On June 6, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported a poster and a publication in abstract book featuring Tedopi, an immunotherapy activating tumor specific T-cells, in non-small cell lung cancer (NSCLC) and in ovarian cancer at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held June 2 – 6 (Press release, OSE Immunotherapeutics, JUN 6, 2023, View Source [SID1234632542]).
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ADDITIONAL DATA FROM THE POSITIVE PHASE 3 CLINICAL TRIAL IN NSCLC, ATALANTE-1
The publication- abstract "# e21037", "Prognostic factors of overall survival (OS) in non-small cell lung cancer (NSCLC) patients after failure on immune checkpoint inhibitors (IO) treated with anticancer vaccine OSE2101 or chemotherapy (CT) in phase 3 ATALANTE-1 randomized trial", reported an analysis performed to identify the prognostic factors of overall survival (OS) in each treatment group of the Phase 3 clinical trial of Tedopi (Atalante-1) in HLA-A2+ patients with advanced or metastatic non-small cell lung cancer (NSCLC), led by Pr. Benjamin Besse, Gustave Roussy cancer center, Principal Investigator of the study.
Tedopi is the first cancer vaccine that has shown 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 immune checkpoint inhibitors in advanced or metastatic NSCLC (Phase 3 trial ATALANTE-1). Classical baseline factors (disease stage, histology) and treatment effect including best response, safety and ECOG* Performance Status (PS) deterioration were studied in this analysis and correlated to OS.
The analysis concludes that prognostic factors of OS differ between the cancer vaccine Tedopi and the standard chemotherapy treatment. The maintenance of a good ECOG PS was associated with longer survival for Tedopi, and the best response to treatment was the main prognostic factor for chemotherapy. These results support the mechanism of action of Tedopi in improving OS by controlling tumor growth regardless of best response.
Dr. Silvia Comis, Head of Clinical Development of OSE Immunotherapeutics, commented: "Following the positive results presented at the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) 2022, these additional data showing how Tedopi improves OS strengthen the data basis to better understand the benefit of Tedopi on OS in NSCLC patients with secondary resistance to anti-PD-1 treatments. We look forward to advancing the clinical development of Tedopi in second line through a confirmatory pivotal Phase 3".
TEDOVA PHASE 2 CLINICAL TRIAL IN OVARIAN CANCER
The poster entitled, "TEDOVA/GINECO-OV244b/ENGOT-ov58 trial: Neo-epitope-based vaccine OSE2101 alone or in combination with pembrolizumab vs best supportive care (BSC) as maintenance in platinum-sensitive recurrent ovarian cancer with disease control after platinum", presented by Dr. Alexandra Leary, from Gustave Roussy cancer center (Villejuif, France) and Principal Investigator of TEDOVA study, featured the ongoing Phase 2 international randomized open-label clinical trial, sponsored and conducted by ARCAGY-GINECO (Poster Bd # 310a).
Dr Alexandra Leary commented: "Our patients with ovarian cancer do not respond to checkpoint inhibitors alone as these tumors are ‘immune cold’, not likely to trigger a strong immune response and usually not responding to immunotherapy. The objective of TEDOVA is to turn ovarian cancer into an ‘immune hot’ tumor by using Tedopi, a combination of tumor associated neo-epitopes that have been optimized to break immunological self-tolerance. TEDOVA is the first trial evaluating such an innovative approach in ovarian cancer. We thank the international gynecological oncology community for their support and enthusiasm in promoting and conducting this research, moreover, helping to better understand this particularly aggressive disease."
* 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).
PRESENTATION DETAILS
"Prognostic factors of overall survival (OS) in non-small cell lung cancer (NSCLC) patients after failure on immune checkpoint inhibitors (IO) treated with anticancer vaccine OSE2101 or chemotherapy (CT) in phase 3 ATALANTE-1 randomized trial." [NCT02654587]
Benjamin Besse, Paris-Saclay University, Institut Gustave Roussy, Villejuif, France
– Date: June 4, 8:00 – 11:00 am CET
– Abstract # e21037
– Session Type: Publication Only
– Session Title: Publication Only: Lung Cancer—Non-Small Cell Metastatic
– Track: Lung Cancer
– Sub Track: Non-Small Cell Lung Cancer – Advanced/Metastatic Disease
"TEDOVA/GINECO-OV244b/ENGOT-ov58 trial: Neo-epitope-based vaccine OSE2101 alone or in combination with pembrolizumab vs best supportive care (BSC) as maintenance in platinum-sensitive recurrent ovarian cancer with disease control after platinum." [NCT04713514]
Alexandra Leary, Gustave-Roussy Cancer Campus, Villejuif, and GINECO, Paris, France
– Date: June 5, 1:15 – 4:15 pm CET
– Abstract # TPS5618
– Poster Bd # 310a
– Session Type: Poster Session
– Session Title: Gynecologic Cancer
– Track: Gynecologic Cancer
– Sub Track: Ovarian Cancer
ABOUT NON-SMALL CELL LUNG CANCER
Lung cancer is the leading cause of cancer mortality (18.0% of the total cancer deaths) with an estimated 2.2 million new cancer cases per year and with 1.8 million deaths. Lung cancer is the second most commonly diagnosed form of cancer after prostate cancer in men, and the third one in women, after breast and colorectal cancers. Among this population, 85% of lung cancer fall into the non-small cell lung cancer (NSCLC) form. About 58% are diagnosed at metastatic stage with a 5-year survival rate at 7%. Patients with HLA-A2 positive NSCLC represent 45% of this population. Over half of the patients will eventually develop secondary resistance to ICIs. Median overall survival after failure to immunotherapy is low with significant adverse events, thus a high unmet need for innovative therapeutic strategies to improve patient outcomes and enhance their quality of life. The targeted population for Tedopi in second line could be estimated up to 100,000 patients per year in 7 major markets across the US, Europe, China and Japan.
ABOUT OVARIAN CANCER
Worldwide, ovarian cancer is the seventh most common cancer and the eighth leading cause of cancer death in women. The five-year survival rate for ovarian cancer worldwide is 30-40%. In 2020, there were nearly 313,000 new cases diagnosed*. Once the first relapse has occurred, ovarian cancer is managed as a chronic disease, requiring iterative lines of platinum-based chemotherapy. After 6 cycles, chemotherapy is stopped and one of the major priorities is to extend "chemotherapy-free" intervals for the patients by proposing maintenance strategies with targeted therapies (PARP inhibitors or bevacizumab). By the time patients with ovarian cancer present with first or second relapse, they will have received BOTH a PARP inhibitor and bevacizumab, thus patients progressing post-PARP inhibitors and bevacizumab represent an area of unmet medical need, they are offered chemotherapy alone with no maintenance strategy. The TEDOVA trial adresses these women.