On February 15, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) reported a regulatory update on the clinical development plan of Tedopi, an immunotherapy activating tumor specific T-cells, in phase 3 in monotherapy in advanced or metastatic non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (ICI) (Press release, OSE Immunotherapeutics, FEB 15, 2023, View Source [SID1234627283]).

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Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments:

"We are pleased with the positive outcomes from the US Food & Drug Administration (FDA) Type C Meeting following the supportive European Medicines Agency (EMA) advice, as we are actively preparing a confirmatory phase 3 trial to support the regulatory registration of Tedopi.

Leveraging on the positive data on efficacy, safety and quality of life from the initial phase 3 randomized trial in third line post-chemotherapy followed by an immune checkpoint inhibitor (ICI), we are committed in advancing the clinical development for Tedopi as a potential new standard of care in monotherapy in second line for advanced or metastatic lung cancer patients in secondary resistance to ICI now used in first line. No therapeutic options have yet been approved to date in this patient population with high unmet medical needs."

Positive recommendations from the US Food and Drug Administration (FDA) "Type C" meeting following the European Medicines Agency (EMA) scientific advice for the confirmatory phase 3 trial in second line treatment

Both Agencies supported the continuation of the clinical development for Tedopi through a new confirmatory phase 3 clinical trial versus standard of care in second line treatment for HLA-A2+ patients in advanced in non-small cell lung cancer (NSCLC).

OSE Immunotherapeutics is thus progressing on the protocol development for the next confirmatory phase 3 pivotal trial to support the regulatory registration of Tedopi in second line. This upcoming phase 3 is planned for HLA-A2+ patients with secondary resistance to immunotherapy (IO) after a first line of chemo-IO followed by failure to maintenance IO of at least 12 weeks (defined as the threshold for secondary/acquired resistance by international expert consensus recommendations). The protocol design is developed with the support of the international NSCLC clinician experts’ group which were already involved in the previous phase 3 ATALANTE trial.

Positive clinical data from the initial phase 3 trial ATALANTE in third line treatment

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

– Significant overall survival (primary endpoint) (p=0.017) with 44.4% overall survival rate at 1 year with Tedopi versus 27.5% with chemotherapy;

– Significant better safety profile with less severe (Grade 3-5) adverse events (11% with Tedopi versus 35% with chemotherapy, p<0.05);

– Significant better quality of life (Global health status: p=0.045; Role Functioning: p=0.025).

The results from the first phase 3 trial (ATALANTE) in a clearly defined target population 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.

Ongoing compassionate use* programs in third line treatment in secondary resistance post-sequential chemotherapy and immunotherapy

OSE Immunotherapeutics is committed to provide Tedopi through cohort early access and nominative compassionate use programs across European countries to address patients’ needs alongside physicians’ engagement.

The French National Authority for Health issued a negative decision on the cohort early access program in third line treatment related to the COVID crisis which led to the suspension of patient inclusion in the previous phase 3 ATALANTE and the consecutive primary analysis on a population of interest with secondary resistance.

Patients can benefit from Tedopi through compassionate use programs in third or further lines of treatment (post chemotherapy and immunotherapy) currently approved in France, Italy and Spain, confirming thereby the significant medical need for new therapeutic alternatives.

On-going combination studies of Tedopi

Tedopi is currently being evaluated in phase 2 combination trials in three indications:

– Non-Small Cell Lung Cancer: Tedopi plus docetaxel or Tedopi plus nivolumab or docetaxel alone, in second-line treatment in metastatic NSCLC, progressing after first-line chemo-immunotherapy (CombiTED study: NCT04884282, 105 patients planned, sponsor: FoRT);

– Pancreatic cancer: Tedopi plus FOLFIRI vs FOLFIRI as maintenance treatment in patients with advanced or metastatic pancreatic adenocarcinoma with no progression after 8 cycles of FOLFIRINOX (TEDOPaM study: NCT03806309, 106 patients planned, sponsor: GERCOR);

– Ovarian cancer: Tedopi alone or in combination with pembrolizumab vs best supportive care as maintenance treatment in platinum-sensitive recurrent ovarian cancer patients (TEDOVA study: NCT04713514, 180 patients planned, sponsor: ARCAGY-GINECO).

* Compassionate use is a treatment option that allows for the use of an unauthorized medicine. Under strict conditions, products in development can be made available to nominative patients who have a disease with no satisfactory authorized therapies and who cannot enter clinical trials (https://www.ema.europa.eu/en/human-regulatory/research-development/compassionate-use).