Abstract 1176P
Background
PDC*lung01 (IMP) is a therapeutic cancer vaccine consisting of an irradiated plasmacytoid dendritic cell line loaded with HLA-A*02:01 restricted peptides (NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1, Survivin and Melan-A) and able to prime and expand peptide-specific CD8+ T cells in vitro and in vivo, and is synergistic with anti-PD-1.
Methods
HLA-A*02 positive NSCLC patients are enrolled in 4 cohorts: resected stage II/IIIA in adjuvant setting treated with low dose (A1) or high dose (A2) of IMP as single agent following standard of care; or stage IV NSCLC with measurable disease, PD-L1 tumour proportion score ≥50% and no targetable driver mutation, treated with low dose (B1) or high dose (B2) of IMP in combination to pembrolizumab. The IMP is administered by subcutaneous and intravenous route weekly for 6 consecutive doses. Safety, tolerability and immune response are assessed and in addition clinical activity for B cohorts. We report here on the first 3 cohorts that have been completed.
Results
Of the 25 patients (6 in A1, 12 in A2 and 7 in B1) that started treatment, 22 received at least 5 doses and were evaluable. Treatment-related AEs were all Grade 1-2 and 1 Grade 3 with no dose-limiting toxicity (DLT) observed. Six patients experienced a serious adverse event (SAE), but none was considered related to the IMP. An antigen-specific CD8+ T-cell response was induced against the lung antigens of the IMP in 33%, 45% and 67% of evaluable patients in respectively A1, A2 and B1 cohort. The best objective response in 6 evaluable patients of the B1 cohort, according to RECIST criteria included 4 partial responses, 1 stable disease and 1 progressive disease with an objective response rate (ORR) of 66.7% (80% CI 33.3% - 90.7%).
Conclusions
PDC*lung01 treatment was feasible with an acceptable safety profile and was found to be biologically active to trigger an antitumor immune response in a significant number of patients. Interestingly, a very promising ORR was observed in combination with pembrolizumab in first line setting in stage IV patients. Updated results will be presented.
Clinical trial identification
NCT03970746.
Editorial acknowledgement
Legal entity responsible for the study
PDC*line Pharma SAS.
Funding
PDC*line Pharma SAS.
Disclosure
J.F. Vansteenkiste: Financial Interests, Institutional, Advisory Board: AstraZeneca, BMS, Daichi Sankyo, MSD, Pfizer, Roche, Janssen, Merck, Novartis, PDCline, Sanofi; Financial Interests, Institutional, Invited Speaker: AstraZeneca, BMS, Novartis, Janssen, Elil-Lilly, Roche; Financial Interests, Institutional, Research Grant: MSD. I. Demedts: Financial Interests, Personal, Other, invited speaker and participation in advisory board meetings: AstraZeneca, BMS, Boehringer, GSK, Lilly, MSD, Novartis, Pfizer, Roche, Takeda. E. Pons-Tostivint: Financial Interests, Institutional, Invited Speaker: AstraZeneca, BMS, Daiichi Sankyo, Sanofi, PDC Line, Takeda. B. Colinet: Financial Interests, Personal, Advisory Board: MSD, Sanofi, J&J, Boehringer Ingelheim, Amgen, AZ, Roche; Financial Interests, Personal, Invited Speaker: Sanofi; Non-Financial Interests, Invited Speaker, Association Francophone Belge d'Oncologie Thoracique: AFBOT. K. Cuppens: Financial Interests, Personal, Advisory Board: Hoffmann-La Roche, AstraZeneca, Merck Sharp Dohme, Bristol-Myers-Squibb, Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Pfizer, Bristol-Myers-Squibb; Financial Interests, Personal, Expert Testimony: Merck Sharp Dohme, AstraZeneca. L. Greillier: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, BMS, MSD, Novartis, Sanofi, Takeda, Roche; Financial Interests, Personal, Invited Speaker: Lilly, Pfizer, Roche; Financial Interests, Institutional, Invited Speaker: AstraZeneca, AbbVie, BMS, MSD, Novartis, Sanofi, Takeda, Pfizer, PharmaMar. D. Moro-Sibilot: Financial Interests, Personal, Advisory Board: Lilly, Roche, BMS, MSD, AbbVie, AbbVie, Becton Dickinson, Pfizer, Takeda, AstraZeneca, Boehringer Ingelheim, Novartis, GSK; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Institutional, Funding, IFCT clinical trials: Pfizer; Financial Interests, Institutional, Funding: Roche, AbbVie, AstraZeneca. M. Pérol: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, MSD, BMS, Lilly, Novartis, Takeda, Gritstone, Sanofi, Pfizer, Amgen, Janssen, GlaxoSmithKline; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, MSD, BMS, Boehringer Ingelheim, Takeda, Illumina, Pfizer, Roche; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche, Takeda, Boehringer Ingelheim. M. Sebastian: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Novartis, Takeda, Lilly, BMS, MSD, Merck, Johnson, Amgen; Financial Interests, Personal, Invited Speaker: Roche, GSK; Financial Interests, Institutional, Research Grant: AstraZeneca. M. Skrzypski: Financial Interests, Personal, Invited Speaker, Sponsored lecture: Boehringer Ingelheim; Non-Financial Interests, Principal Investigator, National PI (Poland) for PDC-LUNG-101 trial.: PDC*line Pharma. M. Collodoro: Financial Interests, Personal, Full or part-time Employment, QC manager at PDC*line Pharma: PDC*line Pharma. J. Plumas: Financial Interests, Personal, Full or part-time Employment, I am CSO of PDC*line Pharma: PDC*line Pharma; Financial Interests, Personal, Stocks/Shares: PDC*line Pharma. C. Debruyne: Financial Interests, Institutional, Sponsor/Funding: PDC*line Pharma; Financial Interests, Institutional, Stocks/Shares: PDC*line Pharma. A. Sibille: Financial Interests, Institutional, Advisory Board: Merck Sharp Dome, AstraZeneca, Bristol Myers Squibb, Roche, Pfizer. All other authors have declared no conflicts of interest.