As reported in The Lancet by Ana Oaknin, MD, and colleagues, the phase III BEATcc trial has shown that the addition of atezolizumab to bevacizumab and chemotherapy improved progression-free and overall survival in women with metastatic, persistent, or recurrent cervical cancer.

Ana Oaknin, MD

Study Details

The investigator-initiated BEATcc trial enrolled previously untreated patients with measurable metastatic (stage IVb), persistent, or recurrent disease that was not amenable to curative surgery or radiation. In the open-label trial, 410 patients from 93 sites in Europe (81%–85% of patients), Japan (13%–15%), and the United States (2%–5%) were randomly assigned between October 2018 and August 2021 to receive cisplatin at 50 mg/m² or carboplatin at area under the curve = 5, paclitaxel at 175 mg/m², and bevacizumab at 15 mg/kg on day 1 of  3-week cycles with (n = 206) or without (n = 204) atezolizumab at 1,200 mg on day 1 every 3 weeks. The dual primary endpoints were investigator-assessed progression-free survival and overall survival in the intention-to-treat population. Outcomes according to PD-L1 expression progression status are to be reported in a subsequent publication.

Progression-Free and Overall Survival

At the primary analysis data cutoff for progression-free survival in July 2023, median duration of follow-up was 32.9 months (95% confidence interval [CI] = 31.2–34.6 months). Median progression-free survival was 13.7 months (95% CI = 12.3–16.6 months) in the atezolizumab group vs 10.4 months (95% CI = 9.7–11.7 months) in the control group (hazard ratio [HR] = 0.62, 95% CI = 0.49–0.78, P < .0001). Rates at 12, 24, and 36 months were 58% vs 42%, 36% vs 19%, and 26% vs 12%, respectively.

Among patients with disease progression on study therapy, at least one subsequent therapy was received by 54% of 138 patients in the atezolizumab group and by 58% of 166 in the control group. Among these patients, an immune checkpoint inhibitor was received by 55 patients (33%) in the control group vs 4 patients (3%) in the atezolizumab group.

At interim overall survival analysis, median overall survival was 32.1 months (95% CI = 25.3–36.8 months) in the atezolizumab group vs 22.8 months (95% CI = 20.3–28.0 months) in the control group (HR = 0.68, 95% CI = 0.52–0.88, P = .0046). Rates at 12, 24, and 36 months were 84% vs 80%, 61% vs 49%, and 42% vs 26%, respectively. 

Adverse Events

Grade ≥ 3 or worse adverse events occurred in 79% of patients in the atezolizumab group and in 75% of patients in the standard group, most commonly hematologic adverse events, hypertension (18% vs 16%), and asthenia (11% vs 9%). Grade 1 or 2 diarrhea (36% vs 23%), arthralgia (32% vs 20%), pyrexia (22% vs 11%) and rash (19% vs 9%) were more common in the atezolizumab group. Adverse events led to discontinuation of any study treatment in 15% of those in the atezolizumab group vs 16% of the control group. The most common adverse events of special interest for those treated with atezolizumab were grade 1 or 2 hypothyroidism (8%), grade 1 or 2 hyperthyroidism (3%), and infusion-related reaction (3%). Fatal adverse events occurred in seven patients in the atezolizumab group vs six patients in the control group; three deaths in the atezolizumab group—due to obstructive jaundice, ileal perforation, and vaginal hemorrhage—were considered related to treatment.

The investigators concluded, “Adding atezolizumab to a standard bevacizumab plus platinum regimen for metastatic, persistent, or recurrent cervical cancer significantly improves progression-free and overall survival and should be considered as a new first-line therapy option.”

Dr. Oaknin, of the Vall d’Hebron Institute of Oncology, Vall d’Hebron Barcelona Hospital Campus, Barcelona, is the corresponding author for The Lancet article.

Disclosure: The study was funded by F. Hoffmann-La Roche. For full disclosures of the study authors, visit thelancet.com.