Abstract 1019P
Background
OSE2101 (Tedopi) is an anticancer vaccine increasing overall survival (OS) with HR of 0.59 (p=0.017) versus Standard of Care Chemotherapy (SoC CT) in the population of interest (PoI) of HLA-A2+ NSCLC patients with IO secondary resistance after sequential CT-IO (ESMO 2021 #47LBA). The objective of this analysis was to explore the pattern of activity of OSE2101.
Methods
118 NSCLC EGFR and ALK negative patients were randomized (2:1) in OSE2101 or SoC (docetaxel or pemetrexed) in the PoI. OS of OSE2101 versus SoC was described according to best response (partial response (PR), Stable Disease (SD) and Progressive Disease (PD)) and to the administration of post progression anticancer treatment. OS was described in Late Progressors (LP) defined as no RECIST 1.1 nor clinical PD within the first 6 months after randomization.
Results
Median (95%CI) OS in months by best response and by post progression anticancer treatment are described in the table. 16 (20%) patients fulfilled the criteria for Late Progressors with OSE2101. Late Progressors included 4 (25%) patients with PR and 12 (75%) patients with prolonged SD. mOS was 14.7 months with 1-year OS rate of 68%. mPFS was 8.8 months with 23% of patients progression-free at 1-year. Table: 1019P
| mOS (months) | OSE2101 n=80 | SoC n=38 | |
| By Best Response | |||
| PR | n=6 11.2 (5.4, NE) | n=7 13.8 (2.6, NE) | HR=0.75 (0.18, 3.23) |
| SD | n=36 13.1 (8.8, 16.8) | n=19 9.4 (6.5, 12.2) | HR=0.61 (0.33, 1.14) |
| PD | n=32 8.0 (5.4, 11.1) | n=7 5.0 (1.0, 7.2) | HR=0.45 (0.19, 1.04) |
| By Post Progression anticancer treatment | |||
| With anticancer treatment | n=55 13.5 (9.6,16.6) | n=16 10.6 (7.2, 16.1) | HR=0.71 (0.38, 1.30) |
| Without anticancer treatment | n=25 6.3 (3.6, 7.6) | n=22 4.5 (2.3, 8.3) | HR=0.76 (0.41, 1.41) |
Conclusions
In advanced HLA-A2+ NSCLC patients with IO secondary resistance after sequential CT-IO, OS was longer with OSE2101 versus SoC regardless the use of post progression anticancer treatment. By Best Response to study treatement, OS was longer with OSE2101 in patients with Stable Disease or Progressive Disease compared to SoC. Late progressors with OSE2101 were mainly driven by long Stable Disease. These data suggest that the cancer vaccine OSE2101 may act as an anti-tumor brake in controlling the tumor growth regardless of best response.
Clinical trial identification
EudraCT: 2015-003183-36; NCT02654587.
Editorial acknowledgement
We thank Pierre Attali (Medical Expert, MD) and François Montestruc (Statistics, eXYSTAT) for their support in the writing of the abstract.
Legal entity responsible for the study
Ose Immunotherapeutics.
Funding
Ose Immunotherapeutics.
Disclosure
M.R. Garcia Campelo: Financial Interests, Personal, Advisory Role: Roche/Genentech, MSD Oncology, AstraZeneca, Bristol-Myers Squibb; Financial Interests, Personal, Advisory Board: Pfizer, Novartis, Takeda, Boehringer Ingelheim, Janssen Oncology; Financial Interests, Personal, Speaker’s Bureau: Roche, AstraZeneca, Bristol-Myers Squibb, Pfizer, Novartis, Takeda, Boehringer Ingelheim, MSD Oncology, Sanofi/Aventis, Janssen Oncology, Amgen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche/Genentech, MSD Oncology, Pfizer. E. Felip: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith Kline, Janssen, Medical Trends, Merck Sharp & Dohme, Pfizer, Puma, Sanofi, Takeda, Merck Serono, Peptomyc, Regeneron, Syneos Health, F. Hoffmann-La Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristol Myers Squibb, Eli Lilly, Medscape, Merck Sharp & Dome, Peervoice, Pfizer, Springer, Touch Medical, Amgen, F. Hoffmann-La Roche, Janssen, Medical Trends, Merck Serono; Financial Interests, Personal, Invited Speaker, Independent member: Grifols; Financial Interests, Institutional, Invited Speaker, Clinical Trial: F. Hoffmann-La Roche Ltd, Merck Sharp & Dohme Corp, AstraZeneca AB, Daiichi Sankyo Inc, Exelixis Inc, Merck KGAA, Janssen Cilag International NV, GlaxoSmithKline Research & Development Limited, AbbVie Deutschland GmbH & Co KG, Novartis Farmaceutica SA, Bayer Consumer Care AG, Takeda Pharmaceuticals International, Boehringer Ingelheim International GmbH, Pfizer S.L.U., Amgen Inc, Bristol-Myers Squibb International Corporation (BMS), Mirati Therapeutics Inc; Non-Financial Interests, Leadership Role, President Elect (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Member, Member of ESMO Nominating Committee and Compliance Committee: ESMO; Non-Financial Interests, Leadership Role, Member of Board of Directors and the Executive Committee (2017-Sept 2021): IASLC (International Association for the Study of Lung Cancer); Non-Financial Interests, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform). B. Besse: Financial Interests, Institutional, Funding: 4D Pharma, AbbVie, Amgen, Aptitude Health, AstraZeneca, BeiGene, Blueprint Medicines, BMS, Boehringer Ingelheim, Celgene, Cergentis, Cristal Therapeutics, Daiichi Sankyo, Eli Lilly, GSK, Janssen, Onxeo, Ose Immunotherapeutics, Pfizer, Roche-Genentech, Sanofi, Takeda, Tolero Pharmaceuticals. F. Cappuzzo: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, PharmaMar, Mirati, Novocure, OSE, and MSD; Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, Mirati, PharmaMar, Novocure, Ose, Galecto and MSD. F. Denis: Financial Interests, Personal, Invited Speaker, lecture: Chugai; Financial Interests, Personal, Invited Speaker, Lecture: AstraZeneca, Merck, Takeda; Financial Interests, Institutional, Advisory Board, Institution receiver was Hyperion. Collaboration stopped in March 2020: Slvan; Financial Interests, Institutional, Invited Speaker, Institution (Hyperion) has participations in Kelindi (non-oncological software editor): Kelindi; Financial Interests, Institutional, Stocks/Shares, Hyperion has stocks in Kelindi (non-oncological software editor): Kelindi; Non-Financial Interests, Member: ASCO. W. Hilgers: Financial Interests, Personal, Advisory Board: AstraZeneca, Janssen; Financial Interests, Personal, Other, Honoraria: MSD Oncology. D. Debieuvre: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Janssen, Pfizer, Ose Immunotherapeutics, Novartis, Sanofi-Aventis, Amgen, Roche; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Institutional, Funding: Roche, AstraZeneca, Janssen, MSD, Pfizer, BMS, Lilly, Boehringer Ingelheim, GSK, Chugaï, Chiesi, Novartis, Takeda, Bayer, Sanofi-Aventis. D. Galetta: Financial Interests, Personal, Advisory Board: Roche, Boheringer Ingelheim, Eli Lilly Italia, AstraZeneca Italia, Takeda; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb; Financial Interests, Institutional, Other, Small cell lung cancer translational study: AstraZeneca Italia. S. Viteri Ramirez: Financial Interests, Personal, Advisory Board: Merck Healthcar KGAA Germany, Bristol Myers Squibb S.A. U, Puma Biotechnology; Financial Interests, Personal, Invited Speaker: Takeda Farmaceutica España SA, MSD de España SA, AstraZeneca Farmaceutica Spain, Roche Farma SA; Financial Interests, Personal, Expert Testimony: Reddy Pharma Iberia SAU. W. Schuette: Financial Interests, Personal, Other, Honoraria: Roche, MSD, Novartis; Financial Interests, Personal, Advisory Board: Roche, MSD, Novartis. A. Zer: Financial Interests, Personal, Invited Speaker: Roche, BMS, MSD, Takeda, Pfizer, Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca, Steba, Oncohost; Financial Interests, Personal, Stocks/Shares: Nixio; Financial Interests, Institutional, Research Grant: BMS. B. Vasseur: Financial Interests, Personal, Full or part-time Employment: Ose Immunotherapeutics; Financial Interests, Personal, Other, Actions: Ose Immunotherapeutics. R. Dziadziuszko: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, SeattleGenetics, Pfizer, Takeda, Regeneron, MSD, Bristol Myers-Squibb, PharmaMar, Bayer; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim, FoundationMedicine; Financial Interests, Personal, Expert Testimony: Novartis; Financial Interests, Personal and Institutional, Invited Speaker: Roche, AstraZeneca, MSD, Amgen, Celon Pharma, Pfizer, Novartis, Brsitol Myers-Squibb, Eli Lilly, Loxo; Financial Interests, Invited Speaker: BeiGene, Ardigen, Ose Immunotherapeutics; Financial Interests, Personal and Institutional, Other, Subinvestigator and ad hoc Consultant: PDC* line Pharma; Non-Financial Interests, Institutional, Product Samples: Novartis, Pfizer, AstraZeneca, Roche; Other, Travel: Roche, Bristol Myers-Squibb, AstraZeneca. G. Giaccone: Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Institutional, Research Grant: Karyopharm. All other authors have declared no conflicts of interest.