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-immune checkpoint inhibitors (ICI) failure in advanced or metastatic NSCLC:

• Significant overall survival (primary endpoint) (p=0.017, HR=0.59) with 44.4% overall survival (OS) rate at 1 year with Tedopi® versus 27.5% for chemotherapy and a meaningful gain of median OS of 3.6 months (ESMO 2021);
• Improved post-progression survival benefit in the Tedopi® arm (7.7 months versus 4.6 months, p=0.004, HR=0.46) (ESMO 2021);
• Significant delayed median time to worsening ECOG* performance status with a difference of 5.3 months (p<0.01, HR=0.43) (ASCO 2022);
• Significant better safety profile with less severe (Grade 3-5) adverse events (11% with Tedopi® versus 35% with chemotherapy, p<0.05) (ESMO 2021);
• Significant better Quality of Life (Global health status: p=0.045; Role Functioning: p=0.025) (ASCO 2022) and positive Net Treatment Benefit (p=0.032) with Tedopi® compared to chemotherapy (ESMO 2022).

* 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

ABOUT THE TEDOPI^® CLINICAL PROGRAM

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 2^nd or 3^rd 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

OSE Immunotherapeutics is preparing a confirmatory Phase 3 pivotal trial to support the regulatory registration of Tedopi® as a new standard of care in advanced or metastatic NSCLC in secondary resistance post-ICI failure.

Press Release of  10/20/2022

Results presented at ESMO 2021

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