Trial ID # | NCT03699449 |
Phase | II |
Drug Class | Immunotherapy: Checkpoint Inhibitors/PD-L1 |
Drug Name | Durvalumab |
Alternate Drug Names | Anti-B7H1 Monoclonal Antibody MEDI4736, MEDI4736, Imfinzi |
Drugs in Trial | Durvalumab, Olaparib |
Eligible Participant | Platinum resistant ovarian cancer |
Patients Enrolled | Arm B: 14 HRRm Pt-R ovarian cancer, median 4 prior therapies |
Therapy Setting | Recurrence |
Study Design | Open-Label, Non-randomized |
Endpoints | ORR, evaluated per RECIST |
Biomarkers | HRRm panel: ATM, BARD1, BRCA 1/2, BRIP1, CDK12, CHK1/2, FANCL, PALB2, PPP2R2A, RAD51 B/C/D, RAD54L |
Efficacy | ORR: 35.7% (5PR, n=14) - all responders BRCA1/2 MUT |
Conclusion | Durvalumab+olaparib shows promising activity in BRCA MUT patients |
Reference | Lee J-Y et al. An umbrella study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer (KGOG 3045, AMBITION). J Clin Oncol (2021) 39 (suppl 15; abstr 5520) Lee J-Y et al. Poster Lee J-Y et al. Biomarker-guided targeted therapy in platinum-resistant ovarian cancer (AMBITION; KGOG 3045): a multicentre, open-label, five-arm, uncontrolled, umbrella trial. J Gynecol Oncol (2022) 33(4):e45 |