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IMagyn050

Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG 3015/ENGOT-OV39)

Phase 3N = 1,301NCT03038100

Population
Patients with newly diagnosed untreated FIGO stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Design
Multicentre, placebo-controlled, double-blind randomised phase III trial. 1301 patients with newly diagnosed untreated FIGO stage III or IV ovarian cancer, after primary cytoreductive surgery with macroscopic residual disease or planned for neoadjuvant chemotherapy with interval surgery, were stratified by FIGO stage, ECOG performance status, tumour immune cell PD-L1 staining and treatment strategy and randomly assigned 1:1 to atezolizumab 1,200 mg or placebo (day 1, cycles 1-22) with paclitaxel plus carboplatin (cycles 1-6) plus bevacizumab 15 mg/kg (cycles 2-22; perioperative bevacizumab omitted in neoadjuvant patients). Co-primary end points investigator-assessed PFS and OS in the ITT and PD-L1-positive populations. PD-L1-positive: PD-L1-expressing tumour immune cells of 1% or more of tumour area (VENTANA SP142), 784 of 1301 patients (60%) per the full text (PMC8189598). Arm sizes from the full text: 651 atezolizumab, 650 placebo.
Primary endpoint
PFS, OS
Arms
  • Placebo plus chemotherapy and bevacizumab (control, n = 650): Placebo plus paclitaxel, carboplatin and bevacizumab 15 mg/kg
  • Atezolizumab plus chemotherapy and bevacizumab (experimental, n = 651): Atezolizumab 1,200 mg plus paclitaxel, carboplatin and bevacizumab 15 mg/kg
People
Moore KN, GOG 3015/ENGOT-OV39
PFSHR 0.92 (95% CI 0.79–1.07)Δ median PFS+1.1 monthsPFSHR 0.80 (95% CI 0.65–0.99)Δ median PFS+2.3 months
Show the numbers
Results reported for IMagyn050
EndpointAnalysisAtezolizumab plus chemotherapy and bevacizumabPlacebo plus chemotherapy and bevacizumabEffect
PFSprimaryMoore 2021median 19.5 monthsmedian 18.4 monthsHR 0.92 (95% CI 0.79–1.07)P=0.28Investigator-assessed PFS.
PFSPD-L1-positive populationprimaryMoore 2021median 20.8 monthsmedian 18.5 monthsHR 0.80 (95% CI 0.65–0.99)P=0.038Investigator-assessed PFS in a co-primary population. The abstract states that the interim, immature overall survival results showed no significant benefit from atezolizumab (no figures given).
Results reported for IMagyn050
EndpointAnalysisAtezolizumab plus chemotherapy and bevacizumabPlacebo plus chemotherapy and bevacizumabEffect
PFSprimaryMoore 2021median 19.5 monthsmedian 18.4 monthsHR 0.92 (95% CI 0.79–1.07)P=0.28Investigator-assessed PFS.
PFSPD-L1-positive populationprimaryMoore 2021median 20.8 monthsmedian 18.5 monthsHR 0.80 (95% CI 0.65–0.99)P=0.038Investigator-assessed PFS in a co-primary population. The abstract states that the interim, immature overall survival results showed no significant benefit from atezolizumab (no figures given).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.920.79–1.07
PFS0.80.65–0.99
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Atezolizumab plus chemotherapy and bevacizumab (experimental)
  • Placebo plus chemotherapy and bevacizumab (control)

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

Data table (modelled values)
MonthsAtezolizumab plus chemotherapy and bevacizumabPlacebo plus chemotherapy and bevacizumab
0100.0%100.0%
1265.3%63.6%
2442.6%40.5%
3726.8%24.8%
4917.5%15.8%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%01020304050Months (modelled)
  • Atezolizumab plus chemotherapy and bevacizumab (experimental)
  • Placebo plus chemotherapy and bevacizumab (control)

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

Data table (modelled values)
MonthsAtezolizumab plus chemotherapy and bevacizumabPlacebo plus chemotherapy and bevacizumab
0100.0%100.0%
1364.8%61.4%
2642.0%37.8%
3927.3%23.2%
5217.7%14.3%
Primary publication: Moore KN, Bookman M, Sehouli J, Miller A, Anderson C, Scambia G, et al. Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG 3015/ENGOT-OV39). J Clin Oncol. 2021;39(17):1842-1855. PubMedDOI

Appears in

Sources

  1. Moore KN, Bookman M, Sehouli J, Miller A, Anderson C, Scambia G, et al. Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG 3015/ENGOT-OV39). J Clin Oncol. 2021;39(17):1842-1855.

    PubMedDOI