Tedopi® is OSE’s most advanced product, in Phase 3 in patients with non-small cell lung cancer (NSCLC) after immune checkpoint inhibitor failure. Primary endpoint was met in the predefined Step-1 analysis of this Phase 3 with a 12-month survival rate in Tedopi® treated patients.
Tedopi® is also in Phase 2 in pancreatic cancer, a trial sponsored by the GERCOR cooperative group in oncology.
Tedopi® is a proprietary combination of nine optimized neo-epitopes plus one epitope giving universal helper T cell response targeting T cell activation.
Tedopi® is a specific treatment for HLA-A2+ patients, a key receptor for the cytotoxic T-immune response.
Tedopi® benefits from strong patent protection and has received orphan status in the U.S. for HLA-A2 positive patients in NSCLC. In Europe, the product benefits from a personalized medicine status in HLA-A2 positive patients.
Phase 1 and 2 trials demonstrated the ability of Tedopi® to restore the immune-surveillance of cancer cells in HLA-A2 positive responder patients while inducing early T-cell memory response.
Additionally, a Phase 2 trial conducted in patients suffering from Non-Small Cell Lung Cancer (NSCLC) with a poor prognosis, showed both a better survival rate in the Tedopi® treated group, as well as a positive correlation between epitope response and survival.
Step-1 of the Phase 3 clinical trial (Atalante 1) evaluating Tedopi® in HLA-A2 positive patients with NSCLC, after failure from immune checkpoint inhibitors (PD-1/PD-L1), has shown positive results with primary endpoint met: 12-month survival rate in Tedopi® treated patients.
ABOUT THE TEDOPI® CLINICAL PROGRAM
Tedopi® is under evaluation in two major cancer indications: in NSCLC with an ongoing Phase 3 trial and in pancreatic cancer with an ongoing Phase 2.
NSCLC: The Phase 3 trial, Atalante 1, evaluates the benefit of Tedopi® in HLA-A2+ patients at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following failure of a checkpoint inhibitor, compared to current standard chemotherapy treatments. The primary endpoint is overall survival.
OSE Immunotherapeutics presented positive step-1 Phase 3 results for Tedopi® in NSCLC at the European Society for Medical Oncology Virtual Congress 2020.
- The primary endpoint, 1-year overall survival (OS) rate in the mITT* population, was achieved: a 46% 1-year overall survival (OS) rate for Tedopi® treated patients [95% CI: 33%, 59%] and more than the planned upper limit in the protocol (pre-specified futility boundary H0 <25% to reject; pre-specified alternative efficacy H1> 40% considered as clinically meaningful). This 46% OS rate was 10% higher than the standard of care (SoC) chemotherapy at 36% [95% CI: 21%, 54%].
- 1-year OS rate was confirmed at 47.5% in the modified per protocol** population (those without major deviations) considered as the targeted population in this indication [95% CI: 34.3%, 60.9%] versus SoC at 34.4% [95% CI: 18.6% 53.2%].
- Median overall survival was longer in the ITT population at 9.8 months in the Tedopi® group versus 8.7 months in the SoC group, HR: 0.71 [95% CI: 0.44, 1.16]; p=0.17.
- Median overall survival difference was statistically significant in the targeted per protocol population with Tedopi® at 11.1 months versus 8.7 months for SoC, p=0.037; HR: 0.57 [95% CI: 0.34, 0.97].
- Other main secondary endpoints included similar disease control rate at 6 and 12 months between the two treatment groups.
- The time to ECOG*** deterioration was significantly longer in the Tedopi® group (8.4 vs 4.4 months; p=0.002). Survival after progression was also significantly longer in the Tedopi® group (7.5 vs 4.4 months; p=0.022).
- Good tolerance profile of Tedopi® with significantly less severe Treatment Emergent Adverse Effects (TEAS) (Tedopi® 14% vs SoC 43%, p<0.001).
Overall, benefit/risk ratio is favorable for Tedopi® and better than that of SoC in this post checkpoint inhibitors treated population.
Following these positive data, OSE Immunotherapeutics will determine the best options for the product moving forward.
Due to the current COVID-19 outbreak and its potential impact on Step-2 of Atalante 1, following the recommendation from both IDMC and Steering Committee of the trial, OSE Immunotherapeutics voluntarily decided to terminate patient screening and accrual in the initially planned and now cancelled Step-2.
*mITT (multiple Intention-To-Treat) population: all randomized evaluable (≥12 months survival data) patients who received at least one dose of study treatment.
**Per protocol population: ITT population without protocol major deviations defined after a blind review by NSCLC experts.
*** The ECOG score is a performance scale used to quantify the general health condition of a patient. It is subdivided into 5 grades from (0) to (5), ranging from fully active (0) to fully disabled, then to death (5).
Pancreatic cancer: OSE Immunotherapeutics is collaborating with the oncology cooperative group GERCOR, a network of 300 cancer centers in France dedicated to clinical trials in solid cancers which is sponsoring a phase 2 clinical trial as part of PRODIGE intergroup.
The Phase 2 trial, named TEDOPaM, is supported by Bristol-Myers Squibb, which provides Opdivo® (nivolumab) for use in the study. OSE Immunotherapeutics provides Tedopi® and a partial financial support.
TEDOPaM study aims at evaluating Tedopi® as a maintenance therapy, alone or in combination with Opdivo® compared to Folfiri* alone, in HLA-A2 positive patients with stable disease after 4 months of standard chemotherapy with Folforinox, a combination chemotherapy with folinic acid, fluorouracil, irinotecan and oxaliplatin.