pooled (n = 38)

Best overall response, n (%)a, b

 CR

0

0

0

0

0

0

 PR

0

0

0

0

2 (7.4)

2 (5.3)

 SD

6 (60.0)

11 (40.7)

17 (45.9)

4 (36.4)

13 (48.1)

17 (44.7)

 PD

4 (40.0)

15 (55.6)

19 (51.4)

3 (27.3)

10 (37.0)

13 (34.2)

 Not evaluable

0

1 (3.7)

1 (2.7)

4 (36.4)

2 (7.4)

6 (15.8)

Overall response rate (CR + PR), n (%)b

[90% CI]

[95% CI]

0

0

0

0

2 (7.4)

[1.3, 21.5]

[0.9, 24.3]

2 (5.3)

[0.9, 15.7]

[0.6, 17.7]

Disease control rate (CR + PR + SD), n (%)

[95% CI]

6 (60.0)

[26.2, 87.8]

11 (40.7)

[22.4, 61.2]

17 (45.9)

[29.5, 63.1]

4 (36.4)

[10.9, 69.2]

15 (55.6)

[35.3, 74.5]

19 (50.0)

[33.4, 66.6]

  1. CR Complete response, PD Progressive disease, PR Partial response, SD Stable disease
  2. aBest overall response is based on investigator's assessment using Response Evaluation Criteria in Solid Tumors version 1.1.
  3. bConfirmed