A Randomized, Phase II Study Evaluating MK-1775 in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Adult Patients With Platinum Sensitive p53 Mutant Ovarian Cancer

Trial ID #	NCT01357161
Phase	II
Drug Class	Cell Cycle Inhibitors: Wee1
Drug Name	Adavosertib
Alternate Drug Names	WEE1 inhibitor AZD1775, MK1775, AZD1775
Drugs in Trial	Adavosertib, Carboplatin, Paclitaxel
Eligible Participant	Platinum sensitive, TP53-mutated ovarian cancer
Patients Enrolled	121
Therapy Setting	Recurrence
Study Design	Double Blind, Randomized
Endpoints	ORR, PFS, OS, evaluated per RECIST
Biomarkers	TP53 MUT
Efficacy	Ada+CarboPt+Pac vs CarboPt+Pac: ORR: 81.4 vs 75.8% (p=0.46) PFS: 7.9 vs 7.3 months, HR: 0.63 (0.38-1.06, p=0.080) OS: data immature (interim analysis, 57% maturity)
Clinically Significant Adverse Events	Ada+CarboPt+Pac vs CarboPt+Pac: Serious AE: 40.7 vs 20% Grade 3-4 AE: 78 vs 65%
Conclusion	Improved PFS with addition of AZD1775
Reference	Oza A et al. A Biomarker-Enriched, Randomized Phase II Trial of Adavosertib (AZD1775) Plus Paclitaxel and Carboplatin for Women With Platinum-Sensitive TP53-mutant Ovarian Cancer. Clin Cancer Res (2020) 26(18):4767-4776 https://pubmed.ncbi.nlm.nih.gov/32611648/