TY - JOUR

T1 - Vaccination against pd-l1 with io103 a novel immune modulatory vaccine in basal cell carcinoma

T2 - A phase iia study

AU - Jørgensen, Nicolai Grønne

AU - Kaae, Jeanette

AU - Grauslund, Jacob Handlos

AU - Met, Özcan

AU - Nielsen, Signe Ledou

AU - Pedersen, Ayako Wakatsuki

AU - Svane, Inge Marie

AU - Ehrnrooth, Eva

AU - Andersen, Mads Hald

AU - Zachariae, Claus

AU - Skov, Lone

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - Basal cell carcinoma

KW - Clinical trial

KW - Immunotherapy

KW - PD-L1

KW - Vaccine

U2 - 10.3390/cancers13040911

DO - 10.3390/cancers13040911

M3 - Journal article

C2 - 33671555

AN - SCOPUS:85101184337

VL - 13

SP - 1

EP - 15

JO - Cancers

JF - Cancers

SN - 2072-6694

IS - 4

M1 - 911

ER -