A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK 1120212) in Patients With Recurrent or Progressive Low-Grade Serous Ovarian Cancer or Peritoneal Cancer

Trial ID # NCT02101788
Phase III
Drug Class Signaling Pathway Inhibitors: RAS-RAF-MEK-ERK/MEK
Drug Name Trametinib
Alternate Drug Names Mekinist, MEK Inhibitor GSK1120212, JTP-74057, GSK1120212, TMT212
Drugs in Trial Letrozole, Liposomal doxorubicin, Paclitaxel, Tamoxifen, Topotecan, Trametinib
Eligible Participant

Recurrent low grade serous ovarian cancer

Patients Enrolled

260; median 3 prior therapies

Therapy Setting

Recurrence

Study Design

Double Blind, Randomized

Endpoints

ORR, DoR, PFS, OS, evaluated per RECIST

Efficacy

Tra vs Standard of Care Treatment of Physician's Choice (TPC) (Let, Pac, PLD, Tam or Top):

ORR: 26.2 vs 6.2% (p<0.0001)
PFS: 13.0 vs 7.2  months, HR 0.48 (0.36-0.64, p<0.0001)
DoR: 13.6  vs 5.9 months
OS: 37.0  vs 29.2  months, HR 0.75 (0.51-1.11)

Clinically Significant Adverse Events

Tra vs TPC:
Serious AE: none
Grade 3-4 AE: hematologic toxicity (13.4 vs 9.4%), skin toxicity (15 vs 3.9%) vascular toxicity (18.9 vs 8.6%)

Conclusion

In low grade serous ovarian cancer trametinib therapy was associated with significantly improved ORR and PFS compared to standard of care

Reference

Gershenson GM et al. A randomized phase II/III study to assess the efficacy of trametinib in patients with recurrent or progressive low-grade serous ovarian or peritoneal cancer. ESMO (2019) Abstr LBA61
https://oncologypro.esmo.org/meeting-resources/esmo-2019-congress/A-Randomized-Phase-II-III-Study-to-Assess-the-Efficacy-of-Trametinib-in-Patients-with-Recurrent-or-Progressive-Low-Grade-Serous-Ovarian-or-Peritoneal-Cancer