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Nivolumab and ipilimumab in recurrent or refractory cancer of unknown primary: a phase II trial
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Nivolumab and ipilimumab in recurrent or refractory cancer of unknown primary: a phase II trial
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Journal Article
Nivolumab and ipilimumab in recurrent or refractory cancer of unknown primary: a phase II trial
2023
Overview
Cancer of unknown primary has a dismal prognosis, especially following failure of platinum-based chemotherapy. 10-20% of patients have a high tumor mutational burden (TMB), which predicts response to immunotherapy in many cancer types. In this prospective, non-randomized, open-label, multicenter Phase II trial (EudraCT 2018-004562-33; NCT04131621), patients relapsed or refractory after platinum-based chemotherapy received nivolumab and ipilimumab following TMB
high
vs. TMB
low
stratification. Progression-free survival (PFS) represented the primary endpoint; overall survival (OS), response rates, duration of clinical benefit and safety were the secondary endpoints. The trial was prematurely terminated in March 2021 before reaching the preplanned sample size (
n
= 194). Among 31 evaluable patients, 16% had a high TMB ( > 12 mutations/Mb). Overall response rate was 16% (95% CI 6-34%), with 7.7% (95% CI 1-25%) vs. 60% (95% CI 15-95%) in TMB
low
and TMB
high
, respectively. Although the primary endpoint was not met, high TMB was associated with better median PFS (18.3 vs. 2.4 months) and OS (18.3 vs. 3.6 months). Severe immune-related adverse events were reported in 29% of cases. Assessing on-treatment dynamics of circulating tumor DNA using combined targeted hotspot mutation and shallow whole genome sequencing as part of a predefined exploratory analysis identified patients benefiting from immunotherapy irrespective of initial radiologic response.
Standard of care for unfavorable-risk cancer of unknown primary (CUP) comprises platinum-based chemotherapy as first-line treatment, however therapeutic options remain limited. Here the authors report the results of a phase II trial of combined nivolumab (anti-PD1) and ipilimumab (anti-CTLA4) in patients with unfavorable CUP.
Publisher
Nature Publishing Group UK,Nature Publishing Group,Nature Portfolio
Subject
/ 692/4017
/ Antineoplastic Combined Chemotherapy Protocols - adverse effects
/ Cancer
/ Genomes
/ Humanities and Social Sciences
/ Humans
/ Ipilimumab - therapeutic use
/ Mutation
/ Neoplasms, Unknown Primary - drug therapy
/ Neoplasms, Unknown Primary - genetics
/ Patients
/ Platinum
/ Science
/ Survival
/ Tumors
