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


Ontology type: schema:ScholarlyArticle      Open Access: True


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

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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30 ConclusionIn
31 MethodsThe study
32 NanoString analysis
33 PD-1 antibody
34 PD-L1 expression
35 RECIST v1.1
36 ResultsTwelve patients
37 activity
38 adult patients
39 advanced osteosarcoma
40 adverse events
41 agents
42 analysis
43 antibodies
44 antitumor activity
45 benefit rate
46 benefits
47 clinical benefit
48 clinical benefit rate
49 combination strategies
50 complete response
51 completion
52 cut
53 data cut
54 death
55 design
56 disease
57 drug-related grade 3
58 endpoint
59 enrollment
60 evaluable tumor samples
61 events
62 expression
63 expression signatures
64 future trials
65 gene expression signatures
66 grade 3
67 immunomodulatory agents
68 materials
69 median overall survival
70 median progression-free survival
71 mixed treatment response
72 molecular profile
73 months
74 osteosarcoma
75 overall survival
76 partial response
77 pathway
78 patient enrollment
79 patients
80 phase 2 study
81 phase 2 trial
82 positive samples
83 primary endpoint
84 profile
85 progression-free survival
86 rate
87 response
88 results
89 safety
90 samples
91 signatures
92 significant antitumor activity
93 stable disease
94 stage 1
95 strategies
96 study
97 study treatment
98 survival
99 time
100 treatment
101 treatment response
102 treatment-related deaths
103 trials
104 tumor gene expression signatures
105 tumor samples
106 two-stage design
107 v1.1
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