Pembrolizumab as first line therapy in patients with unresectable squamous cell carcinoma of the skin: Interim results of the phase 2 CARSKIN trial.

Maubec, E.; Boubaya, Marouane; Petrow, Peter; Basset-Séguin, Nicole; Grob, Jean‐Jacques; Dréno, Brigitte; Scheer-Senyarich, Isabelle; Helfen, Sabine; Quatrebarbes, Julie De; Poirier, E.; Deschamps, Lydia; Alloux, Céline; Lopez, Isabelle; Cherbal, Soufian; Leccia, Marie Thérèse; Beylot‐Barry, M.; Grange, Florent; Schischmanoff, Olivier; Tibi, Annick; Lévy, Vincent

doi:10.1200/jco.2018.36.15_suppl.9534

Cited by 22 publications

(20 citation statements)

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“…16 While surgical excision is curative in localized SCC of the skin, no effective treatment was available for locally advanced or metastatic disease, 17 until cemiplimab, a PD-1 inhibitor, was recently FDA-approved for this indication. 18 Though ORR of 47% was reported in patients with metastatic SCC of the skin treated with cemiplimab, 68% of patients either had received no prior systemic therapy or only one line of prior systemic therapy 19 In another study, an ORR of 40% has been reported in 10 patients with metastatic SCC of skin, majority of whom have not received prior systemic therapy. 20 Thus, findings from our study (ORR of 31% and CBR of 38%) is noteworthy given that all of our patients had refractory disease and 88% of them had received ≥1 prior systemic therapy.…”

Section: Discussionmentioning

confidence: 99%

Phase 2 study of pembrolizumab in patients with advanced rare cancers

Naing

Meric‐Bernstam

Stephen

et al. 2020

J Immunother Cancer

105

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BackgroundPatients with advanced rare cancers have poor prognosis and few treatment options. As immunotherapy is effective across multiple cancer types, we aimed to assess pembrolizumab (programmed cell death 1 (PD-1) inhibitor) in patients with advanced rare cancers.MethodsIn this open-label, phase 2 trial, patients with advanced rare cancers whose tumors had progressed on standard therapies, if available, within the previous 6 months were enrolled in nine tumor-specific cohorts and a 10th cohort for other rare histologies. Pembrolizumab 200 mg was administered intravenously every 21 days. The primary endpoint was non-progression rate (NPR) at 27 weeks; secondary endpoints were safety and tolerability, objective response rate (ORR), and clinical benefit rate (CBR).ResultsA total of 127 patients treated between August 15, 2016 and July 27, 2018 were included in this analysis. At the time of data cut-off, the NPR at 27 weeks was 28% (95% CI, 19% to 37%). A confirmed objective response (OR) was seen in 15 of 110 (14%) evaluable patients (complete response in one and partial response in 14). CBR, defined as the percentage of patients with an OR or stable disease ≥4 months, was 38% (n=42). Treatment was ongoing in 11 of 15 patients with OR at last follow-up. In the cohort with squamous cell carcinoma (SCC) of the skin, the NPR at 27 weeks was 36%, ORR 31%, and CBR 38%. In patients with adrenocortical carcinoma (ACC), NPR at 27 weeks was 31%, ORR 15%, and CBR 54%. In the patients with carcinoma of unknown primary (CUP), NPR at 27 weeks was 33%, ORR 23%, and CBR 54%. In the paraganglioma–pheochromocytoma cohort, NPR at 27 weeks was 43%, ORR 0%, and CBR 75%. Treatment-related adverse events (TRAEs) occurred in 66 of 127 (52%) patients, and 12 (9%) had grade ≥3 TRAEs. The most common TRAEs were fatigue (n=25) and rash (n=17). There were six deaths, all of which were unrelated to the study drug.ConclusionsThe favorable toxicity profile and antitumor activity seen in patients with SCC of skin, ACC, CUP, and paraganglioma–pheochromocytoma supports further evaluation of pembrolizumab in this patient population.Trial registration numberNCT02721732

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Section: Discussionmentioning

confidence: 99%

Phase 2 study of pembrolizumab in patients with advanced rare cancers

Naing

Meric‐Bernstam

Stephen

et al. 2020

J Immunother Cancer

105

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“…There are also reports of PD-1 inhibitors, particularly pembrolizumab, inducing keratoacanthomas 9 . However, despite these reports, the CARSKIN trial found that pembrolizumab can be used to successfully treat advanced cSCC, 10 and the US Food and Drug Administration recently approved a new PD-1 inhibitor cemiplimab for the treatment of metastatic cSCC. In the presented case, this patient did not have any adverse reactions to pembrolizumab when used as a monotherapy.…”

Section: Discussionmentioning

confidence: 99%

Eruptive squamous cell carcinomas in metastatic melanoma: An unintended consequence of immunotherapy

et al. 2019

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“…In CSCC, pembrolizumab is being tested in a phase II study of 150 adults with recurrent/metastatic or locally advanced unresectable CSCC (MK-3475-629/KEYNOTE-629, NCT03284424). The interim results of the preview clinical trial (CARSKIN, NCT02883556) presented at the American Society of Clinical Oncology (ASCO) meeting 2018 showed high RRs (42%) and a durable response, with a median of around seven months in patients with unresectable CSCC [126]. Pembrolizumab is also being examined in participants with locally advanced CSCC versus placebo after surgery and radiation (MK-3475-630/KEYNOTE-630, NCT03833167).…”

Section: Immunotherapy In Csccmentioning

confidence: 99%

Cutaneous Squamous Cell Carcinoma: From Biology to Therapy

Corchado-Cobos

García-Sancha

González-Sarmiento

et al. 2020

IJMS

123

111

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Cutaneous squamous cell carcinoma (CSCC) is the second most frequent cancer in humans and its incidence continues to rise. Although CSCC usually display a benign clinical behavior, it can be both locally invasive and metastatic. The signaling pathways involved in CSCC development have given rise to targetable molecules in recent decades. In addition, the high mutational burden and increased risk of CSCC in patients under immunosuppression were part of the rationale for developing the immunotherapy for CSCC that has changed the therapeutic landscape. This review focuses on the molecular basis of CSCC and the current biology-based approaches of targeted therapies and immune checkpoint inhibitors. Another purpose of this review is to explore the landscape of drugs that may induce or contribute to the development of CSCC. Beginning with the pathogenetic basis of these drug-induced CSCCs, we move on to consider potential therapeutic opportunities for overcoming this adverse effect.

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Pembrolizumab as first line therapy in patients with unresectable squamous cell carcinoma of the skin: Interim results of the phase 2 CARSKIN trial.

Cited by 22 publications

References 0 publications

Phase 2 study of pembrolizumab in patients with advanced rare cancers

Phase 2 study of pembrolizumab in patients with advanced rare cancers

Eruptive squamous cell carcinomas in metastatic melanoma: An unintended consequence of immunotherapy

Cutaneous Squamous Cell Carcinoma: From Biology to Therapy

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