Clinical trialPhase 3Cervical cancer

Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial

Lancet · 2024410 patients

Oaknin A, Gladieff L, Martínez-García J, Villacampa G, Takekuma M, De Giorgi U, et al. Lancet. 2024. 403:31-43

Study type: Clinical trial
Study name: BEATcc (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030)
Phase: Phase 3
Design: Investigator-initiated, open-label randomised trial (92 centres in Europe, Japan and the USA)
Sample size: 410 patients
Source: Lancet · 2024
Trial registration: NCT03556839

In plain words

In this study, adding the immunotherapy drug atezolizumab to chemotherapy and bevacizumab in advanced or recurrent cervical cancer raised the median survival from about 23 months to about 32 months. Serious side effects were only slightly more common.

Key results

13.7 vs 10.4 months

Median progression-free survival

HR 0.62 (95% CI 0.49–0.78); p<0.0001

32.1 vs 22.8 months

Median overall survival (interim analysis)

HR 0.68 (95% CI 0.52–0.88); p=0.0046

79% vs 75%

Grade 3 or higher adverse events

Drugs in this study:Bevacizumab (Avastin)Carboplatin (Paraplatin)Cisplatin (Platinol)Paclitaxel (Taxol)Atezolizumab (Tecentriq)

Dose and schedule cards

Atezolizumab + bevacizumab + paclitaxel and platinum (BEATcc)

First-line metastatic (IVB), persistent or recurrent disease that is untreated and not amenable to curative treatment; no PD-L1 testing requiredCycle length: Every 21 daysOn the page “Cervical cancer” · Metastatic, persistent or recurrent disease: first line

First-line metastatic (IVB), persistent or recurrent disease that is untreated and not amenable to curative treatment; no PD-L1 testing required

Drug	Dose	Route	Schedule
Atezolizumab	1200 mg	IV	Day 1
Paclitaxel	175 mg/m²	IV	Day 1
Cisplatin or carboplatin	Cisplatin 50 mg/m² or carboplatin AUC 5	IV	Day 1
Bevacizumab	15 mg/kg	IV	Day 1

Cycle length: Every 21 days
Duration: Until progression, unacceptable toxicity or withdrawal; in patients with a complete response after at least 6 cycles, continuation with bevacizumab and atezolizumab alone was permitted at the physician’s discretion

Atezolizumab does not have a cervical cancer indication on its FDA label; the dose and schedule are taken from the trial protocol. Grade 3 or higher adverse events occurred in 79% vs 75%, and grade 1–2 diarrhoea, arthralgia, pyrexia and rash were more frequent with atezolizumab.

On the page “Cervical cancer” · Metastatic, persistent or recurrent disease: first line

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Treatment arms and regimens

1Atezolizumab + standard therapy

Atezolizumab 1200 mg IV on day 1 of each 3-week cycle, with standard therapy: paclitaxel 175 mg/m² IV + cisplatin 50 mg/m² or carboplatin AUC 5 IV + bevacizumab 15 mg/kg IV, all on day 1 of each 3-week cycle.

Treatment continued until disease progression, unacceptable toxicity, patient withdrawal or death. In patients who reached a complete response after at least 6 cycles, continuation with the biological agents alone (bevacizumab + atezolizumab) was allowed at the investigator's discretion.

2Standard therapy (as in GOG 240)

Paclitaxel 175 mg/m² IV + cisplatin 50 mg/m² or carboplatin AUC 5 IV + bevacizumab 15 mg/kg IV, all on day 1 of each 3-week cycle; until disease progression, unacceptable toxicity, patient withdrawal or death. After a complete response following at least 6 cycles, continuation with bevacizumab alone was allowed at the investigator's discretion.

Source of the regimen details: Abstract of the paper (Lancet 2024) and ClinicalTrials.gov NCT03556839 (doses, day 1 every 3 weeks, and continuation of biological agents after complete response)

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Patients with metastatic (stage IVB), persistent or recurrent cervical cancer that was measurable, previously untreated and not amenable to curative surgery or radiotherapy; regardless of PD-L1 status.

Endpoints

Dual primary endpoints: investigator-assessed progression-free survival (RECIST 1.1) and overall survival in the intention-to-treat population.

Safety and side effects

Grade 3 or higher adverse events occurred in 79% of the experimental group and 75% of the standard group. Grade 1–2 diarrhoea, arthralgia, fever and rash were increased with atezolizumab.

Clinical significance and place in guidelines

The NCCN guideline (version 2.2026) has added atezolizumab with platinum–paclitaxel–bevacizumab as a category 1 preferred first-line regimen for recurrent/metastatic disease. Unlike KEYNOTE-826, enrolment in BEATcc did not depend on PD-L1 status. The regulatory approval status of this combination varies between countries and should be checked before prescribing.

Limitations

Open-label design (no placebo); all patients received bevacizumab, so the results cannot be generalised to patients with contraindications to bevacizumab; overall survival is reported from an interim analysis.

Original article (DOI)PubMed ClinicalTrials.gov

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.