Pembrolizumab in advanced osteosarcoma: results of a single-arm, open-label, phase 2 trial View Full Text


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Article Info

DATE

2021-02-12

AUTHORS

Kjetil Boye, Alessandra Longhi, Tormod Guren, Susanne Lorenz, Stine Næss, Michela Pierini, Ingeborg Taksdal, Ingvild Lobmaier, Marilena Cesari, Anna Paioli, Ayca M. Løndalen, Elisabetta Setola, Ivar Hompland, Leonardo A. Meza-Zepeda, Kirsten Sundby Hall, Emanuela Palmerini

ABSTRACT

AimTo evaluate the activity and safety of the PD-1 antibody pembrolizumab in adult patients with advanced osteosarcoma. Material and methodsThe study was a single-arm, open-label, phase 2 trial in patients with unresectable, relapsed osteosarcoma. The primary endpoint was clinical benefit rate (CBR) at 18 weeks of treatment, defined as complete response, partial response, or stable disease using RECIST v1.1. The trial had a Simon´s two-stage design, and ≥ 3 of 12 patients with clinical benefit in stage 1 were required to proceed to stage 2. The trial is registered with ClinicalTrials.gov, number NCT03013127. NanoString analysis was performed to explore tumor gene expression signatures and pathways.ResultsTwelve patients were enrolled and received study treatment. No patients had clinical benefit at 18 weeks of treatment, and patient enrollment was stopped after completion of stage 1. Estimated median progression-free survival was 1.7 months (95% CI 1.2–2.2). At time of data cut-off, 11 patients were deceased due to osteosarcoma. Median overall survival was 6.6 months (95% CI 3.8–9.3). No treatment-related deaths or drug-related grade 3 or 4 adverse events were observed. PD-L1 expression was positive in one of 11 evaluable tumor samples, and the positive sample was from a patient with a mixed treatment response. ConclusionIn this phase 2 study in advanced osteosarcoma, pembrolizumab was well-tolerated but did not show clinically significant antitumor activity. Future trials with immunomodulatory agents in osteosarcoma should explore combination strategies in patients selected based on molecular profiles associated with response. More... »

PAGES

2617-2624

References to SciGraph publications

  • 2020-02-21. Immuno-genomic landscape of osteosarcoma in NATURE COMMUNICATIONS
  • <error retrieving object. in <ERROR RETRIEVING OBJECT
  • 2016-04-20. Gemcitabine and docetaxel in relapsed and unresectable high-grade osteosarcoma and spindle cell sarcoma of bone in BMC CANCER
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s00262-021-02876-w

    DOI

    http://dx.doi.org/10.1007/s00262-021-02876-w

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1135345606

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/33580363


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    23 schema:description AimTo evaluate the activity and safety of the PD-1 antibody pembrolizumab in adult patients with advanced osteosarcoma. Material and methodsThe study was a single-arm, open-label, phase 2 trial in patients with unresectable, relapsed osteosarcoma. The primary endpoint was clinical benefit rate (CBR) at 18 weeks of treatment, defined as complete response, partial response, or stable disease using RECIST v1.1. The trial had a Simon´s two-stage design, and ≥ 3 of 12 patients with clinical benefit in stage 1 were required to proceed to stage 2. The trial is registered with ClinicalTrials.gov, number NCT03013127. NanoString analysis was performed to explore tumor gene expression signatures and pathways.ResultsTwelve patients were enrolled and received study treatment. No patients had clinical benefit at 18 weeks of treatment, and patient enrollment was stopped after completion of stage 1. Estimated median progression-free survival was 1.7 months (95% CI 1.2–2.2). At time of data cut-off, 11 patients were deceased due to osteosarcoma. Median overall survival was 6.6 months (95% CI 3.8–9.3). No treatment-related deaths or drug-related grade 3 or 4 adverse events were observed. PD-L1 expression was positive in one of 11 evaluable tumor samples, and the positive sample was from a patient with a mixed treatment response. ConclusionIn this phase 2 study in advanced osteosarcoma, pembrolizumab was well-tolerated but did not show clinically significant antitumor activity. Future trials with immunomodulatory agents in osteosarcoma should explore combination strategies in patients selected based on molecular profiles associated with response.
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