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Talimogene laherparepvec in combination with pembrolizumab leads to a complete response in a patient with refractory Merkel cell carcinoma.

ABSTRACT:

SUBMITTER: Lara KM

PROVIDER: S-EPMC6226586 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Talimogene laherparepvec in combination with pembrolizumab leads to a complete response in a patient with refractory Merkel cell carcinoma.

Lara Kristi M KM In Gino K GK Matcuk George R GR Mehta Arjun A Hu James S JS

JAAD case reports 20181107 10

PMID: 30450405

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Project description:ImportancePatients with advanced sarcoma have limited treatment options. Talimogene laherparepvec (T-VEC) has been shown to increase tumor-specific immune activation via augmenting antigen presentation and T-cell priming.ObjectiveTo examine whether T-VEC in combination with pembrolizumab is associated with increased tumor-infiltrating lymphocyte infiltration and programmed death-ligand 1 expression and thus with increased antitumor activity in patients with locally advanced or metastatic sarcoma.Design, setting, and participantsThis open-label, single-institution phase 2 interventional trial of T-VEC plus pembrolizumab enrolled 20 patients with locally advanced or metastatic sarcoma between March 16 and December 4, 2017, for whom at least 1 standard systemic therapy had failed. The median duration of therapy was 16 weeks (range, 7-67 weeks). Reported analyses include data through December 14, 2018.InterventionPatients received pembrolizumab (200-mg flat dose) intravenously and T-VEC (first dose, ≤4 mL × 106 plaque-forming units [PFU]/mL; second and subsequent doses, ≤4 mL × 108 PFU/mL) injected into palpable tumor site(s) on day 1 of each 21-day cycle.Main outcomes and measuresThe primary end point was objective response rate (ORR; complete response and partial response) at 24 weeks determined by Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1, criteria. Secondary end points included best ORR by immune-related RECIST criteria, progression-free survival rate at 24 weeks, overall survival, and safety.ResultsAll 20 patients (12 women [60%]; median age, 63.5 years [range, 24-90 years]) were evaluable for response. The study met its primary end point of evaluating the best ORR at 24 weeks determined by RECIST, version 1.1, criteria; the best ORR was 30% (95% CI, 12%-54%; n = 6). The ORR overall was 35% (95% CI, 15%-59%; n = 7). The incidence of grade 3 treatment-related adverse events was low (4 patients [20%]). There were no grade 4 treatment-related adverse events or treatment-related deaths.Conclusions and relevanceIn this phase 2 clinical trial, treatment with T-VEC plus pembrolizumab was associated with antitumor activity in advanced sarcoma across a range of sarcoma histologic subtypes, with a manageable safety profile. This combination therapy met its predefined primary study end point; further evaluation of T-VEC in combination with pembrolizumab for patients with select sarcoma subtypes is planned.Trial registrationClinicalTrials.gov identifier: NCT03069378.

Dataset Information

Talimogene laherparepvec in combination with pembrolizumab leads to a complete response in a patient with refractory Merkel cell carcinoma.

Publications

Talimogene laherparepvec in combination with pembrolizumab leads to a complete response in a patient with refractory Merkel cell carcinoma.

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