Table 2.
Tumor-associated assessments based on a blinded central radiology review of the primary efficacy population
| BTH1677/Bevacizumab/ Carboplatin/Paclitaxel (N = 48) |
Bevacizumab/ Carboplatin/Paclitaxel (N = 23) |
||||
|---|---|---|---|---|---|
| n (%) | 95% CI | n (%) | 95% CI | P valuef | |
| Objective Response Ratea,b | 29 (60.4) | (45.3, 74.2) | 10 (43.5) | (23.2, 65.5) | 0.2096 |
| Disease Control Rateb,c | 45 (93.8) | (82.8, 98.7) | 21 (91.3) | (72.0, 98.9) | 0.6563 |
| Best Observed Responseb | |||||
| Complete response | 1 (2.1) | (0.1, 11.1) | 0 | NA | |
| Partial response | 28 (58.3) | (43.2, 72.4) | 10 (43.5) | (23.2, 65.5) | 0.3113 |
| Stable disease | 16 (33.3) | (20.4, 48.4) | 11 (47.8) | (26.8, 69.4) | 0.2992 |
| Progressive disease | 3 (6.3) | (1.3, 17.2) | 2 (8.7) | (1.1, 28.0) | 0.6563 |
| Duration of Objective Tumor Responsed | HR (95% CI)g | ||||
| Patients with objective response (CR + PR) | 29 | 10 | |||
| Patients (% responding patients) with known duration (uncensored) | 9 (31.0) | 3 (30.0) | |||
| Patients (% responding patients) with unknown duration (censored) | 20 (69.0) | 7 (70.0) | |||
| Duration of objective response (months) | |||||
| Median (95% CI) | 10.3 (5.6, NE) | 5.6 (1.5, NE) | 0.92 (0.27, 4.20) | ||
| Log-rank P value | 0.9040 | ||||
| Progression-Free Survivale | HR (95% CI)g | ||||
| Patients with PD or died, n (%) | 17 (34.0) | 6 (26.1) | |||
| Patients censored, n (%) | 33 (66.0) | 17 (73.9) | |||
| Progression-free survival (months) | |||||
| Median (95% CI) | 11.6 (7.0, NE) | 9.6 (7.1, NE) | 1.31 (0.54, 3.65) | ||
| Log-rank P value | 0.5639 | ||||
Abbreviations: CI confidence interval, CR complete response, NA not applicable, PD progressive disease, PR partial response, HR hazard ratio, n number of patients, N overall sample size, NE not estimable
aObjective response rate was defined as the percent of central radiology review response-evaluable patients experiencing a best overall tumor
response of either CR or PR at any time on study according to modified RECIST v1.0 criteria
bTumor response data reported as the number (n) and percent (%) of response-evaluable patients and the 95% exact binomial confidence interval
cDisease control rate was defined as the percent of blinded central radiology review response-evaluable patients experiencing a best overall tumor response of CR, PR, or stable disease (SD) per modified RECIST v1.0 criteria
dDuration of objective response (months) was based on Kaplan-Meier estimates and was measured from the time at which criteria were met for CR or PR (whichever status was recorded first) until the first date on which recurrence or progressive disease (PD) was objectively documented per modified RECIST v1.0. Patients who did not progress as of the data cutoff date were censored at their last tumor assessment
eProgression-free survival (PFS) (months) was based on Kaplan-Meier estimates from the total blinded central radiological review population (BTH1677/Bevacizumab/Carboplatin/Paclitaxel, n = 50 and Bevacizumab/Carboplatin/Paclitaxel, n = 23) and was defined as the time from randomization to the first date of documented PD or death. PD was identified by radiologic PD according to modified RECIST v1.0. If a patient received any further anticancer therapy without prior documentation of PD, the patient was censored at the date of last imaging assessment before the treatment. Patients who were lost to follow-up or who were alive without PD as of the data cut-off date were censored at the last imaging assessment date or at the analysis data cut-off date, whichever came first
fP value was obtained using Fisher’s Exact Test
gHazard ratio (95% exact binomial CI) was based on Cox proportional hazards model with treatment as factor