Table 2. Multivariate Analysis of Factors Associated With Best Overall Responsea.
| Risk factor at baseline | Effect | OR (95% CI) | P value |
|---|---|---|---|
| Baseline albumin/albumin ULN | Units = −1b | 0.16 (0.05-0.49) | .001 |
| LDH level | Elevated vs normal | 0.61 (0.47-0.79) | <.001 |
| Tumor size | >93 mm vs ≤93 mmc | 0.47 (0.36-0.61) | <.001 |
| Ipilimumab exposure | Ipilimumab exposed vs ipilimumab naive | 0.71 (0.56-0.91) | .006 |
| Prior systemic BRAFi therapy | Yes vs no | 0.71 (0.52-0.97) | .030 |
| PD-L1 status | Negative vs positive | 0.52 (0.37-0.73) | <.001 |
| Sex | Female vs male | 0.64 (0.50-0.81) | <.001 |
Abbreviations: BRAFi, BRAF inhibitor; LDH, lactate dehydrogenase; OR, odds ratio; PD-L1, programmed death ligand 1; ULN, upper limit of normal.
a
Analysis included all response-evaluable patients, regardless of BRAF V600E/K mutation status. Overall response was determined by Response Evaluation Criteria in Solid Tumors, version 1.1, per investigator review.
b
A 1-unit decrease was used to ensure the OR direction for all risk factors was the same.
c
Cutoff chosen based on the value that showed the most significant difference in response.