On September 20, 2021 OSE Immunotherapeutics reported that the positive final results of its Phase 3 trial of neoepitope-based cancer vaccine Tedopi, called Atalante 1, in HLA-A2 positive patients with advanced non-small cell lung cancer (NSCLC) after immune checkpoint inhibitor (PD-1/PD-L1) failure, were presented in a late-breaking oral presentation(1) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress being held on September 16 – 21, 2021 (Press release, OSE Immunotherapeutics, SEP 20, 2021, View Source [SID1234646971]).
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Pr. Benjamin Besse, Director of Clinical Research at Gustave Roussy (Villejuif, France), and Principal Investigator of the Atalante 1 study, commented: "There was a lot learned during this trial about Tedopi and its potential clinical benefit that will help inform future studies in the immunotherapy field. Applying the 2020 SITC (Free SITC Whitepaper)(2) guidelines defining resistance categories for PD-1/PD-L1 checkpoint inhibitors to our trial, developed while this trial was ongoing, suggest there is great potential for Tedopi in patients with secondary resistance(3) . Therefore, we are very pleased to share such very promising results demonstrating the substantial benefits of Tedopi for NSCLC patients with secondary resistance to anti-PD-1 treatments, a hard to treat patient population with high medical need."
The Atalante 1 clinical trial evaluated the benefit of Tedopi in an HLA-A2 positive patient population with NSCLC at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following checkpoint inhibitor failure. The Tedopi treatment was compared to docetaxel or pemetrexed chemotherapy (CT) treatments in this patient population, with overall survival as the primary endpoint of the trial.
The Atalante 1 clinical trial evaluated the benefit of Tedopi in an HLA-A2 positive patient population with NSCLC at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following checkpoint inhibitor failure. The Tedopi treatment was compared to docetaxel or pemetrexed chemotherapy (CT) treatments in this patient population, with overall survival as the primary endpoint of the trial.
A total of 219 patients were enrolled in Atalante 1. 183 (84%) of these patients received sequential CTimmunotherapy (IO), of which 118 patients (54%) met the definition of PoI, with otherwise similar other baseline characteristics to the overall Atalante 1 population.
Tedopi demonstrated a favorable benefit/risk ratio versus standard of care (SoC) docetaxel or pemetrexed in advanced HLA-A2+ NSCLC patients with secondary resistance to immune checkpoint inhibitors.
The main results were:
Improved efficacy
1. Overall survival (primary endpoint) was statistically significantly improved for Tedopi: HR=0.59 (95% CI: 0.38, 0.91) in favor of the Tedopi arm. A clinically meaningful gain in median overall survival of 3.6 months in favor of the Tedopi arm with Tedopi OS at 11.1 months versus 7.5 months for SoC (p=0.017).
2. The objective response rate and progression free survival (PFS) were lower in the Tedopi arm, as
expected for a therapeutic vaccine versus a cytotoxic drug while at 6 months, the disease control
rate (DCR) was similar (25 % Tedopi versus 24 % SoC).
3. Post progression survival was also significantly longer in the Tedopi arm (7.7 months versus 4.6 months; p=0.004).
Improved safety profile
1. A good ECOG performance status(5), with time to ECOG deterioration significantly longer in the Tedopi arm (8.6 months versus 3.3 months; p=0.0005).
2. A maintained quality of life was observed with Tedopi (p= 0.04).
3. A good tolerance profile of Tedopi with fewer Severe Adverse Events (Tedopi 38% vs SoC 68%, p<0.001). No Treatment Emergent Adverse Effects of concern in the Tedopi arm.