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. 2023 Aug;72(8):2649-2657.
doi: 10.1007/s00262-023-03449-9. Epub 2023 Apr 17.

Safety and efficacy of the anti-PD1 immunotherapy with nivolumab in trichoblastic carcinomas

Affiliations

Safety and efficacy of the anti-PD1 immunotherapy with nivolumab in trichoblastic carcinomas

E Toulemonde et al. Cancer Immunol Immunother. 2023 Aug.

Abstract

Trichoblastic carcinoma is a rare malignant cutaneous adnexal tumor with a risk of local invasion and distant metastasis. As of today, there is no consensus for the treatment of locally advanced or metastatic trichoblastic carcinoma. "AcSé Nivolumab" is a multi-center Phase II basket clinical trial (NCT03012581) evaluating the safety and efficacy of nivolumab in several cohorts of rare, advanced cancers. Here we report the results of nivolumab in patients with trichoblastic carcinoma. Of the eleven patients enrolled in the study, five patients had been previously treated by sonic hedgehog inhibitors. The primary endpoint 12-week objective response rate was 9.1% (N = 1/11) with 1 partial response. Six patients who progressed under previous lines of treatment showed stable disease at 12 weeks, reflecting a good control of the disease with nivolumab. Furthermore, 54.5% of the patients (N = 6/11) had their disease under control at 6 months. The 1-year overall survival was 80%, and the median progression-free survival was 8.4 months (95%CI, 5.7 to NA). With 2 responders (2 complete responses), the best response rate to nivolumab at any time was 18.2% (95%CI, 2.3-51.8%). No new safety signals were identified, and adverse events observed herein were previously described and well known with nivolumab monotherapy. These results are promising, suggesting that nivolumab might be an option for patients with advanced trichoblastic carcinomas. Further studies on larger cohorts are necessary to confirm these results and define the role of nivolumab in the treatment of trichoblastic carcinomas.

Keywords: Adnexal tumors; Anti-PD1; Immunotherapy; Nivolumab; Trichoblastic carcinoma.

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Conflict of interest statement

AM: Over the last 5 years, AM has provided time for consulting and participation to scientific advisory boards of the following companies commercializing PD-1/PD-L1 targeted immunotherapies: BMS, MSD, Pfizer, Sanofi, Merck Serono, Roche/Genentech, Astra Zeneca. Gustave Roussy has received funding for clinical trials from the following companies: BMS, MSD, Pfizer, Sanofi, Merck Serono, Roche/Genentech, Astra Zeneca. AM through Gustave Roussy has received translational research grants from BMS, Foundation MSD Avenir, Sanofi and Astra Zeneca. NM: over the last 5 years, NM has provided time for consulting and participation to scientific advisory boards of BMS, MSD, Novartis, Pierre Fabre, Sanofi, Sun pharma. NM received grants from BMS and MSD for clinical and translational research. CN: over the last 5 years, CN has provided time for consulting and participation to scientific advisory boards of BMS, MSD, Novartis, Pierre Fabre and Sanofi. MBB: over the last 5 years, MBB has provided time as speaker for Sun Pharma and has received grant from Roche for translational research. MDP: over the last years, MDP has provided time as speaker and investigator for BMS and MSD, and speaker for Novartis. ESB: over the last five years, ESB has provided time for consulting and participation to scientific advisory boards for BMS, MSD, Merck Serono and Lilly. ESV received grants from AstraZeneca. MB: over the last 5 years, MB has provided time for scientific advisory board for BMS, time for consulting for Innate Pharma, CerbaResearch, Quantum Genomics, has provided time as a speaker for Kyowa kirin, Takeda, and has received translational research grants from Takeda and Kyowa kirin. EMN: Novartis, Pierre Favre. FLD: over the past years, FLD has provided time for consulting and participation to scientific advisory boards of Daiichi, Lilly, Seagen, Novartis, Pfizer, Roche, Sandoz, Myriad, has provided time as a speaker for Amgen, Lilly, Novartis, Pierre Fabre. LM: over the past years, LM has provided time for consulting and participation to scientific advisory boards of the following companies: Sun Pharma, Novartis, Pierre Fabre and MSD, and has participated in congress with the same companies. The other authors have declared no conflicts of interest.

Figures

Fig. 1
Fig. 1
Abdominal CT in November 2018 (A, B) and in November 2020 (C, D) showing a complete regression of liver metastasis
Fig. 2
Fig. 2
Swimming plot for each patient indicating the best response to nivolumab and durability of response (months)
Fig. 3
Fig. 3
A Overall survival and B progression-free survival of trichoblastic carcinoma patients

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