Tedopi® is a novel T-cell epitope-based cancer vaccine targeting five tumor-associated antigens, an activating and differentiated off-the-shelf immunotherapy expanding tumor specific T-lymphocytes in HLA-A2 cancer patients.

Tedopi® has been evaluated in a clinical Phase 3 study in patients with non-small cell lung cancer (NSCLC) after immune checkpoint inhibitor failure (ICI) – Trial named Atalante-1.

Compelling Phase 3 Clinical Data

Tedopi® is the first cancer vaccine to show clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) post-ICI failure in advanced or metastatic NSCLC.

An article, titled “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” published in the peer-reviewed publication in Annals of Oncology features positive data from the randomized international Phase 3 study showing that novel cancer vaccine Tedopi® improves overall survival with a better safety and quality of life profile in monotherapy compared to chemotherapy in HLA-A2 positive patients with advanced or metastatic NSCLC who have progressed at least 12 weeks after sequential treatment with chemotherapy and ICI.

Main results of the first Phase 3 clinical trial of Tedopi® in HLA-A2+ patients with NSCLC

This Phase 3 clinical trial has demonstrated a significant therapeutic benefit in patients with secondary resistance (1) to immune checkpoint inhibitors (ICI) defined as patients with failure to platinum-based chemotherapy followed by a minimum of 12 weeks ICI treatment (main analysis of the trial). Tedopi® demonstrated a favorable benefit/risk ratio versus standard of care (SoC) docetaxel or pemetrexed in advanced HLA-A2+ NSCLC patients with secondary resistance to ICI.

The main results were:

Improved efficacy

  1. Overall survival (primary endpoint) was statistically significantly improved for Tedopi®: HR=0.59 (95% CI: 0.38, 0.91) in favor of the Tedopi® arm, reduced risk of death by 41%.44.4% overall survival rate at 1 year with Tedopi® versus 27.5% with chemotherapy. A clinically meaningful gain in median overall survival of 3.6 months in favor of the Tedopi® arm with Tedopi® OS at 11.1 months versus 7.5 months for SoC (p=0.017).
  1. Post progression survival was also significantly longer in the Tedopi® arm (7.7 months versus 4.6 months; p=0.004, HR=0.46).

Improved safety profile and Quality of Life

  1. The ECOG performance status(2), of maintained general health condition with time to ECOG deterioration was significantly longer in the Tedopi® arm (9.0 months versus 3.3 months; p=0.006; HR=0.43).
  2. A better quality of life was observed with Tedopi® (p= 0.04). (Global health status: p=0.045; Role Functioning: p=0.025).
  3. A good tolerance profile of Tedopi® with fewer Severe Adverse Events grade 3-5 (Tedopi® 38% vs SoC 68%, p<0.001). No Treatment Emergent Adverse Effects of concern in the Tedopi® arm.

(1)  Secondary resistance is defined as failure after a minimum of 12 weeks of Immune checkpoint inhibitor given in sequential chemotherapy –  checkpoint inhibitors treatment (Kluger HM et al; Journal for immunoTherapy of Cancer 2020 Defining tumor resistance to PD-1 pathway blockade: recommendations from the first meeting of the SITC Immunotherapy Resistance Taskforce) 

(2)  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).

These positive clinical results in a clearly-defined target population for this first Phase 3 trial are based on a strong biological rationale: increased specific T-cell responses induced by Tedopi®’s innovative mechanism of action correlated to the overall survival in HLA-A2+ NSCLC patients. The direct activation of tumor specific T-cells by Tedopi® differs from ICI releasing the break of immune response.

Tedopi® is also being investigated in other Phase 2 trials:

  • In NSCLC, in combination with Opdivo® (nivolumab), under the sponsorship of the Italian Foundation FoRT
  • In pancreatic cancer, under the sponsorship of cooperative group in oncology GERCOR
  • In ovarian cancer, in combination with Keytruda® (pembrolizumab) under the sponsorship of cooperative group in oncology ARCAGY-GINECO


Tedopi® is being evaluated in three major cancer indications:

  • Non-Small Cell Lung Cancer (NSCLC) after checkpoint inhibitor failure

The Atalante-1 clinical trial of Tedopi® evaluated the benefit of the product in an HLA-A2 positive patient population with NSCLC at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following checkpoint inhibitor failure. The Tedopi® treatment was compared to docetaxel or pemetrexed chemotherapy (CT) treatments in this patient population, with overall survival as the primary endpoint of the trial.

Clinicaltrials.gov: NCT02654587

A confirmatory Phase 3 study with a companion diagnostic strategy is under preparation to support the registration of Tedopi® as a potential new standard of care in second line for non-small cell lung cancer (NSCLC) patients in secondary resistance to immune checkpoint inhibitors (ICI) based on positive regulatory advice from FDA and EMA.


Phase 2 in NSCLC in combination with Opdivo® (nivolumab) (sponsor FoRT)

This three-arm Phase 2 study evaluates neo-epitope-based vaccine Tedopi® in combination with Bristol Myers Squibb’s Opdivo® (nivolumab), an immune checkpoint inhibitor, or Tedopi® in combination with chemotherapy versus chemotherapy alone as second-line treatment in HLA-A2 positive patients with metastatic NSCLC after first-line chemo-immunotherapy. The primary endpoint of the study is the 1-year survival rate.

Clinicaltrials.gov: NCT04884282


  • Phase 2 in pancreatic cancer (sponsor GERCOR)

The Phase 2 study TEDOPaM aims at comparing Tedopi® in combination with FOLFIRI chemotherapy versus FOLFIRI, in maintenance treatment after treatment with FOLFIRINOX. The primary endpoint of the trial is the one-year survival rate.

Clinicaltrials.gov : NCT03806309


  • Phase 2 in ovarian cancer, in combination with Keytruda® (sponsor ARCAGY-GINECO)

The three-arm TEDOVA Phase 2 study evaluates Tedopi® as a maintenance treatment, alone or in combination with the anti-PD-1 Keytruda®, versus the best supportive care in platinum-sensitive recurrent ovarian cancer patients, with controlled disease after platinum-based chemotherapy. The primary endpoint of the study is the progression free survival rate.

Clinicaltraisl.gov: NCT04713514


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