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A systematic review of phase II trials exploring anti-PD-1/PD-L1 combinations in patients with solid tumors

F Martorana1, I Colombo1, G Treglia2

  • 1Department of Oncology, Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland.

Cancer Treatment Reviews
|October 23, 2021
PubMed
Abstract

Insights

Phase II trials for PD-1/PD-L1 inhibitors combined with other cancer therapies show varied results. Most trials are single-arm, focusing on response rates, but few combinations gain regulatory approval.

Area of Science:

  • Oncology
  • Immunotherapy
  • Clinical Trials

Background:

  • Numerous combinations of PD-1/PD-L1 inhibitors with anti-cancer therapies are under clinical investigation.
  • The utility of phase II trials in assessing the efficacy and safety of these combinations remains unclear.

Purpose of the Study:

  • To systematically evaluate the landscape of phase II trials for PD-1/PD-L1 inhibitor combinations.
  • To analyze study designs, endpoints, and outcomes of these trials.

Main Methods:

  • Systematic search of PubMed and Cochrane Library for phase II trials (Jan 2018 - Dec 2020).
  • Inclusion of trials combining PD-1/PD-L1 inhibitors with systemic therapy and/or radiotherapy.
  • Registration of study design, primary endpoint, and main outcomes for each included paper.

Main Results:

  • 119 articles on 65 regimens were analyzed, with PD-1 inhibitors (pembrolizumab, nivolumab) being common backbone agents.
  • Combinations primarily involved other immunotherapies, targeted therapies, chemotherapy, or radiotherapy.
  • Most trials were single-arm (73%), with response rate as the frequent endpoint (58%). Objective responses varied widely (0-91%), and severe adverse events ranged from 0-100%.

Conclusions:

  • The phase II trial landscape for PD-1/PD-L1 inhibitor combinations is heterogeneous.
  • Combinations of two immunotherapeutic agents were most frequently studied.
  • Only a small percentage (8%) of indications derived from these trials received regulatory approval.
Keywords:
CombinationsImmunotherapyPhase II trialsanti-Programmed Death Ligand-1anti-Programmed Death-1

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