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Tedopi®

Tedopi®

Tedopi® is OSE’s most advanced product,  in Phase 3  (named Atalante 1) in patients with non-small cell lung cancer (NSCLC) after immune checkpoint inhibitor failure. The Step-1 of the ‘Atalante-1’ Phase 3 has showned positive results including benefit in overall survival and good safety profile in non-small cell lung cancer patients after failure with immune checkpoint inhibitor therapies compared to chemotherapy.

Tedopi® has shown positive Step-1 Phase 3 results of its Atalante 1 trial with primary endpoint met: 12-month survival rate in Tedopi® treated patients.

Tedopi® is also being investigated in:

  • Pancreatic cancer in a Phase 2 under the sponsorship of the GERCOR, a cooperative group in oncology,
  • Ovarian cancer in a Phase 2 under the sponsorship of ARCAGY-GINECO, another cooperative group in oncology,
  • NSCLC , in combination with checkpoint inhibitor Opdivo® (nivolumab), in a Phase 2 under the sponsorship of the Italian Foundation FoRT.

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 including benefit in overall survival and good safety profile. Based on these positive data, OSE Immunotherapeutics will engage with U.S. and European health authorities to evaluate the best regulatory strategy for this indication.

 

 

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.

Based on these positive data, OSE Immunotherapeutics will engage with U.S. and European health authorities to evaluate the best regulatory strategy for this indication.

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).

More information on ClinicalTrials.gov

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.

TEDOPaM study aims at comparing Tedopi® in combination with FOLFIRI chemotherapy versus FOLFIRI, in HLA-A2+ patients with stable disease after 4 months of standard chemotherapy with FOLFORINOX, a combination chemotherapy with folinic acid, fluorouracil, irinotecan and oxaliplatin. The primary endpoint of the trial is the one-year survival rate.

Ovarian cancer: The clinical trial is sponsored by the “Association de Recherche sur les CAncers dont GYnécologiques (ARCAGY-GINECO)” on behalf of GINECO, lead group for the TEDOVA trial of the European Network for Gynaecological Trial Groups (ENGOT). It will be supported in part by a research grant from the Investigator-Initiated Studies Program of MSD (Merck Sharp & Dohme Corp), a subsidiary of Merck & Co., Inc.”, which will provide Keytruda® (pembrolizumab).

The three arm TEDOVA study aims at evaluating neo-epitope-based vaccine Tedopi® as a maintenance treatment, alone or in combination with anti-PD-1 Keytruda®, versus the best supportive care in platinum-sensitive recurrent ovarian cancer patients with controlled disease after platinum-based chemotherapy.

Non-small cell lung cancer (NSCLC), in combination with Opdivo® : the Phase 2 clinical trial is sponsored and conducted by the Italian Oncology Foundation FoRT and supported by Bristol Myers Squibb, which provides Opdivo®, and OSE Immunotherapeutics which provides Tedopi® for the study as well as a partial financial support.

This three-arm Phase 2 study will evaluate neo-epitope-based vaccine Tedopi® in combination with Bristol Myers Squibb’s Opdivo® (nivolumab), an immune checkpoint inhibitor, or Tedopi® plus chemotherapy or chemotherapy alone as second-line treatment in HLA-A2 positive patients with metastatic NSCLC after first-line chemo-immunotherapy.