Table 1.
Antiangiogenic therapy plus immune checkpoint blockade clinical trials.
Trial Name/NCT Number | Phase | Drugs | Eligible Patients | Dose/Schedule | Findings of Primary Endpoint(s) | Findings of Secondary Endpoint(s) | Notable common grade AEs (≥10%) |
---|---|---|---|---|---|---|---|
Completed antiangiogenic therapy + ICB trials | |||||||
IMagyn050 NCT03038100 Moore KN, et al. Annals of Oncology (2020). Abstract. |
Randomized, double-blind phase III | SOC plus bevacizumab (bev) plus atezolizumab (atezo) | Newly diagnosed, advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (n = 1301) | Platinum-based chemotherapy (carboplatin plus paclitaxel) for 6 cycles plus bev 15 mg/kg IV for 2–6 cycles plus atezo 1200 mg IV q3w for 6 cycles or placebo Maintenance bev 15 mg/kg IV q3w plus atezo 1200 mg IV q3w for 16 cycles or placebo |
Median PFS in intent-to-treat population: 18.4 mo placebo, vs. 19.5 mo atezo (HR = 0.92, 0.79–1.07) Median PFS in PD-L1± population: 18.5 mo placebo, vs. 20.8 mo atezo (HR = 0.80, 0.65–0.99) |
ORR, duration of response, safety & tolerability | No reported or published data; further analysis pending |
NCT02873962 Liu JF, et al. JAMA Oncol (2019). |
Open-label, single arm phase II | Bevacizumab (bev) plus nivolumab (nivo) | Platinum-sensitive (n = 20) or platinum-resistant (n = 18) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (n = 38) | Bev 10 mg/kg IV q2w plus nivo 240 mg IV q2w | ORR: 28.9% (15.4–45.9) |
ORR by platinum sensitivity: 40.0% (19.1–64.0) platinum-sensitive vs. 16.7% (3.6–41.4) platinum-resistant Median PFS: 9.4 mo (6.7-NA); 12.1 (8.4-NA) platinum-sensitive vs. 7.7 mo (4.7-NA) platinum-resistant |
No grade 3/4 AEs ≥ 10% were observed Hypertension was observed in 26.3% of all patients (5.3% experienced grade 3/4) |
Ongoing/incomplete antiangiogenic therapy + ICB trials | |||||||
ATALANTE NCT02891824 Kurtz JE, et al. Journal of Clinical Oncology (2018). |
Randomized, double-blind, phase III | SOC plus bevacizumab (bev) plus atezolizumab (atezo) | Platinum-sensitive, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (n = 614) | Platinum-based chemotherapy (carboplatin plus gemcitabine/paclitaxel/PLD) plus bev plus placebo (arm A) vs. atezo (arm B) for 6 cycles Maintenance with placebo (arm A) vs. atezo (arm B) until progression |
PFS | TSST, OS, safety & tolerability | No reported or published data |
EORTC-1508 NCT02659384 |
Randomized, triple-blind phase II | Bevacizumab (bev), atezolizumab (atezo), plus acetylsalicylic acid (ASA) | Platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer | Bev alone (arm 1) vs. bev plus atezo plus placebo (arm 2) vs. bev plus atezo plus ASA (arm 3) | PFS | No reported or published data | |
NRG-GY009 NCT02839707 |
Randomized, open-label phase II/III | PLD plus bevacizumab (bev) plus atezolizumab (atezo) | Platinum-resistant recurrent high-grade ovarian, fallopian tube, or primary peritoneal cancer | PLD plus atezo (arm 1) vs. PLD + atezo + bev (arm 2) vs. PLD + bev (arm 3) | PFS (phases II & III) OS (phase UI) |
ORR, PD-Ll expression, safety & tolerability | No reported or published data |
All reported ranges are 95% CI unless otherwise stated
Abbreviations:
AE: adverse event; EORTC: European Organization for Research and Treatment of Cancer; HR: hazards ratio; ICB: immune checkpoint blockade; NA: not applicable; ORR: objective response rate; OS: overall survival; PFS2: second progression-free survival; PLD: pegylated liposomal doxorubicin; SOC: standard of care; TSST: time to second subsequent therapy; mo: months; q2w: once every 2 weeks; q3w: once every 3 weeks