A Randomized Placebo-Controlled Phase II Trial Comparing Gemcitabine Monotherapy to Gemcitabine in Combination With AZD 1775 (MK 1775) in Women With Recurrent, Platinum Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers

Trial ID # NCT02101775
Phase II
Drug Class Cell Cycle Inhibitors: Wee1
Drug Name Adavosertib
Alternate Drug Names WEE1 inhibitor AZD1775, MK1775, AZD1775
Drugs in Trial Adavosertib, Gemcitabine
Eligible Participant

Platinum-resistant ovarian cancer

Patients Enrolled

125 [Gem+Ada, n=65, median 3 prior therapies (1-8); Gem: n=34, median 3 prior therapies (1-9); Gem+Ada for non HGS histologies, n=25]

Therapy Setting

Recurrence

Study Design

Double Blind, Randomized

Endpoints

ORR, DCR, PFS, OS, evaluated per RECIST

Efficacy

Gem+Ada (n=65) vs Gem (n=34):

ORR: 25 (14PR, n=57) vs 7% (2PR, n=30) (read from poster)
DCR: 93 (14PR, 39SD, n=57) vs 90% (2PR, 25SD, n=30) (read from poster)
PFS: 4.6 vs 3 months, HR: 0.55 (0.35-0.90, p=0.015)
OS: 11.4 vs 7.2 months, HR: 0.56 (0.35-0.91, p=0.017)

Clinically Significant Adverse Events

Gem+Ada vs Gem:
Serious AE:
Grade 3-4AE: anemia (31 vs 21%), thrombocytopenia (31 vs 6%), fatigue (16 vs 9%)

Conclusion

Addition of adavosertib to gemzar improves ORR, PFS and OS in platinum-resistant patients

Reference

Lheurheux S et al. A randomized double-blind placebo-controlled phase II trial comparing gemcitabine monotherapy to gemcitabine in combination with adavosertib in women with recurrent, platinum resistant epithelial ovarian cancer: A trial of the Princess Margaret, California, Chicago and Mayo Phase II Consortia. J Clin Oncol (2019) 37(suppl; abstr 5518)
https://meetinglibrary.asco.org/record/173474/abstract