Summary of efficacy outcomes
| Outcome . | Randomized cohorts . | Extension cohort, pola + BR (n = 106) . | |
|---|---|---|---|
| BR (n = 40) . | pola + BR (n = 40) . | ||
| EOT response, n (%) | |||
| IRC-assessed ORR | 7 (17.5) | 17 (42.5) | 44 (41.5) |
| CR | 7 (17.5) | 17 (42.5) | 41 (38.7) |
| PR | 0 | 0 | 3 (2.8) |
| SD | 1 (2.5) | 6 (15.0) | 4 (3.8) |
| PD | 6 (15.0) | 8 (20.0) | 19 (17.9) |
| Missing/NE | 26 (65.0) | 9 (22.5) | 39 (36.8) |
| INV-assessed ORR | 7 (17.5) | 19 (47.5) | 45 (42.5) |
| CR | 6 (15.0) | 17 (42.5) | 39 (36.8) |
| PR | 1 (2.5) | 2 (5.0) | 6 (5.7) |
| SD | 0 | 1 (2.5) | 1 (0.9) |
| PD | 27 (67.5) | 13 (32.5) | 40 (37.7) |
| Missing/NE | 6 (15.0) | 7 (17.5) | 20 (18.9) |
| Best responses, n (%) | |||
| ORR (IRC) | 10 (25.0) | 25 (62.5) | 60 (56.6) |
| CR | 9 (22.5) | 21 (52.5) | 56 (52.8) |
| PR | 1 (2.5) | 4 (10.0) | 4 (3.8) |
| SD | 9 (22.5) | 5 (12.5) | 17 (16.0) |
| PD | 8 (20.0) | 6 (15.0) | 17 (16.0) |
| Missing/NE | 13 (32.5) | 4 (10.0) | 12 (11.3) |
| ORR (INV) | 13 (32.5) | 28 (70.0) | 66 (62.3) |
| CR | 8 (20.0) | 23 (57.5) | 53 (50.0) |
| PR | 5 (12.5) | 5 (12.5) | 13 (12.3) |
| SD | 2 (5.0) | 1 (2.5) | 7 (6.6) |
| PD | 22 (55.0) | 7 (17.5) | 29 (27.4) |
| Missing/NE | 3 (7.5) | 4 (10.0) | 4 (3.8) |
| Median DOR, mo (95% CI) | |||
| IRC-assessed | 10.6 (4.0-19.6) | 10.9 (5.7-40.7) | 9.5 (7.9-12.1) |
| INV-assessed | 4.1 (2.6-12.7) | 12.7 (5.8-27.9) | 8.7 (5.9-12.1) |
| Median PFS, mo (95% CI) | |||
| IRC-assessed | 3.7 (2.1-4.5) | 9.2 (6.0-13.9) | 6.6 (5.1-9.2) |
| INV-assessed | 2.0 (1.5-3.7) | 7.5 (4.9-17.0) | 5.9 (4.8-7.5) |
| 24-mo PFS probability, % (95% CI) | |||
| IRC-assessed | 9.1 (0.0-18.9) | 28.4 (13.8-43.0) | — |
| Median OS, months (95% CI) | 4.7 (3.7-8.3) | 12.4 (9.0-32.0) | 12.5 (8.3-23.1) |
| Outcome . | Randomized cohorts . | Extension cohort, pola + BR (n = 106) . | |
|---|---|---|---|
| BR (n = 40) . | pola + BR (n = 40) . | ||
| EOT response, n (%) | |||
| IRC-assessed ORR | 7 (17.5) | 17 (42.5) | 44 (41.5) |
| CR | 7 (17.5) | 17 (42.5) | 41 (38.7) |
| PR | 0 | 0 | 3 (2.8) |
| SD | 1 (2.5) | 6 (15.0) | 4 (3.8) |
| PD | 6 (15.0) | 8 (20.0) | 19 (17.9) |
| Missing/NE | 26 (65.0) | 9 (22.5) | 39 (36.8) |
| INV-assessed ORR | 7 (17.5) | 19 (47.5) | 45 (42.5) |
| CR | 6 (15.0) | 17 (42.5) | 39 (36.8) |
| PR | 1 (2.5) | 2 (5.0) | 6 (5.7) |
| SD | 0 | 1 (2.5) | 1 (0.9) |
| PD | 27 (67.5) | 13 (32.5) | 40 (37.7) |
| Missing/NE | 6 (15.0) | 7 (17.5) | 20 (18.9) |
| Best responses, n (%) | |||
| ORR (IRC) | 10 (25.0) | 25 (62.5) | 60 (56.6) |
| CR | 9 (22.5) | 21 (52.5) | 56 (52.8) |
| PR | 1 (2.5) | 4 (10.0) | 4 (3.8) |
| SD | 9 (22.5) | 5 (12.5) | 17 (16.0) |
| PD | 8 (20.0) | 6 (15.0) | 17 (16.0) |
| Missing/NE | 13 (32.5) | 4 (10.0) | 12 (11.3) |
| ORR (INV) | 13 (32.5) | 28 (70.0) | 66 (62.3) |
| CR | 8 (20.0) | 23 (57.5) | 53 (50.0) |
| PR | 5 (12.5) | 5 (12.5) | 13 (12.3) |
| SD | 2 (5.0) | 1 (2.5) | 7 (6.6) |
| PD | 22 (55.0) | 7 (17.5) | 29 (27.4) |
| Missing/NE | 3 (7.5) | 4 (10.0) | 4 (3.8) |
| Median DOR, mo (95% CI) | |||
| IRC-assessed | 10.6 (4.0-19.6) | 10.9 (5.7-40.7) | 9.5 (7.9-12.1) |
| INV-assessed | 4.1 (2.6-12.7) | 12.7 (5.8-27.9) | 8.7 (5.9-12.1) |
| Median PFS, mo (95% CI) | |||
| IRC-assessed | 3.7 (2.1-4.5) | 9.2 (6.0-13.9) | 6.6 (5.1-9.2) |
| INV-assessed | 2.0 (1.5-3.7) | 7.5 (4.9-17.0) | 5.9 (4.8-7.5) |
| 24-mo PFS probability, % (95% CI) | |||
| IRC-assessed | 9.1 (0.0-18.9) | 28.4 (13.8-43.0) | — |
| Median OS, months (95% CI) | 4.7 (3.7-8.3) | 12.4 (9.0-32.0) | 12.5 (8.3-23.1) |
BR, bendamustine-rituximab; CI, confidence interval; CR, complete response; DOR, duration of response; EOT, end of treatment; INV, investigator; IRC, Independent Review Committee; NE, not evaluable; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; pola, polatuzumab vedotin; PR, partial response; SD, stable disease.