OSE Immuno and its clinical partners GERCOR, ARCAGY-GINECO and the FoRT Foundation (Fondazione Ricerca Traslazionale) presented four posters about the combination of neo-epitopes Tedopi in several oncological indications at the annual meeting ASCO (American Society of Clinical Oncology of the Year) 2022). ASCO) Annual Meeting), which took place from 4 to 7 June.
-In non-small cell lung cancer (NSCLC) in patients with HLA-A2 + after failure of immune inhibitor checkpoints: final data from a randomized phase 3 study
Atalante-1 was presented by Pr.Benjamin Besse (Gustave Roussy Institute, Villejuif, France).
This presentation showed significantly better outcomes reported by Tedopi® patients compared to chemotherapy in patients with secondary NSCLC resistance after failure of inhibitory checkpoints in the primary analysis (n = 118 patients). These patient-reported results and secondary endpoints were also confirmed to be significant in the sensitivity analysis (n = 219) in the overall population.
In patients with metastatic or advanced NSCLC in secondary resistance after sequential immuno-oncology after platinum-based chemotherapy who have received checkpoint inhibitors for at least 12 weeks (CT-IO in secondary resistance), Tedopi significantly improves overall survival and maintains quality of life according to data. tolerances compared to standard treatment (docetaxel or pemetrexed), in particular in terms of physical function and overall health score. Patients had fewer symptoms than those usually associated with side effects of chemotherapy.
“In a difficult-to-treat population after inhibition checkpoint failure, these patient-reported quality of life data from the Phase 3 of the Atalante 1 study add to the key positive results of the study, which demonstrated the benefits of significant survival with Tedopi over standard treatment. in NSCLC patients who have failed treatment with checkpoint inhibitors. This reinforces the rationale for the forthcoming timely access package to be submitted to regulatory agencies in 2022, ”comments Dominique Costantini, Director of OSE Immunotherapeutics.
– For pancreatic cancer poster: “Non-comparative, randomized phase II study of Tedopi therapeutic vaccine in maintenance therapy alone or in combination with nivolumab or FOLFIRI after induction treatment with FOLFIRINOX in patients with advanced pancreatic adenocarcinoma” Anthony Turpin (Lille University Hospital Center).
This presentation showed the first preliminary results of the Phase 2 study of Tedopi in metastatic or advanced pancreatic cancer. The primary endpoint was one-year survival (Fleming analysis; zero hypothesis 25%), the key secondary endpoint was the time to failure of the maintenance strategy (time to failure of the strategy = duration of maintenance + reintroduction of FOLFIRI).
Preliminary results included 29 randomized, progression-free HLA-A2 + patients after 8 cycles with FOLFIRINOX: 9 patients in standard arm A (FOLFIRI) with a one-year overall survival of 44% and a partial response (11%); 10 patients in experimental arm B (Tedopi monotherapy) with an overall one-year survival of 40% and a partial response (10%); 10 patients in arm C (Tedopi + nivolumab) with a one-year survival rate of 30% and no partial response.
Tedopi has shown a good safety profile and encouraging duration in maintenance monotherapy until the strategy fails, which justifies continuing the evaluation. The combination of nivolumab + Tedopi was associated with less favorable results, which led to the closure of this arm.
On the recommendation of the Independent Data Monitoring Committee (IDMC), the study is conducted according to a modified protocol comparing Tedopi maintenance therapy in combination with FOLFIRI versus FOLFIRI chemotherapy after FOLFIRINOX treatment.
“These first interim results for pancreatic cancer are very interesting to Tedopi for this very aggressive form of cancer, which is generally poorly predicted and for which there is a strong medical need. We would like to thank the GERCOR group of oncologists and PRODIGE an encouraging first step shared at the ASCO Congress, “commented Dominique Costantini, CEO of OSE Immunotherapeutics.
In addition, two “Ongoing Trial” poster presentations showed the design of two ongoing Tedopi clinical trials in combination with a checkpoint inhibitor, promoted and led by collaborating groups in oncology:
– Combi-TED, a study supported and led by the Italian FoRT Foundation: ‘Multicenter, open-label, randomized study II. The efficacy of Tedopi plus docetaxel or Tedopi plus nivolumab as second-line treatment in metastatic NSCLC progressing to first-line chemoimmunotherapy Federico Cappuzzo, Medical Director of Oncology at the Regina Elena Cancer Institute (Rome) and principal investigator.
-TEDOVA, a study sponsored and conducted by ARCAGY-GINECO: “A phase 2 clinical study evaluating the combination of Tedopi neoepitopes alone or in combination with pembrolizumab versus standard treatment as maintenance treatment in ovarian cancer patients in a relapsing condition is controlled by platinum and platinum chemotherapy ”), presented by Dr. Alexandra Leary, principal investigator of the TEDOVA study (Gustave Roussy, Villejuif).