Table 2 Overview of safety.

From: PARP inhibition with rucaparib alone followed by combination with atezolizumab: Phase Ib COUPLET clinical study in advanced gynaecological and triple-negative breast cancers

Patients, n (%)

Part 1 (dose finding)

Part 2 (dose expansion)

Cohort 1 (n = 3)

Cohort 2 (n = 6)

Ovarian cancer, Arms A + B (n = 14)

TNBC, Arm C (n = 5)

Run-in

Post run-in

Run-in

Post run-in

Any grade AE

3 (100)

6 (100)

12 (86)

14 (100)

5 (100)

5 (100)

    Grade 3/4

1 (33)

4 (67)

4 (29)

10 (71)

2 (40)

1 (20)

    Grade 5

0

0

0

0

0

0

Treatment-related AE

3 (100)

6 (100)

12 (86)

12 (86)

4 (80)

3 (60)

AE leading to treatment discontinuation

0

1 (17)a

0

2 (14)b

0

0

AE leading to treatment modification/interruption

3 (100)

4 (67)

3 (21)

8 (57)

1 (20)

1 (20)

    Atezolizumab

1 (33)

1 (17)

0

5 (36)

0

1 (20)

    Rucaparib

3 (100)

4 (67)

3 (21)

8 (57)

1 (20)

1 (20)

  1. AE adverse event, TNBC triple-negative breast cancer.
  2. aAtezolizumab was discontinued because of non-serious grade 1/2 diarrhoea starting on Day 72.
  3. bArm A, 1 patient discontinued rucaparib because of persistent grade 2/3 neutropenia starting on Day 253 and atezolizumab because of grade 2 pericarditis starting on Day 310; 1 patient discontinued atezolizumab and rucaparib because of serious grade 3 acute kidney injury and grade 4 bone marrow failure with non-serious grade 2/3 anaemia and grade 1–3 decreased platelet count, all starting on Day 63.
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