LIÈGE, BELGIUM & GRENOBLE, FRANCE -- PDC*line Pharma, a clinical-stage biotech company developing a new class of immunotherapies for cancers, presented the primary results of its phase I/II clinical trial for PDC*lung01, an innovative off-the-shelf therapeutic cancer vaccine, at the ESMO-IO 2024 conference today. PDC*lung01, when combined with pembrolizumab, demonstrated significant clinical benefits for stage IV Non-Small Cell Lung Cancer (NSCLC) patients with PD-L1 ≥ 50%, along with a mild safety profile.

“PDC*lung01 in combination with anti-PD-1 showed a very promising and durable response as well as a significant immune response with indications of a relationship with clinical outcome in cohort B2. The data suggest that this combination could offer a clinically meaningful tumor response in stage IV NSCLC patients, along with a compelling safety profile,” said Prof Johan Vansteenkiste, emeritus professor in respiratory oncology at KU Leuven in Belgium and chair of the Data and Safety Monitoring Board.

The phase I/II trial (PDC-LUNG-101, NCT03970746) evaluated the safety, tolerability, immunogenicity, and preliminary clinical activity of PDC*lung01 in NSCLC patients. The trial included 67 HLA-A02:01-positive NSCLC patients across five European countries. Patients received six weekly doses of PDC*lung01 through subcutaneous and intravenous administration. It assessed the vaccine in two doses both as a single agent (cohorts A1, A2 for stage II & IIIa NSCLC) and in combination with pembrolizumab (cohorts B1, B2 for stage IV NSCLC). Key clinical activity parameters, such as ORR and PFS, were analyzed in the B1 and B2 cohorts, with primary results reported from the high-dose, B2 cohort. With a database cut-off date on July 18, 2024, the patients’ median follow-up was 19.5 months (95% CI 13.8-25.6).