Preferred term, n (%) | Part A DOS+NIR | Part B DOS+C–P | Part C DOS+NIR+BEV | Part D DOS+C–P+BEV | ||||
Niraparib 200 mg QD (n=16) | Niraparib 300 mg QD (n=6) | Overall (n=22) | Overall (n=14) | Niraparib 200 mg QD (n=6) | Niraparib 300 mg QD (n=7) | Overall (n=13) | Overall (n=6) | |
Any-grade TEAEs* | 16 (100) | 6 (100) | 22 (100) | 14 (100) | 6 (100) | 7 (100) | 13 (100) | 6 (100) |
Nausea | 8 (50) | 4 (67) | 12 (55) | 4 (29) | 3 (50) | 4 (57) | 7 (54) | 3 (50) |
Anemia | 4 (25) | 3 (50) | 7 (32) | 10 (71) | 2 (33) | 5 (71) | 7 (54) | 5 (83) |
Fatigue | 4 (25) | 3 (50) | 7 (32) | 7 (50) | 2 (33) | 4 (57) | 6 (46) | 4 (67) |
Vomiting | 5 (31) | 2 (33) | 7 (32) | 2 (14) | 1 (17) | 4 (57) | 5 (39) | 2 (33) |
Cough | 4 (25) | 3 (50) | 7 (32) | 3 (21) | 1 (17) | 2 (29) | 3 (23) | 2 (33) |
Dyspnea | 5 (31) | 1 (17) | 6 (27) | 7 (50) | 2 (33) | 3 (43) | 5 (39) | 3 (50) |
Thrombocytopenia | 5 (31) | 2 (33) | 6 (27) | 2 (14) | 2 (33) | 2 (29) | 4 (31) | 2 (33) |
Constipation | 5 (31) | 2 (33) | 7 (32) | 4 (29) | 4 (67) | 4 (57) | 8 (62) | 3 (50) |
Headache | 3 (19) | 1 (17) | 4 (18) | 3 (21) | 4 (67) | 1 (14) | 5 (39) | 1 (17) |
Alopecia | 0 | 0 | 0 | 8 (57) | 0 | 1 (14) | 1 (8) | 5 (83) |
Decreased appetite | 2 (13) | 0 | 2 (9) | 6 (43) | 0 | 3 (43) | 3 (23) | 1 (17) |
Neutropenia | 1 (6) | 1 (17) | 2 (9) | 6 (43) | 1 (17) | 1 (14) | 2 (15) | 4 (67) |
Diarrhea | 0 | 0 | 0 | 6 (43) | 2 (33) | 4 (57) | 6 (46) | 4 (67) |
Weight decrease | 4 (25) | 1 (17) | 5 (23) | 1 (7) | 1 (17) | 2 (29) | 3 (23) | 3 (50) |
Grade ≥3 TEAEs† | 12 (75) | 5 (83) | 17 (77) | 10 (71) | 5 (83) | 7 (100) | 12 (92) | 6 (100) |
Thrombocytopenia | 2 (13) | 1 (17) | 3 (14) | 0 | 1 (17) | 1 (14) | 2 (15) | 2 (33) |
Anemia | 3 (19) | 0 | 3 (14) | 3 (21) | 1 (17) | 2 (29) | 3 (23) | 0 |
Neutropenia | 1 (6) | 1 (17) | 2 (9) | 4 (29) | 0 | 1 (14) | 1 (8) | 3 (50) |
Pneumonia | 1 (6) | 1 (17) | 2 (9) | 0 | 1 (17) | 0 | 1 (8) | 0 |
ALT increase | 1 (6) | 0 | 1 (5) | 2 (14) | 0 | 1 (14) | 1 (8) | 0 |
AST increase | 1 (6) | 0 | 1 (5) | 2 (14) | 0 | 1 (14) | 1 (8) | 0 |
Asthenia | 0 | 1 (17) | 1 (5) | 2 (14) | 0 | 0 | 0 | 0 |
Fatigue | 0 | 1 (17) | 1 (5) | 3 (21) | 0 | 0 | 0 | 1 (17) |
Vomiting | 0 | 0 | 0 | 1 (7) | 0 | 0 | 0 | 0 |
Dose-limiting toxicity‡ | 2 (13) | 0 | 2 (9) | 1 (7) | 1 (17) | 1 (14) | 2 (15) | 0 |
AST increase | 0 | 0 | 0 | 1 (7) | 0 | 0 | 0 | 0 |
Vertebral artery dissection | 0 | 0 | 0 | 0 | 1 (17) | 0 | 1 (7) | 0 |
Hypertension | 1 (6) | 0 | 1 (5) | 0 | 0 | 0 | 0 | 0 |
Mucosal inflammation | 1 (6) | 0 | 1 (5) | 0 | 0 | 0 | 0 | 0 |
Neutrophil count decreased§ | 0 | 0 | 0 | 0 | 0 | 1 (14) | 1 (7) | 0 |
TEAE leading to treatment discontinuation | 3 (19) | 1 (17) | 4 (18) | 4 (29) | 2 (33) | 1 (14) | 3 (23) | 1 (17) |
*Any-grade TEAEs are listed for AEs that occurred in >25% of patients overall in any part.
†Grade ≥3 TEAEs and SAEs are listed for AEs that occurred in ≥2 patients overall in any part.
‡DLTs were grade 3 unless otherwise noted.
§Grade 4.
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BEV, bevacizumab; C–P, carboplatin–paclitaxel; DLT, dose-limiting toxicitie ; DOS, dostarlimab; NIR, niraparib; QD, once daily; SAE, serious adverse event; TEAE, treatment-emergent adverse event.