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PROMISE-meso

A multicentre randomised phase III trial comparing pembrolizumab versus single-agent chemotherapy for advanced pre-treated malignant pleural mesothelioma: the European Thoracic Oncology Platform (ETOP 9-15) PROMISE-meso trial

Phase 3N = 144NCT02991482

Population
Adults with malignant pleural mesothelioma, performance status 0-1, progressing after or on previous platinum-based chemotherapy, unselected for PD-L1 status.
Design
Open-label, randomised (1:1) phase 3 trial (ETOP 9-15): pembrolizumab 200 mg every 3 weeks versus institutional choice of single-agent chemotherapy (gemcitabine or vinorelbine) in relapsed pleural mesothelioma, unselected for PD-L1 status. Patients randomised to chemotherapy could cross over to pembrolizumab at progression. Primary endpoint PFS assessed by blinded independent central review (BICR); secondary endpoints OS, investigator-assessed PFS, ORR and safety. Randomisation September 2017 to August 2018. The paper's abstract does not name the analysis population.
Primary endpoint
PFS
Arms
  • Pembrolizumab (experimental, n = 73): Pembrolizumab 200 mg every 3 weeks
  • Single-agent chemotherapy (control, n = 71): Institutional choice of gemcitabine or vinorelbine
People
Popat S
PFSHR 1.06 (95% CI 0.73–1.53)Δ median PFS−0.9 monthsOSHR 1.12 (95% CI 0.74–1.69)Δ ORR+16 points
Show the numbers
Results reported for PROMISE-meso
EndpointAnalysisPembrolizumabSingle-agent chemotherapyEffect
PFSRandomised patients (analysis population not stated in the abstract)Progression-free survival assessed by blinded independent central reviewprimarymedian follow-up 11.8 monthsPopat 2020median 2.5 months (2.1–4.2)median 3.4 months (2.2–4.3)HR 1.06 (95% CI 0.73–1.53)P=0.76Median follow-up 11.8 months (IQR 9.9-14.5); 118 BICR-PFS events at the 20 February 2019 data cutoff.
OSRandomised patients (analysis population not stated in the abstract)primarymedian follow-up 17.5 monthsPopat 2020——HR 1.12 (95% CI 0.74–1.69)P=0.59Secondary endpoint. Median follow-up 17.5 months (IQR 14.8-19.7) to 21 August 2019. The abstract states that no OS difference was detected, including after adjustment for crossover; it prints no median OS for either arm, and the full text could not be opened, so none is recorded. 45 patients (63%) assigned to chemotherapy received pembrolizumab at progression.
ORRRandomised patients (analysis population not stated in the abstract)primaryPopat 202022% (13–33%)6% (2–14%)P=0.004Secondary endpoint. Exploratory efficacy analyses by PD-L1 status showed no improvements in ORR, PFS or OS, according to the abstract.
Results reported for PROMISE-meso
EndpointAnalysisPembrolizumabSingle-agent chemotherapyEffect
PFSRandomised patients (analysis population not stated in the abstract)Progression-free survival assessed by blinded independent central reviewprimarymedian follow-up 11.8 monthsPopat 2020median 2.5 months (2.1–4.2)median 3.4 months (2.2–4.3)HR 1.06 (95% CI 0.73–1.53)P=0.76Median follow-up 11.8 months (IQR 9.9-14.5); 118 BICR-PFS events at the 20 February 2019 data cutoff.
OSRandomised patients (analysis population not stated in the abstract)primarymedian follow-up 17.5 monthsPopat 2020——HR 1.12 (95% CI 0.74–1.69)P=0.59Secondary endpoint. Median follow-up 17.5 months (IQR 14.8-19.7) to 21 August 2019. The abstract states that no OS difference was detected, including after adjustment for crossover; it prints no median OS for either arm, and the full text could not be opened, so none is recorded. 45 patients (63%) assigned to chemotherapy received pembrolizumab at progression.
ORRRandomised patients (analysis population not stated in the abstract)primaryPopat 202022% (13–33%)6% (2–14%)P=0.004Secondary endpoint. Exploratory efficacy analyses by PD-L1 status showed no improvements in ORR, PFS or OS, according to the abstract.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS1.060.73–1.53
OS1.120.74–1.69
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%02468Months (modelled)
  • Pembrolizumab (experimental)
  • Single-agent chemotherapy (control)

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

Data table (modelled values)
MonthsPembrolizumabSingle-agent chemotherapy
0100.0%100.0%
257.4%66.5%
433.0%44.2%
618.9%29.4%
98.2%16.0%
Primary publication: Popat S, Curioni-Fontecedro A, Dafni U, Shah R, O'Brien M, Pope A, et al. A multicentre randomised phase III trial comparing pembrolizumab versus single-agent chemotherapy for advanced pre-treated malignant pleural mesothelioma: the European Thoracic Oncology Platform (ETOP 9-15) PROMISE-meso trial. Ann Oncol. 2020;31(12):1734-1745. PubMedDOI

Appears in

Sources

  1. Popat S, Curioni-Fontecedro A, Dafni U, Shah R, O'Brien M, Pope A, et al. A multicentre randomised phase III trial comparing pembrolizumab versus single-agent chemotherapy for advanced pre-treated malignant pleural mesothelioma: the European Thoracic Oncology Platform (ETOP 9-15) PROMISE-meso trial. Ann Oncol. 2020;31(12):1734-1745.

    PubMedDOI