Tedopi (OSE 2101) / OSE Immunotherapeutics, Chong Kun Dang - LARVOL DELTA

A randomized, non-comparative, phase II study of maintenance OSE2101 vaccine alone or in combination with nivolumab (nivo) or FOLFIRI after induction with FOLFIRINOX in patients (Pts) with advanced pancreatic ductal adenocarcinoma (aPDAC): First interim results of the TEDOPAM GERCOR D17-01 PRODIGE 63 STUDY. (ASCO 2022) - P2 | "Maintenance OSE2101 monotherapy showed a favorable safety profile and encouraging time to strategy failure warranting further evaluation. OSE2101 + nivo was associated with poorer outcomes leading to close Arm C. Following IDMC recommendation, the study is ongoing with the new design (maintenance FOLFIRI vs. FOLFIRI + OSE2101)."

Clinical • Combination therapy • P2 data • Inflammation • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Phase 3 trial of the therapeutic cancer vaccine OSE2101 versus docetaxel in patients with metastatic non-small cell lung cancer and secondary resistance to immunotherapy. (ASCO 2025) - P3 | "The ARTEMIA phase 3 study aims to confirm the benefit on survival and quality of life of the therapeutic cancer vaccine OSE2101 compared to docetaxel in second-line treatment of HLA-A2 positive patients with NSCLC and secondary resistance to immune checkpoint inhibitor. Recruitment is ongoing in North America and Europe."

Clinical • IO biomarker • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • HER-2 • ROS1

Maintenance with OSE2101 plus FOLFIRI vs FOLFIRI alone after FOLFIRINOX (FFX) induction in patients (Pts) with advanced pancreatic ductal adenocarcinoma (aPDAC): Primary endpoint results of a randomized TEDOPAM GERCOR D17-01 PRODIGE 63 trial. (ASCO 2025) - P2 | "TEDOPAM met its primary objective with minimal toxicity and positive outcomes of adding OSE2101 cancer vaccine to maintenance FOLFIRI, albeit mitigated by unexpectedly favorable OS in the control arm. Two complete responses were observed when adding OSE2101. Further follow-up is ongoing and translational analysis planned."

Clinical • Metastases • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Randomized Open-Label Controlled Study of Cancer Vaccine OSE2101 Versus Chemotherapy in HLA-A2-positive Patients with Advanced Non-Small Cell Lung Cancer with Resistance to Immunotherapy: ATALANTE-1. (PubMed, Ann Oncol) - "In HLA-A2 positive patients with advanced NSCLC and secondary resistance to immunotherapy, OSE2101 increased survival with better safety compared to chemotherapy. Further evaluation in this population is warranted."

Journal • Metastases • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Novel Coronavirus Disease • Oncology • Solid Tumor

The neo-epitope-based vaccine OSE2101 with or without pembrolizumab versus best supportive care as maintenance in platinum-sensitive recurrent ovarian cancer patients with controlled disease after platinum-based chemotherapy: The academic randomized TEDOVA/GINECO-OV244b/ENGOT-ov58 trial. (ASCO 2026) - "Funded by OSE Immunotherapeutics, SA, ARCAGY-GINECO organization, Merck (MSD) France Clinical Trial Registration Number: 2024-516096-32-00 Background: OSE2101 is a neo-epitope vaccine targeting 5 tumor-associated antigens (TP53, MAGE2, MAGE3, CEA and HER2) modified to increase both HLA-A2 and TCR affinity, designed to turn immunogenic 'cold' ovarian cancer (OC) to 'hot' tumors. This is the 1st trial demonstrating a significant improvement in PFS with a combination of a neo-epitope vaccine and an anti-PD1 as maintenance after platinum for patients with platinum sensitive relapsed OC progressing post-PARPi and bevacizumab."

Clinical • IO biomarker • Platinum sensitive • Musculoskeletal Pain • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2 • HER-2 • TP53

Results of a multicenter, phase II, open-label, randomized trial evaluating OSE2101 plus docetaxel or OSE2101 plus nivolumab as second-line therapy in metastatic non-small-cell lung cancer (NSCLC) progressing after first-line chemo-immunotherapy (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ARTEMIA phase 3 study: A randomized, open-label trial comparing the efficacy and safety of OSE2101 versus docetaxel in HLA-A2 positive patients with metastatic non-small cell lung cancer and secondary resistance to immune checkpoint inhibitors. (PubMed, Lung Cancer) - No abstract available

Checkpoint inhibition • Journal • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

OSE Immunotherapeutics Reports Positive Topline Results of TEDOVA Phase 2 Trial with Tedopi in Recurrent Ovarian Cancer (The Manila Times) - "The primary endpoint was met and results showed a statistically significant improvement in PFS for the combination of Tedopi and pembrolizumab compared to best supportive care (median PFS: 4.1 months vs 2.8 months; HR=0.53; p The combination with pembrolizumab to Tedopi was associated with an increased incidence of adverse events, including immune-related events, consistent with the mechanism of action of immunotherapy. These results will be presented on May 30, 2026, at the ASCO 2026 Annual Meeting in Chicago by Lead Investigator Alexandra Leary, MD, PhD."

P2 data • Platinum sensitive • Ovarian Cancer

Summary of second-line treatment of stage IV NSCLC without oncogenic addiction (PubMed, Bull Cancer) - "The introduction of immune checkpoint inhibitors (anti-PD-1/PD-L1) has revolutionized first-line treatment, but second-line options remain largely dependent on older chemotherapies such as docetaxel or pemetrexed...Innovative strategies are under investigation: antibody-drug conjugates (anti-TROP-2, anti-CEACAM-5), cancer vaccines (TEDOPI), external electric fields (TTFields), oncolytic viruses, and PROTACs. While some of these show promise in progression-free survival, global survival benefit remains modest. The identification of robust predictive biomarkers is essential for tailoring future therapies."

Biomarker • Clinical • Clinical guideline • Clinical protocol • IO biomarker • Journal • Observational data • Preclinical • Retrospective data • Review • CNS Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Psychiatry • Solid Tumor • CD8 • PTEN

OSE Immunotherapeutics Reports Full Year 2025 Unaudited Consolidated Financial Results and 2026 Q1 Cash Position (GlobeNewswire) - "Operating income in 2025 amounted to €2.7 million, primarily reflecting revenues generated by Tedopi’s supply of early access program in France for €1.4 million, and the deferred recognition of a portion of the $48 million upfront payment from the AbbVie licensing agreement on OSE-230 signed in April 2024 for €0.8 million....Research and development expenses increased by 11.5% over the period, amounting to €33.9 million in 2025, compared to €30.4 million the prior year. This increase reflects our development programs moving forward, notably the ongoing Phase 3 pivotal trial of Tedopi® – Artemia – actively recruiting, as well as a lower amount of Research Tax Credit (CIR) amounting to €4.6 million in 2025, compared to €5.3 million in 2024."

Commercial • Immunology • Inflammation • Solid Tumor

A Phase 1 dose-escalation study to evaluate safety, pharmacokinetics, and pharmacodynamics of OSE-279, an anti-PD-1 monoclonal antibody in patients with advanced solid tumours. (PubMed, Eur J Cancer) - P1/2 | "OSE-279 monotherapy was well tolerated with durable responses in patients with advanced solid tumours. The trial is continuing with OSE-279 combined with OSE2101, a therapeutic cancer vaccine in 1st line HLA-A2 positive PD-L1 ≥ 50% NSCLC. CLINICAL TRIAL REGISTRATION (NCT NUMBER: NCT05751798)."

Journal • P1 data • PK/PD data • Anal Carcinoma • Dermatology • Endocrine Disorders • Fatigue • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Pruritus • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Xerostomia • PD-L1

OSE Immunotherapeutics Announces Presentation of TEDOVA Phase 2 Topline Results of Tedopi in Ovarian Cancer at the ASCO 2026 Meeting (GlobeNewswire) - "TEDOVA is a three-arm Phase 2 study evaluating Tedopi ss a maintenance treatment, alone or in combination with anti-PD1 immune checkpoint inhibitor Keytruda (pembrolizumab), versus best supportive care in 185 patients in platinum-sensitive recurrent ovarian cancer with controlled disease after platinum-based chemotherapy who have already received both bevacizumab and a PARP (Poly ADP-Ribose Polymerase) inhibitor."

P2 data • Platinum sensitive • Ovarian Cancer

OSE Immunotherapeutics Accelerates Strategic Refocusing to Advance Late Stage Value Drivers Lusvertikimab and Tedopi (GlobeNewswire) - "The Company will pause development of OSE‑230, allowing OSE to focus its resources on late‑stage, high‑potential assets lusvertikimab (OSE‑127) and Tedopi. These two assets are expected to generate multiple clinical catalysts over the next three years."

Discontinued • Pipeline update • Immunology • Non Small Cell Lung Cancer • Ovarian Cancer

Expected Value Inflection Points over OSE’s three-year strategic plan (2026-2028) (GlobeNewswire) - "Q2 2026: Tedopi Ovarian Cancer Investigator Sponsored Trial Phase 2 read-out Q3 2026: Tedopi NSCLC Pivotal Phase 3 interim futility analysis H2 2026: Tedopi 2L NSCLC combo Investigator Sponsored Trial Phase 2 read-out....Q1 2028: Tedopi NSCLC Pivotal Phase 3 read-out."

P2 data • P3 data • Platinum sensitive • Non Small Cell Lung Cancer • Ovarian Cancer

TEDOPAM: OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC (clinicaltrials.gov) - P2 | N=156 | Recruiting | Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • UGT1A1

TEDOPAM: OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

New P2 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • UGT1A1

TEDOPAM: OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC (clinicaltrials.gov) - P2 | N=106 | Recruiting | Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group | N=156 ➔ 106

Enrollment change • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • UGT1A1

TEDOPAM: OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC (clinicaltrials.gov) - P2 | N=106 | Active, not recruiting | Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • UGT1A1

TEDOPAM: OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC (clinicaltrials.gov) - P2 | N=106 | Recruiting | Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • UGT1A1

OSE Immunotherapeutics Receives Second Positive IDMC Recommendation for Phase 3 ARTEMIA Trial Evaluating Tedopi in Non-Small Cell Lung Cancer (GlobeNewswire) - "The IDMC advised that the study should continue as planned, with no protocol changes. In line with the predefined study oversight plan, the IDMC, composed of independent clinical and statistical experts, conducted a comprehensive assessment of patient safety, trial conduct and key efficacy indicators. Based on this review, the IDMC recommended that the study continue without modifications, confirming the robustness of the trial’s conduct to date....The next IDMC review is scheduled for October 2026. Study enrollment is expected to conclude by year-end 2026. Tedopi NSCLC Pivotal Phase 3 interim futility analysis is expected in Q3 2026, with overall survival primary endpoint results anticipated in Q1 2028."

DSMB • Enrollment status • P3 data • Non Small Cell Lung Cancer

Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED) (clinicaltrials.gov) - P2 | N=105 | Active, not recruiting | Sponsor: Fondazione Ricerca Traslazionale | Recruiting ➔ Active, not recruiting | Trial completion date: May 2025 ➔ Sep 2028 | Trial primary completion date: Oct 2023 ➔ Sep 2027

Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study. (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Fondazione Ricerca Traslazionale

Circulating tumor DNA • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

OSE Immunotherapeutics Announces Positive Recommendation from Independent Data Monitoring Committee (IDMC) to Continue Pivotal Phase 3 ARTEMIA Trial Evaluating Tedopi in Non-Small Cell Lung Cancer (GlobeNewswire) - "A second IDMC review is anticipated in Q1 2026. Completion of recruitment in the ARTEMIA trial is foreseen for end of 2026, with readout for primary endpoint of overall survival in Q1 2028."

DSMB • Enrollment status • P3 data • Non Small Cell Lung Cancer

OSE2101 plus docetaxel or nivolumab as second-line therapy in metastatic non-small cell lung cancer (mNSCLC) progressing after first-line chemoimmunotherapy (Combi-TED) (ESMO 2025) - P2 | "Legal entity responsible for the study Fondazione Ricerca Traslazionale (FoRT). Funding Sponsored by Fondazione Ricerca Traslazionale (FoRT), with the support of OSE Immunotherapeutics SA."

Clinical • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Net treatment benefit in ARTEMIA trial comparing OSE2101 to docetaxel in patient with non-small cell lung cancer (NSCLC): Outcomes prioritization based on investigators preferences (ESMO 2025) - P3 | "Legal entity responsible for the study OSE Immunotherapeutics SA. Funding OSE Immunotherapeutics SA."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor