These 10 neo-epitopes generate a specific response from the T cytotoxic cells against the malignant cells, which express at least one of these tumorous antigens. The selected epitopes are chemically optimized and combined to avoid any phenomenon of immune tolerance. Tedopi® is a personalized treatment for HLA-A2+ patients, a key receptor for the cytotoxic T-immune response.
The goal is to stabilize the development of the disease and to extend patients’ lives.
OSE Immunotherapeutics Partners with Oncology Physician Network GERCOR to Conduct a Combination Phase 2 Trial of Tedopi® for Pancreatic Cancer
In September 2017, OSE Immunotherapeutics and GERCOR, an independent non-profit French network of cancer specialists, announced their agreement to study Tedopi® in locally advanced or metastatic pancreatic cancer. This is a Phase 2 trial of maintenance therapy with Tedopi® alone or in combination with a PD-1 checkpoint inhibitor versus Folfiri*, in patients with stable disease after four months of standard chemotherapy with Folforinox** (View the press release).
* Folfiri: chemotherapy combining folinic acid, fluorouracil and irinotecan
** Folfirinox: chemotherapy combining folinic acid, fluorouracil, irinotecan and oxaliplatin
FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer; Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Becouarn Y, et al. Folfirinox versus Gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011;364:1817-25
Phase 3 clinical trial in advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
Data from the Phase 2 clinical trial showed that Tedopi® was effective in treating NSCLC by increasing patients’ relative survival rate.
Tedopi® is in a Phase 3 study, Atalante 1, in Europe and the U.S. The study is aimed at evaluating the benefits of Tedopi® as compared to current standard chemotherapies (docetaxel or pemetrexed, both approved in 2nd line treatment) in HLA-A2 positive patients diagnosed with stage IIIB (locally advanced) or IV (metastatic) NSCLC.
In June, 2017, the company decided to temporarily halt patient enrolment in the Phase 3 clinical trial while continuing treatment for patients with advanced and metastatic cancer already enrolled. The decision was based on an emerging benefit/risk balance of the experimental treatment until a complementary review of more mature clinical data (View the press release).
In December 2017, OSE has announced that the Independent Data Monitoring Committee (IDMC) had recommended to the trial’s steering committee that accrual of the Tedopi® Phase 3 trial in NSCLC could resume with a specified new recruitment strategy focused on a subgroup of patients who have failed a previous treatment with PD-1/PD-L1 immune checkpoint inhibitors (ICI). The PD-1/PD-L1 ICI class is becoming a new standard of care for patients with advanced NSCLC, demonstrating efficacy versus chemotherapy in first- and second-line treatment (View the press release).
Following formal approval from the Competent Authorities, patient accrual will resume exclusively in the group previously defined in the protocol: patients who have previously failed an ICI treatment. This patient group represents a specific population for which there are currently no approved treatment options, and for which a significant clinical need exists.
The IDMC’s most recent recommendation also includes maintaining the hold on accrual of patients who have not received prior treatment with immune checkpoint inhibitors.
Tedopi® in NSCLC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and is a Personalized Medicine in Europe in HLA-A2 positive patients.
OSE Immunotherapeutics Siège social
22, boulevard Benoni Goullin
Tel. :+33 (0)2 28 29 10 10 email@example.com
En poursuivant votre navigation sur ce site, vous acceptez l’utilisation de cookies pour réaliser des statistiques anonymes de visites. Vous pouvez vous y opposer en les désactivant. Pour cela, vous devez cliquer sur "NON".