Vaccination against PD-L1 with IO103 a Novel Immune Modulatory Vaccine in Basal Cell Carcinoma: A Phase IIa Study

Cancers

Lone Skov¹  Jeanette Kaae¹  Claus Zachariae¹  SigneLedou Nielsen²  AyakoWakatsuki Pedersen³  Eva Ehrnrooth³  NicolaiGrønne Jørgensen⁴  Özcan Met⁴  MadsHald Andersen⁴  JacobHandlos Grauslund⁴  IngeMarie Svane⁴ 

[1] Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, 2900 Hellerup, Denmark;Department of Pathology, Herlev and Gentofte Hospital, 2730 Herlev, Denmark;IO Biotech ApS, 2200 Copenhagen, Denmark;National Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Herlev and Gentofte Hospital, University of Copenhagen, 2730 Herlev, Denmark;

关键词: vaccine;    basal cell carcinoma;    PD-L1;    immunotherapy;    clinical trial;   

DOI  :  10.3390/cancers13040911

来源: DOAJ

【 摘 要 】

Antitumor activity of immune checkpoint blocking antibodies against programmed death 1 (PD-1) in basal cell carcinoma (BCC) has been described. IO103 is a peptide vaccine against the major PD-1 ligand PD-L1. A phase IIa study of vaccination with IO103 and Montanide adjuvant was conducted in patients with resectable BCC (NCT03714529). Vaccinations were given six times every 2 weeks (q2w), followed by three vaccines q4w in responders. Primary endpoints were clinical responses of target tumors, change in target tumor size and immune responses to the vaccine. Secondary endpoint was safety. One tumor per patient was designated target tumor and biopsied twice during the course of vaccination. Synchronous non-target BCCs were not biopsied during vaccinations. Ten patients were vaccinated (six patients received six vaccinations and four patients received nine vaccinations). A partial response (PR) was seen in two target tumors. Two complete responses (CR) and one PR were observed in eight non-target tumors in four patients. No tumors progressed. Related adverse events were grade 1 and reversible. Immune responses against IO103 were induced in blood samples from nine of ten and skin-infiltrating lymphocytes from five of the nine patients. The regressions seen in non-target tumors suggest that IO103 may be effective against a subtype of BCC.

【 授权许可】

Unknown