Investigator-assessed response rates in the chemotherapy-free cohort (arm A) and chemotherapy-containing cohort (arms B and C) using PET + CT scan (intent-to-treat population) and BOR in arm A (refractory and nonrefractory patient subgroups)
| N (%) . | Arm A: VEN + R (n = 52) . | Arm B: VEN + BR (n = 51) . | Arm C: BR (n = 51) . |
|---|---|---|---|
| Primary response assessment* | |||
| ORR | 18 (35) | 43 (84) | 43 (84) |
| CMR/CR | 9 (17) | 38 (75) | 35 (69) |
| 95% CI (Clopper-Pearson) | 8.23, 30.33 | 60.37, 85.67 | 54.11, 80.89 |
| Difference (95% CI) | NA | 5.88 (−11.59 to 23.35), P = .51 | |
| PMR/PR | 9 (17) | 5 (10) | 8 (16) |
| NMR/SD | 7 (14) | 0 | 1 (2) |
| PMD/PD | 23 (44) | 2 (4) | 5 (10) |
| Response data missing† | 3 (6) | 4 (8) | 2 (4) |
| 1 y follow-up‡ | |||
| ORR | 14 (27) | 25 (49) | 29 (57) |
| CMR/CR | 10 (19) | 22 (43) | 26 (51) |
| 95% CI (Clopper-Pearson) | 9.63, 32.53 | 29.35, 57.75 | 36.60, 65.25 |
| Difference (95% CI) | NA | −7.84 (−27.16 to 11.47), P = .43 | |
| PMR/PR | 4 (8) | 3 (6) | 3 (6) |
| NMR/SD | 3 (6) | 0 | 0 |
| PMD/PD | 32 (62) | 12 (24) | 15 (29) |
| Response data missing† | 3 (6) | 14 (28) | 7 (14) |
| N (%) . | Arm A: VEN + R (n = 52) . | Arm B: VEN + BR (n = 51) . | Arm C: BR (n = 51) . |
|---|---|---|---|
| Primary response assessment* | |||
| ORR | 18 (35) | 43 (84) | 43 (84) |
| CMR/CR | 9 (17) | 38 (75) | 35 (69) |
| 95% CI (Clopper-Pearson) | 8.23, 30.33 | 60.37, 85.67 | 54.11, 80.89 |
| Difference (95% CI) | NA | 5.88 (−11.59 to 23.35), P = .51 | |
| PMR/PR | 9 (17) | 5 (10) | 8 (16) |
| NMR/SD | 7 (14) | 0 | 1 (2) |
| PMD/PD | 23 (44) | 2 (4) | 5 (10) |
| Response data missing† | 3 (6) | 4 (8) | 2 (4) |
| 1 y follow-up‡ | |||
| ORR | 14 (27) | 25 (49) | 29 (57) |
| CMR/CR | 10 (19) | 22 (43) | 26 (51) |
| 95% CI (Clopper-Pearson) | 9.63, 32.53 | 29.35, 57.75 | 36.60, 65.25 |
| Difference (95% CI) | NA | −7.84 (−27.16 to 11.47), P = .43 | |
| PMR/PR | 4 (8) | 3 (6) | 3 (6) |
| NMR/SD | 3 (6) | 0 | 0 |
| PMD/PD | 32 (62) | 12 (24) | 15 (29) |
| Response data missing† | 3 (6) | 14 (28) | 7 (14) |
| BOR, n (%) . | Arm A: VEN + R (n = 52) . | Arm A: VEN + R refractory§ (n = 26) . | Arm A: VEN + R nonrefractory§ (n = 26) . |
|---|---|---|---|
| ORR | 19 (37) | 5 (19) | 14 (54) |
| CMR | 13 (25) | 4 (15) | 9 (35) |
| PMR | 6 (12) | 1 (4) | 5 (19) |
| NMR | 6 (12) | 4 (15) | 2 (8) |
| PD | 13 (25) | 6 (23) | 7 (27) |
| Response data missing† | 14 (27) | 11 (42) | 3 (12) |
| BOR, n (%) . | Arm A: VEN + R (n = 52) . | Arm A: VEN + R refractory§ (n = 26) . | Arm A: VEN + R nonrefractory§ (n = 26) . |
|---|---|---|---|
| ORR | 19 (37) | 5 (19) | 14 (54) |
| CMR | 13 (25) | 4 (15) | 9 (35) |
| PMR | 6 (12) | 1 (4) | 5 (19) |
| NMR | 6 (12) | 4 (15) | 2 (8) |
| PD | 13 (25) | 6 (23) | 7 (27) |
| Response data missing† | 14 (27) | 11 (42) | 3 (12) |
NA, not applicable; NMR, no metabolic response; PMR, partial metabolic response; PR, partial response; SD, stable disease.
Primary response evaluated from mid-induction visit to 10 weeks after C6D1 or 10 weeks after day 1 of the last cycle.
Includes off study early for toxicity, off study early for not meeting inclusion/exclusion criteria, off study for death, withdrawal of consent, or unreadable scans. Responses were evaluated by PET/CT scan first; if missing, CT scan response was imputed. All patients with PD prior to or during the observation period were included as PD.
The 12-month responses were evaluated 42 to 65 weeks after C1D1.
Refractoriness to last line of prior treatment was defined as PD within 6 months of last dose received or no responses to treatment (if no PD was reported).