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Efficacy and safety of IO103 a novel anti PD-L1 vaccine in basal cell carcinoma.

2020; Lippincott Williams & Wilkins; Volume: 38; Issue: 15_suppl Linguagem: Inglês

10.1200/jco.2020.38.15_suppl.e22070

1527-7755

Nicolai Grønne Jørgensen, Jeanette Kaae, Jacob Handlos Grauslund, Özcan Met, Inge Marie Svane, E. Ehrnrooth, Mads Hald Andersen, Claus Zachariae, Lone Skov,

Tumors and Oncological Cases

e22070 Background: Basal cell carcinoma (BCC) is the most frequent malignancy. Case reports have described effect of immune checkpoint blocking antibodies (ICB) against PD-1 in BCC (Cannon et al. 2018, Chang et al. 2017, Ikeda et al. 2016, Winkler et al. 2017). Autoimmune side effects of ICB are well known and limits a wider use in BCC. IO103 is a peptide vaccine against major programmed death (PD) ligand 1 (PD-L1). In a first-in-man study of IO103 in patients with multiple myeloma (NCT03042793) regression of co-existing BCC was observed in two patients which prompted the current study. Methods: A single arm phase IIa study of subcutaneous IO103 (q2w six times followed optionally by q4w an additional 3 times) with the adjuvant Montanide for patients with BCC (NCT03714529). Eligible patients had at least one biopsy verified BCC suitable for sequential biopsies, and no severe autoimmune comorbidity. The primary endpoints were categorical clinical responses of target tumors, percent change in largest diameter of target tumor and immune responses to the vaccine. Secondary endpoint was safety. One tumor per patient was designated target tumor, if more than one tumor the remaining were designated non-target tumors. Only target tumors were sequentially biopsied during vaccinations. Results: Ten patients were included at the department of Dermatology, Herlev and Gentofte Hospital, Denmark between November 19 th , 2018 and October 21 st , 2019. Based on target lesion assessment, one patient achieved partial response. Two additional patients achieved CR in non-target lesions, including one lesion that had recurred after previous surgery. Categorical clinical responses are given in table. Adverse events were max CTCAE Grade 2 and related events were only CTCAE Grade 1 reversible reactions. Vaccine induced immune responses against PD-L1 were detected in blood samples from eight of ten patients and vaccine specific skin-infiltrating lymphocytes from five of eight tested patients. Conclusions: In this exploratory study, one target tumor achieved partial response. Nonetheless, the two clearances and one partial response of non-target tumors suggest that IO103 may be effective against BCCs. The vaccine was well tolerated. Understanding the underlying molecular mechanisms would be needed to select patients for further studies with IO103. Clinical trial information: NCT03714529. [Table: see text]