A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Platinum sensitive ovarian cancer with ≤ 2 prior platinum-based therapies

576

Recurrence

Open-Label, Randomized

PFS, OS, evaluated per RECIST

Exploratory: gBRCA MUT, Pt-status

Tra+PLD (n=289) vs PLD (n=287):
ORR: 46 vs 35.9% (p=0.01)
PFS: 7.52 vs 7.26 months, HR: 0.93 (0.76-1.15, p=0.52)
OS: 23.8 vs 22.2 months, HR: 0.92 (0.73-1.18, p=0.52)

Exploratory analysis gBRCA-status, Pt-status:
Tra+PLD vs PLD:
gBRCA MUT (n=155):
PFS: 10.1 vs 7.6 months, HR: 0.72 (0.48-1.08, p=0.108)
OS: 34.2 vs 20.9 months, HR: 0.54 (0.33-0.90, p=0.016)
Part Pt-S (n=224):
PFS: 7.5 vs 5.5 months, HR: 0.715 (0.519-0.986, p=0.0388)
OS: 24.8 vs 17.4 months, HR: 0.694 (0.476-1.012, p=0.0565)
gBRCA MUT and Part Pt-S (n=60):
PFS: 10.1 vs 6.1 months, HR: 0.472 (0.255-0.875, p=0.0143)
OS: 31.5 vs 14.9 months, HR: 0.37 (0.17-0.82, p=0.011)

Tra+PLD vs PLD:
Serious AE: overall (41.3 vs 20.6%)
Grade 3-4 AE: overall (79 vs 54%)

Trabectedin+liposomal doxorubicin shows antitumor activity in gBRCA MUT patients

Monk BJ et al. A phase 3 randomized, open-label, multicenter trial for safety and efficacy of combined trabectedin and pegylated liposomal doxorubicin therapy for recurrent ovarian cancer. Gynecol Oncol (2020)156(3):535-544
https://pubmed.ncbi.nlm.nih.gov/31924332/