Table 2.
Efficacy in cohorts A and B and according to bone involvement
| Parameter | All non Squamous (N/%) | All Squamous (N/%) | Non SquamousBoM+ (N/%) | Non-SquamousBoM- (N/%) | p | Squamous BoM+ (N/%) | Squamous BoM- (N/%) |
p |
|---|---|---|---|---|---|---|---|---|
| Response | ||||||||
| • CR | 12/1 | 4/1 | 7/1 | 5/1 | < 0.0001* | 0/0 | 4/2 | 0.04* |
| • PR | 278/17 | 65/18 | 66/11 | 212/22 | 15/13 | 50/20 | ||
| • SD | 414/26 | 108/28 | 137/22 | 277/29 | 25/21 | 83/33 | ||
| • PD | 818/52 | 189/50 | 393/63 | 425/44 | 78/65 | 111/44 | ||
| • NV | 66/4 | 5/3 | 23/3 | 43/4 | 2/2 | 3/1 | ||
|
Median PFS (months/range) |
3.0 (2.9–3.1) | 4.2 (3.4–5.0) | 3 (2.9–3.1) | 4 (3.5–4.5) | < 0.0001 | 2.7 (2.2–3.2) | 5.2 (4.3–6.0) | < 0.0001 |
| 12 months PFS (%) | 23 | 27 | 15 | 27 | < 0.0001 | 15 | 31 | < 0.0001 |
|
Median OS (months/range) |
11.3 (10.2–12.4) | 7.9 (6.2–9.6) | 7.4 (6.0–8.8) | 15.3 (13.2—17.4) | < 0.0001 | 5 (3.9–6.1) | 10.9 (8.4–13.4) | < 0.0001 |
| 12 months OS (%) | 48 | 39 | 38 | 55 | < 0.0001 | 19 | 48 | < 0.0001 |
*p value was calculated in CR + PR versus SD + PD