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

Trial ID # NCT01846611; OVC-3006
Phase III
Drug Class Chemotherapy
Drug Name Trabectedin
Alternate Drug Names Yondelis, ET-743
Drugs in Trial Liposomal doxorubicin, Trabectedin
Eligible Participant

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

Patients Enrolled

576

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

PFS, OS, evaluated per RECIST

Biomarkers

Exploratory: gBRCA MUT, Pt-status

Efficacy

Tra+PLD (n=289) vs PLD (n=287):
PFS: 7.5 vs 7.3 months, HR: 0.935 (0.762-1.147, p=0.5174)
OS: 23.2 vs 22.2 months, HR: 0.93 (0.73-1.18, p=0.5236)

Exploratory analysis gBRCA-status, Pt-status:
Tra+PLD vs PLD:
gBRCA MUT (n=155):
PFS: 10.1 vs 7.6 months, HR: 0.722 (0.484-1.078, p=0.108)
OS: 34.2 vs 20.9 months, HR: 0.542 (0.327-0.901, p=0.0165)
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: 0.374 (0.171-0.819, p=0.0108)

Clinically Significant Adverse Events

Tra+PLD vs PLD:
Serious AE: overall (41.3 vs 20.6%)
Grade 3-4 AE: overall (85.0 vs 63.8%)

Conclusion

Trabectedin+liposomal doxorubicin shows antitumor activity in gBRCA MUT patients

Reference

Monk BJ et al. A randomized, open-label study comparing trabectedin and pegylated liposomal doxorubicin with pegylated liposomal doxorubicin alone for the treatment of advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (ET743-OVC-3006). SGO (2019) Abstract 20
https://www.medpagetoday.com/meetingcoverage/sgo/78666