An Open Label, Multi-Center Phase I/II Study to Evaluate Efficacy and Safety of BGB-290 in Chinese Subjects With Advanced Ovarian Cancer, Fallopian Cancer, and Primary Peritoneal Cancer or Advanced Triple Negative Breast Cancer

Trial ID # NCT03333915
Phase I/II
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Pamiparib
Alternate Drug Names PARP inhibitor BGB-290
Drugs in Trial Pamiparib
Eligible Participant

Recurrent gBRCA MUT ovarian cancer with ≥ 2 prior therapies with no prior PARP inhibitor

Patients Enrolled

113; 90 Pt-S, median 2 prior therapies; 23 Pt-R, median 3 prior therapies

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

CBR, ORR, DCR, DoR, PFS, OS, evaluated per RECIST

Biomarkers

gBRCA status

Efficacy

Pt-S:
ORR: 64.6% (8CR, 45PR, n=82)
DCR: 95.1% (8CR, 45PR, 25SD, n=82)
CBR: 74.4%
DoR: 14.5 months
PFS: 15.2 months

Pt-R:
ORR: 31.6% (6PR, n=19)
DCR: 94.7% (6PR, 12SD, n=19)
CBR: 52.6%
DoR: 11.1 months
PFS: 6.2 months
OS: 13.6 months

Clinically Significant Adverse Events

Serious AE: Pt-S: overall (37.8%), Pt-R: overall (65.2%)
Grade 3-4 AE: Pt-S: overall (67.8%), anemia (37.8%), decreased neutrophil counts (31.1%), decreased white blood cell counts (18.9%), leukopenia (10%); Pt-R: overall (82.6%), anemia (56.5%), decreased neutrophil counts (43.5%), decreased white blood cell counts (21.7%), leukopenia (13%)

Conclusion

Pamiparib showes antitumor activity with durable responses in patients with gBRCA MUT platinum sensitive or platinum resistant ovarian cancer and has a manageable safety profile

Reference

Wu X et al. Pamiparib Monotherapy for Patients With Germline BRCA1/2-Mutated Ovarian Cancer Previously Treated With at Least Two Lines of Chemotherapy: A Multicenter, Open-Label, Phase II Study. Clin Cancer Res (2021)
https://pubmed.ncbi.nlm.nih.gov/34844979/

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