Table 3:
Efficacy Results in SOPHIA (ITT Population)
| Efficacy Parameter | Margetuximab plus Chemotherapy (N = 266) | Trastuzumab plus Chemotherapy (N = 270) |
|---|---|---|
| Median PFS by BICR a , months (95% CI) | 5.8 (5.52–6.97) | 4.9 (4.17–5.59) |
| HR per Stratified Cox Model (95% CI) | 0.76 (0.59–0.98) | |
| Stratified Log-Rank Test p value (2 sided) | 0.0334 | |
| Median OS b , months (95% CI) | 21.6 (18.86–24.05) | 19.8 (17.54–22.28) |
| HR per Stratified Cox Model (95% CI) | 0.89 (0.69–1.13) | |
| Stratified Log-Rank Test p value (2 sided) | 0.3264 | |
| ORRa,* (95% CI) | 22.1 (17.1, 27.2) | 16.0 (11.6, 20.5) |
| Complete Response | 2.7% | 1.5% |
| Partial Response | 19.5% | 14.5% |
| Median DoR ** , months (95% CI) | 6.1 (4.1, 9.1) | 6.0 (4.0, 6.9) |
| Min-Max | 0.0 – 20.8+ | 0.0 – 15.7+ |
a
Data cut off 10-Oct-2018;
b
Data cut off 10-Sep-2019
*
In response evaluable patients (i.e., with measurable disease at baseline); n=262 in each treatment arm.
**
Calculated only for responders.
Source: Margetuximab Assessment Aid submitted to FDA (Study 04 CSR – Section 11.4.1.1.3 and Addendum 1 - Section 2.2.2)24