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Neo-adjuvant pembrolizumab in stage IV high-grade serous ovarian cancer: the phase II Neo-Pembro trial

S L Aronson1,2, B Thijssen3,4, M Lopez-Yurda5

  • 1Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.

Nature Communications
|April 14, 2025
PubMed

Insights

Adding pembrolizumab to chemotherapy in high-grade serous ovarian cancer (HGSOC) showed promising results. Major pathologic responses were observed in 27% of patients, with long-term survival benefits and potential biomarkers identified.

Area of Science:

  • Oncology
  • Immunology
  • Genetics

Background:

  • Immune checkpoint inhibitors (ICIs) show limited efficacy in high-grade serous ovarian cancer (HGSOC).
  • Understanding factors influencing ICI response in HGSOC is crucial for improving treatment outcomes.
  • Identifying predictive biomarkers can guide patient selection for immunotherapy.

Purpose of the Study:

  • To assess the impact of neoadjuvant pembrolizumab combined with chemotherapy on immune activation in untreated stage IV HGSOC.
  • To evaluate pathologic response rates and their association with clinical outcomes.
  • To identify potential biomarkers predicting response to pembrolizumab in HGSOC.

Main Methods:

  • Phase 2 clinical trial (Neo-Pembro study) involving 33 untreated stage IV HGSOC patients.
  • Combination therapy: carboplatin-paclitaxel chemotherapy with neoadjuvant pembrolizumab.
  • Assessment of intratumoral immune activation via multiplexed immunofluorescence and gene expression analysis.
  • Evaluation of pathologic response, overall survival (OS), progression-free survival (PFS), and circulating tumor DNA (ctDNA) clearance.

Main Results:

  • Significant immune activation observed, including increased CD8+ T-cells and enhanced TNF-α and interferon-γ signaling.
  • Major pathologic responses achieved in 27% of patients (9/33), strongly associated with immune activation and improved OS.
  • Major responders demonstrated high rates of long-term survival and recurrence-free survival.
  • ctDNA clearance was observed in all major responders, correlating with prolonged PFS and OS.
  • PD-L1 expression and homologous recombination deficiency (HRD) were identified as potential predictive biomarkers for major response.

Conclusions:

  • Neoadjuvant pembrolizumab in combination with chemotherapy is well-tolerated and induces significant immune activation in HGSOC.
  • Major pathologic response is associated with favorable long-term clinical outcomes and ctDNA clearance.
  • PD-L1 expression and HRD may serve as valuable biomarkers for identifying HGSOC patients likely to benefit from neoadjuvant pembrolizumab.

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