OSE-2101 met the primary endpoint in the predefined Step-1 analysis of the phase III Atalante 1 trial in patients with HLA-A2 positive non–small cell lung cancer after failure of anti–PD-1/PD-L1 agents.
OSE-2101 (Tedopi) met the primary endpoint in the predefined Step-1 analysis of the phase III Atalante 1 trial in patients with HLA-A2 positive non—small cell lung cancer (NSCLC) after failure of anti–PD-1/PD-L1 agents, according to OSE Immunotherapeutics, the manufacturer of the cancer vaccine.
Despite this success, Step-2 of the trial has been cancelled due to the risks and data integrity now posed by the COVID-19 crisis.
“The company together with the Independent Data Monitoring Committee and the Steering Committee of the trial have reviewed the potential impact of the COVID-19 outbreak on the Atalante 1 trial. As of today, there is ongoing concern that trial data may be markedly impacted given the current worldwide COVID-19 pandemic and the increased risk for patients with NSCLC as COVID-19 can cause serious pulmonary complications in this immunocompromised patient population,” OSE Immunotherapeutics reported in a press release.
“In addition, recommendations from several medical societies include voluntary holds on recruitment of new patients in oncology trials for the time being, due to patient safety concerns,” the company further explained.
The halt of the promising OSE-2101 study highlights the harsh reality facing the oncology research community during the COVID-19 outbreak. Without a doubt, progress in the war on cancer is being stunted during these unprecedented times.
Earlier this month, the FDA released, “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” to provide guidance to clinical researchers during the crisis; however, there is no path for the continuation of “business as usual,” and progress will suffer in the fight against all diseases.
According to OSE, “Tedopi is a proprietary combination of 9 optimized neo-epitopes plus 1 epitope giving universal helper T-cell response targeting T-cell activation. Tedopi is a specific treatment for HLA-A2+ patients, a key receptor for the cytotoxic T-immune response.”
The 2-part phase III trial Atalante 1 (NCT02654587) was accruing patients with histologically or cytologically confirmed diagnosis of stage III NSCLC that is unsuitable for radiotherapy or stage IV NSCLC. Patients had disease recurrence or progression following treatment with an immune checkpoint inhibitor and platinum-based chemotherapy.
Step-1 of the trial assessed the preliminary efficacy of OSE-2101, and Step-2 was going to compare overall survival between a cohort of patients receiving OSE-2101 and a cohort of patients receiving docetaxel or pemetrexed.
The Step-1 analysis showed a 12-month survival rate of 46% (29 of 63 patients; 95% CI, 33%-59%) in patients receiving OSE-2101. The lower bound of the CI (33%) exceeded the predetermined threshold for futility of 25%. The survival rate also surpassed the 40% survival rate assumption that the study protocol specified for the alternative efficacy hypothesis. At the time of the analysis, an assessment of patients receiving chemotherapy showed a 12-month survival rate of 36% (13 of 36 patients).
“We are very pleased with these positive results for Tedopi in Step-1 and with a 10% absolute difference in 12-month survival rate versus chemotherapy in NSCLC patients after failure of checkpoint inhibitor treated in Atalante 1 Step-1 trial. This outcome confirms the therapeutic value of our neoepitope product in a patient population for whom there are no registered product today and who needs new therapeutic options. Based on these positive results, we are now eager to engage in discussions with regulatory authorities to evaluate Tedopi’s current clinical results and agree upon the best options for further development to maximize on the product’s positive data in terms of benefit/risk ratio. In parallel, given the significant value added by positive Step-1 results, we continue exploring potential partnership opportunities for Tedopi,” Alexis Peyroles, CEO of OSE Immunotherapeutics, said in the press release.
Phase 3 Clinical Trial of Tedopi®: OSE Immunotherapeutics Announces Positive Top-Line Results for Step-1 of its trial ‘Atalante 1’ in Non-Small Cell Lung Cancer. Published April 1, 2020. https://bit.ly/2JtRbLV. Accessed April 1, 2020.