Intermediary results of high dose PDC*lung01 combined with pembrolizumab show mild safety profile, immunological activity and promising tumor response in Non-Small Cell Lung Cancer patients
Combination of high dose PDC*lung01 with pembrolizumab in 19 evaluable patients resulted in objective response rate of 63.2% and median progression-free survival of 10.9 months
Liège, Belgium, and Grenoble, France, April 8, 2024 – PDC*line Pharma, a clinical-stage biotech company developing a new class of potent and scalable active immunotherapies for cancers, announces the interim results from the last cohort of patients in its phase I/II clinical trial (PDC-LUNG-101, NCT03970746) with PDC*lung01.
PDC*lung01 is the company’s off-the shelf therapeutic cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC). The preliminary data on the last cohort of patients was presented through both an oral presentation and a poster at the American Association for Cancer Research (AACR) Annual Meeting 2024. This data revealed that the high dose PDC*lung01 combined with pembrolizumab shows an immunological activity in a majority of patients and a promising antitumor response in stage IV NSCLC with a mild safety profile.
The phase I/II trial (PDC-LUNG-101) aimed to assess the safety, tolerability, immunogenicity and preliminary clinical activity of PDC*lung01 in NSCLC patients, alone or in combination with anti-PD-1 treatment. PDC*lung01 was administered weekly through both subcutaneous and intravenous routes, in six consecutive doses. The trial was conducted across 17 clinical sites in France, Belgium, Germany, the Netherlands and Poland. PDC*lung01 was administered to a total of 67 evaluable HLA-A*02:01 positive NSCLC patients, at two dose levels and settings:
- As a single agent in the adjuvant setting (cohorts A1: Low Dose, A2: High Dose)
- Combined with standard of care anti-PD-1 monotherapy in first-line stage IV (metastatic) NSCLC patients with a PD-L1 tumor proportion score of ≥50% and no targetable driver mutation (cohorts B1: Low Dose, B2: High Dose)
Clinical activity parameters such as Objective Response Rate (ORR) and Progression-Free Survival (PFS) were assessed only in cohorts B1 and B2. The B2 cohort included 45 patients. PDC*Line is reporting preliminary efficacy results for 19 evaluable patients in the B2 cohort that reached the 9-month PFS mark... PDC*line Pharma's Press Release -
