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BEATcc

Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent or recurrent cervical cancer (BEATcc, ENGOT-Cx10-GEICO 68-C-JGOG1084-GOG-3030)

Phase 3N = 410NCT03556839

Population
Metastatic (stage IVB), persistent or recurrent cervical cancer, measurable, previously untreated for advanced disease and not amenable to curative surgery or radiation; 410 of 519 patients assessed were enrolled between October 2018 and August 2021
Design
Investigator-initiated, randomised (1:1), open-label phase 3 trial at 92 sites in Europe, Japan and the USA: cisplatin 50 mg/m2 or carboplatin AUC 5, paclitaxel 175 mg/m2 and bevacizumab 15 mg/kg on day 1 of each 3-week cycle, with or without atezolizumab 1200 mg. Stratified by previous concomitant chemoradiation, histology and platinum backbone. Dual primary endpoints: investigator-assessed PFS per RECIST v1.1 and OS (ITT population).
Primary endpoint
PFS, OS
Arms
  • Atezolizumab plus bevacizumab and chemotherapy (experimental): Platinum (cisplatin or carboplatin), paclitaxel and bevacizumab plus atezolizumab 1200 mg every 3 weeks
  • Bevacizumab and chemotherapy (control): Platinum (cisplatin or carboplatin), paclitaxel and bevacizumab every 3 weeks
People
Oaknin A, senior author ENGOT-Cx10-GEICO 68-C-JGOG1084-GOG-3030 Investigators, ENGOT-Cx10-GEICO 68-C-JGOG1084-GOG-3030 Investigators
PFSHR 0.62 (95% CI 0.49–0.78)Δ median PFS+3.3 monthsOSHR 0.68 (95% CI 0.52–0.88)Δ median OS+9.3 months
Show the numbers
Results reported for BEATcc
EndpointAnalysisAtezolizumab plus bevacizumab and chemotherapyBevacizumab and chemotherapyEffect
PFSEnrolled patients (N = 410)primaryOaknin 2024median 13.7 months (12.3–16.6)median 10.4 months (9.7–11.7)HR 0.62 (95% CI 0.49–0.78)P<0.0001Investigator-assessed PFS per RECIST v1.1.
OSinterimOaknin 2024median 32.1 months (25.3–36.8)median 22.8 months (20.3–28.0)HR 0.68 (95% CI 0.52–0.88)P=0.0046Interim overall-survival analysis. The abstract states that overall survival was analysed in the intention-to-treat population.
Results reported for BEATcc
EndpointAnalysisAtezolizumab plus bevacizumab and chemotherapyBevacizumab and chemotherapyEffect
PFSEnrolled patients (N = 410)primaryOaknin 2024median 13.7 months (12.3–16.6)median 10.4 months (9.7–11.7)HR 0.62 (95% CI 0.49–0.78)P<0.0001Investigator-assessed PFS per RECIST v1.1.
OSinterimOaknin 2024median 32.1 months (25.3–36.8)median 22.8 months (20.3–28.0)HR 0.68 (95% CI 0.52–0.88)P=0.0046Interim overall-survival analysis. The abstract states that overall survival was analysed in the intention-to-treat population.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.620.49–0.78
OS0.680.52–0.88
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015202530Months (modelled)
  • Atezolizumab plus bevacizumab and chemotherapy (experimental)
  • Bevacizumab and chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAtezolizumab plus bevacizumab and chemotherapyBevacizumab and chemotherapy
0100.0%100.0%
963.4%54.9%
1742.3%32.2%
2626.8%17.7%
3417.9%10.4%
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%020406080Months (modelled)
  • Atezolizumab plus bevacizumab and chemotherapy (experimental)
  • Bevacizumab and chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAtezolizumab plus bevacizumab and chemotherapyBevacizumab and chemotherapy
0100.0%100.0%
2064.9%54.4%
4042.2%29.6%
6027.4%16.1%
8017.8%8.8%
Primary publication: Oaknin A, Gladieff L, Martínez-García J, Villacampa G, Takekuma M, De Giorgi U, et al. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial. Lancet. 2024;403(10421):31-43. PubMedDOI

Appears in

Sources

  1. Oaknin A, Gladieff L, Martínez-García J, Villacampa G, Takekuma M, De Giorgi U, et al. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial. Lancet. 2024;403(10421):31-43.

    PubMedDOI