Clinical trials in epithelial OC, EOC

Author Trial/Phase Setting Pts N Treatment Results Grade 3–4 AEs Pts N (%)
Matulonis et al., 2019 [50] KEYNOTE-100
Phase II
Advanced recurrent

Cohort A: 1-3 prior lines PFI/ TFI 3-12 Mo.

Cohort B: 4-6 prior lines PFI/ TFI ≥ 3 Mo.
Cohort A: 285

Cohort B: 91
Pembrolizumab 200 mg q3w until 2 years Total population:
  • ORR 8%, DCR of 37%

Cohort A:
  • ORR 7.4%, DoR 8.2 Mo.

  • DCR 37.2%

  • OS NR

Cohort B:
  • ORR 9.9%

  • DoR NR

  • DCR 37.4%

  • OS 17.6 Mo.

Treatment-related:
  • -fatigue n = 10 (2.7)

  • -anemia n = 5 (1.3)

  • -colitis n = 5 (1.3)

Immune-mediated:
  • -severe skin reactions n = 7 (1.9)

  • -colitis n = 6 (1.6)

SGO 2020 Annual meeting [72] JAVELIN 100
Phase III
First line 998 6 cycles carboplatin AUC 5/6, q3w, + paclitaxel 175 mg/mq q3w or 80 mg/mq weekly
a) + avelumab 10 mg/kg q3w (with CT)/q2w (maintenance)
b) + avelumab 10 mg/kg q2w maintenance
c) no avelumab
ORR:
  • a) 36.0%

  • b) 30.4%

  • c) 30.4%

Grade 3–4 AEs
  • a) 70.8%

  • b) 66.5%

  • c) 62.6%

NCT02580058 [51] JAVELIN 200
Phase III
Platinum resistant 566
  • a) PLD 40 mg/mq q4w

  • b) Ave 10 mg/kg q2w

  • c) combination of both

PFS:
  • a) 3.5 Mo.

  • b) 1.9 Mo.

  • c) 3.7 Mo.

OS:
  • a) 13.1 Mo.

  • b) 11.8 Mo.

  • c) 15.7 Mo.

(HR, 0.89)
Abdominal pain:
  • a) 3.39%

  • b) 4.81%

  • c) 3.30%

Intestinal obstruction:
  • a) 3.39%

  • b) 5.88%

  • c) 4.95%

Vomiting:
  • a) 1.69%

  • b) 3.74%

  • c) 2.20%

Drew et al., 2019 [57] MEDIOLA
Phase II
BRCA-mutated platinum-sensitive relapsed 32 Olaparib monotherapy 300 mg bid 4 weeks → olaparib 300 mg bid + durvalumab 1,500 mg IV q4w ORR 71.9%

28-wk DCR 65.6%

Median PFS 11.1 Mo.

Median DoR 10.2 Mo.
-anaemia 17.6%
-elevated lipase 11.8%
-neutropenia 8.8%
-lymphopenia 8.8%

Discontinuation due to AEs:
  • Olaparib 5 pts

  • Durvalumab 3 pts

Konstantinopoulos et al., 2019 [58] TOPACIO
Phase I-II
Recurrent platinum-resistant 60 Niraparib 200 mg daily + pembrolizumab 200 mg q3w ORR 18%

DCR 65%
Treatment-related:
  • -anemia n = 11 (21)

  • -thrombocytopenia n = 5 (9)

  • -leukopenia n = 3 (6)

  • -neutropenia n = 2 (4)

Immune-related AEs:
  • n = 3 (6)

Pts N: patient number; Mo.: month; NR not reached