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VP5-2023: Primary results from BEATcc (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030), a randomised phase III trial of first-line atezolizumab (atezo) combined with a platinum doublet and bevacizumab (bev) for metastatic (stage IVB), persistent or recurrent cervical cancer (R/M CC)
Published: November 3, 2023
DOI: 10.1016/j.annonc.2023.10.694
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A. Oaknin, L. Gladieff, J. Martinez-Garcia... L. Randall
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Background
The open-label randomised phase 3 BEATcc academic trial (NCT03556839) evaluated atezo (anti-PD-L1) combined with first-line chemotherapy (CT) + bev for R/M CC, irrespective of PD-L1 status. We report final progression-free survival (PFS) and interim overall survival (OS) results.
Methods
Patients (pts) with previously untreated measurable R/M CC not amenable to curative surgery/radiation were randomised 1:1 to standard therapy (cisplatin 50 mg/m2 or carboplatin AUC5 + paclitaxel 175 mg/m2 + bev 15 mg/kg) ± atezo 1200 mg d1 q3w. Cycles were repeated until disease progression or unacceptable toxicity. Stratification factors were prior concomitant chemoradiation (yes vs no), histology (squamous cell carcinoma vs adenocarcinoma) and platinum agent (cisplatin vs carboplatin). Dual primary endpoints were investigator-assessed PFS per RECIST v1.1 and OS. Secondary endpoints included objective response rate (ORR), duration of response (DoR), time to first subsequent therapy (TFST), PFS2, and safety.
Results
Between Oct 2018 and Aug 2021, 410 pts were randomised. At the data cut-off (median follow-up 32.9 mo), median treatment duration was 8.5 vs 12.7 mo in the control vs atezo arms, respectively; treatment was ongoing in 7% vs 23%, respectively. Both PFS and OS were statistically significantly improved with the addition of atezo to CT + bev (Table). Secondary endpoints and subgroup analyses showed consistent results. Grade ≥3 adverse events (any cause) occurred in 75% vs 79% of the control and atezo arms, respectively. Safety profiles were as expected with bev + platinum-based CT. Grade 1/2 diarrhoea, arthralgia, pyrexia and rash were increased with atezo.
Endpoint |
CT + bev (n=204) |
Atezo + CT + bev (n=206) |
|
PFS |
Events, n (%) |
166 (81) |
138 (67) |
HR |
0.62 (0.49–0.78); p<0.0001 |
||
Median, mo |
10.4 (9.7–11.7) |
13.7 (12.3–16.6) |
|
2-year rate, % |
19 (14–25) |
36 (29–43) |
|
OS |
Events, n (%) |
129 (63) |
105 (51) |
HR |
0.68 (0.52–0.88); p=0.0046* |
||
Median, mo |
22.8 (20.3–28.0) |
32.1 (25.3–36.8) |
|
2-year rate, % |
49 (41–56) |
61 (53–67) |
|
TFST |
Median, mo |
13.2 (12.0–14.3) |
19.0 (16.4–24.0) |
HR |
0.60 (0.47–0.76) |
||
PFS2 |
Median, mo |
20.3 (17.8–22.3) |
25.8 (22.1–32.1) |
HR |
0.61 (0.48–0.79) |
||
ORR per RECIST v1.1, % |
72 (66–78) |
84 (79–89) |
|
DoR |
n |
147 |
173 |
Median, mo |
8.6 (8.0–10.6) |
13.6 (10.6–21.3) |
|
HR |
0.60 (0.46–0.78) |
||
Brackets show 95% CIs unless otherwise stated HR = hazard ratio *Statistically significant at interim analysis | |||
Conclusions
Adding atezo to first-line CT + bev for R/M CC significantly improved all efficacy outcomes. Median OS with atezo + CT + bev exceeded 2.5 years.
Clinical trial identification
NCT03556839; EudraCT 2018-000367-83; ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030/BEATcc.
