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Fuzuloparib with or without apatinib in HER2- metastatic breast cancer (mBC) patients (pts) with germline BRCA1/2 mutations (gBRCA1/2m): A randomized phase III trial

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VP2-2024: Fuzuloparib with or without apatinib in HER2- metastatic breast cancer (mBC) patients (pts) with germline BRCA1/2 mutations (gBRCA1/2m): A randomized phase III trial

Published: May 9, 2024

DOI: https://doi.org/10.1016/j.annonc.2024.04.003
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H. Li, J. Liu, Y. Liu, ..., E. Song
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Fuzuloparib is an oral poly (ADP–ribose) polymerase inhibitor (PARPi) that has promising antitumor activity in pts with BRCAm. The combination of an anti-angiogenic agent with a PARPi improved clinical outcomes in gynecological cancers. Here we assessed fuzuloparib with or without apatinib, a VEGFR2 inhibitor, for treating HER2- mBC pts with gBRCA1/2m.


In this randomized, open-label, phase 3 trial, pts were assigned (1:1:1) to receive fuzuloparib (100 mg po bid) with apatinib (500 mg po qd), fuzuloparib (150 mg po bid), or standard chemo of the physician’s choice (capecitabine or gemcitabine in continuous 21-day cycles). The primary endpoint was PFS per blinded independent central review. 


Of the randomized 203 pts, 70 were assigned to receive fuzuloparib + apatinib, 67 to fuzuloparib alone, and 66 to standard chemo. Compared with standard chemo, PFS was significantly prolonged with fuzuloparib + apatinib (median, 11.0 vs. 3.0 mo; HR, 0.27 [95% CI, 0.17-0.43]; P<0.0001) or fuzuloparib (median, 6.7 vs. 3.0 mo; HR, 0.49 [0.32-0.75]; P=0.0004). Additionally, fuzuloparib + apatinib was superior to fuzuloparib in PFS (HR, 0.60 [0.40-0.91]; P=0.0079; Table). Of note, both fuzuloparib + apatinib and fuzuloparib had longer median OS than standard chemo (29.2 and 31.5 vs. 21.5 mo; HR, 0.58 [0.33-1.02] and 0.61 [0.35-1.08]). Grade ≥3 AEs occurred in 58.6%, 58.2%, and 44.1% of pts with fuzuloparib + apatinib, fuzuloparib, and standard chemo, and AEs led to treatment discontinuation in 7.1%, 0, and 7.7% of pts, respectively.

Table. Efficacy summary


Fuzuloparib + Apatinib (N=70) 

Fuzuloparib (N=67) 

Standard Chemo (N=66) 





Events, n (%) 

46 (65.7%) 

50 (74.6%) 

45 (68.2%) 

Median (95% CI), mo 

11.0 (8.4-13.1) 

6.7 (4.2-7.6) 

3.0 (1.6-5.3) 

Comparison vs. standard chemo, HR (95% CI); P 

0.27 (0.17-0.43); P<0.0001 

0.49 (0.32-0.75); P=0.0004 


Comparison vs. fuzuloparib, HR (95% CI); P 

0.60 (0.40-0.91); P=0.0079 



ORR, % (n/N*) 

67.3% (35/52) 

43.6% (24/55) 

23.3% (10/43) 





Events, n (%) 

25 (35.7%) 

23 (34.3%) 

26 (39.4%) 

Median (95% CI), mo 

29.2 (24.6-NR) 

31.5 (17.8-NR) 

21.5 (15.6-31.9) 

Comparison vs. standard chemo, HR (95% CI) 

0.58 (0.33-1.02) 

0.61 (0.35-1.08) 


*assessed in pts with baseline measurable target lesions. 


For pts with HER2- mBC and a gBRCAm, fuzuloparib alone or plus apatinib provided significantly prolonged PFS compared with standard chemo, with an acceptable safety profile. The combination of apatinib showed superior PFS benefit over PARPi alone. Fuzuloparib alone or plus apatinib demonstrated a trend towards improved OS than standard chemo.

Clinical trial identification

NCT04296370. Release date: March 5, 2020.

Legal entity responsible for the study: Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Funding: Jiangsu Hengrui Pharmaceuticals Co., Ltd.

J. Nie: Financial Interests, Personal, Research Grant: Hengrui, Sanofi, Qilu, Junshi, Zhengdatianqing, Boan, Maiwei, Novartis, Xuanzhu. 
Y. Wang and X. Yang: Financial Interests, Personal, Full or part-time Employment: Hengrui. 
All other authors have declared no conflicts of interest.

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