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.
Predefined Step-1 positive results of the Phase 3 clinical trial Atalante 1 (April 1, 2020)
Considering the population of the treated patients in both trial arms randomized at least 12 months before the time of the Step-1 analysis (N=99), the primary objective of Step-1 of the Atalante 1 trial planned in the protocol was met:
In the Phase 3 Step-1 analysis, the statistically positive preliminary results show at least 12-month survival for 29 patients out of 63 patients in the Tedopi® arm, corresponding to a 12-month survival rate of 46% with the lower limit (33%) of the 95% confidence interval* [33% – 59%], above the pre-specified futility boundary of 25%.
The observed rate of 46% is also above the assumption of a survival rate of 40% specified for the alternative efficacy hypothesis in the protocol.
In the chemotherapy control arm the results show at least 12-month survival for 13 patients out of 36 patients, corresponding to a 12-month survival rate of 36%.
Complete analysis of Step-1 results and further discussions with regulatory agencies will determine the best options for additional clinical development of Tedopi® and potential partnership plans.
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.
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.