On March 1, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) reported that the Spanish Drug Agency (Agencia Espanola de Medicamentos y Productos Sanitarios, AEMPS) has made available a new early access program that will allow access to Tedopi through a Special Situation Authorization(1) in the treatment of advanced or metastatic non-small cell lung (NSCLC) after immune checkpoint inhibitor (ICI) failure (Press release, OSE Immunotherapeutics, MAR 1, 2023, View Source [SID1234628019]). This Special Situation Authorization is based on the positive clinical data from the initial phase 3 trial of Tedopi (ATALANTE-1) in third line treatment and the high unmet need for these patients.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Tedopi is the first cancer vaccine to show positive and clinically meaningful efficacy results with significant gain in survival associated with a better safety and quality of life profile in advanced NSCLC patients, administered in monotherapy versus active comparator (chemotherapy-based standard of care), in third line with secondary resistance to immune checkpoint inhibitor (ICI).
OSE Immunotherapeutics is committed to provide Tedopi through early access and compassionate use programs across European countries to address patients’ needs alongside physicians’ engagement. Patients can benefit from Tedopi through compassionate use programs in third or further lines of treatment (post chemotherapy and immunotherapy) currently approved in France and Italy.
In Spain, following the earlier nominative compassionate use program for patients that were included in the phase 3 ATALANTE-1 trial, the Health Authorities are now expecting applications for the early access to Tedopi through an unlimited Special Situation program, confirming thereby the significant medical need for new therapeutic alternatives in this patient population.
Dr. Santiago Viteri, investigator in ATALANTE-1 study and Medical Director of UOMI Cancer Center, Clinica Mi Tres Torres, Barcelona, comments:
"The decision of the Spanish Health Agency to approve Tedopi under a Special Situation Authorization for use will facilitate early access to treatment until Marketing Authorization and represent a significant benefit for patients in third line in secondary resistance post-sequential chemotherapy and immunotherapy. Indeed, there is a high unmet need for these patients as there are no therapeutic options yet approved after failure to immunotherapies and last resort chemotherapies are associated with multiple side effects and a poor quality of life."
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "Following the positive recommendations from the US Food and Drug Administration (FDA) "Type C" meeting and the European Medicines Agency (EMA) scientific advice, OSE Immunotherapeutics is continuing the clinical development for Tedopi in second line treatment to support its regulatory registration in secondary resistance to immunotherapy. We are preparing a new confirmatory phase 3 clinical trial versus standard of care for HLA-A2+ patients in advanced in non-small cell lung cancer (NSCLC)."
(1) The Special Situation Authorization (Real Decreto 1015/2009) is intended to provide early access to medicines for patients with a severe or rare disease with high unmet need and for which no authorized therapeutic alternatives available.