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

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...

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Published in:Cancer Immunology, Immunotherapy Immunotherapy, 2023-08, Vol.72 (8), p.2649-2657
Main Authors: Toulemonde, E., Chevret, S., Battistella, M., Neidhardt, E. M., Nardin, C., Le Du, F., Meyer, N., Véron, M., Gambotti, L., Lamrani-Ghaouti, A., Jamme, P., Chaffaut, C., De Pontville, M., Saada-Bouzid, E., Beylot-Barry, M., Simon, C., Jouary, T., Marabelle, A., Mortier, L.
Format: Article
Language:English
Subjects:
Antineoplastic Combined Chemotherapy Protocols
Cancer
Cancer Research
Carcinoma
Hedgehog Proteins
Humans
Immunology
Immunotherapy
Medicine
Medicine & Public Health
Metastases
Nivolumab
Oncology
Patients
PD-1 protein
Response rates
Safety
Skin Neoplasms - drug therapy
Skin Neoplasms - pathology
Survival
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Summary: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.
ISSN:0340-7004
1432-0851
DOI:10.1007/s00262-023-03449-9