The European Respiratory Society (ERS) International Congress – the world’s largest respiratory meeting – will take place online from 5-8 September, offering the latest advances in respiratory medicine and science.
MEDSIR was awarded an oral presentation and will be presenting the findings from the interim analysis of the COPERNICO trial (abstract #31057) – an investigator-initiated phase II study evaluating the combination of tocilizumab plus pembrolizumab in adult patients with Coronavirus 2019 (COVID-19) pneumonia.
Dr. Pilar Vizcarra –medical research coordinator of the infectious diseases’ unit at the Ramón y Cajal Hospital in Madrid (Spain)– is the selected speaker for this study. Along with Dr. Matilde Sanchez-Conde, from the same unit, Dr. Vizcarra contributed to the recruitment of more than 80% of patients, accelerating the set up and management of this important study.
“Thanks to an extensive expertise in the field of immune-oncology, MEDSIR translated and adapted the tremendous potential of this innovative approach designed to attack cancer cells in favor of patients affected by COVID19, positioning into the forefront of the fight against the virus.” said Dr. José Manuel Pérez García, one of the principal investigators (PI) of the study, and deputy director of International Breast Cancer Center (IBCC) in Barcelona (Spain).
The main objective of this randomized, controlled, open-label, phase II trial, is to study the safety and efficacy of tocilizumab –a monoclonal antibody directed against interleukin-6 (IL-6) receptor– in combination with pembrolizumab – an immunotherapy blocking PD-1/PD-L1 interaction on T cells – in high-risk hospitalized patients with COVID-19 pneumonia.
In the most severe cases of COVID-19, patients progress to hypoxemic respiratory failure – a syndrome in which the respiratory system lacks sufficient oxygenation – leading to death. This process is linked to a severe inflammatory response, with a rapid increase of inflammatory markers (IL-6, ferritin, and C-reactive protein among others), and a reduction in the level and functionality of T cells, which have a key role in fighting infections. We hypothesized that IL-6 receptor blockade with tocilizumab combined with the immune-activating agent pembrolizumab might interrupt this hyperinflammation, restoring the immunocompetence to a functional stage.
In COPERNICO, hospitalized patients with COVID-19 pneumonia were enrolled across 8 different sites in Spain and randomized 2:1 to receive either the combination of tocilizumab/pembrolizumab plus standard of care (SoC), or the SoC alone. The primary outcome is the time to hospital discharge, whereas secondary parameters are patients discharged by day 90, mortality through to the end of study, remission of respiratory symptoms, and adverse events.
Interestingly, at the interim analysis, treated patients in the tocilizumab/pembrolizumab +SoC group (n=7) showed a median time to hospital discharge of 10 days compared with 47.5 days of patients in the SoC group (n=5), meeting the primary objective of the study (P=0.03). All the secondary outcomes also favor the tocilizumab/pembrolizumab+SoC group in comparison to the SoC group, with higher levels of patients discharged by day 90, discharged without respiratory symptoms, and fewer adverse events of any grade.
“Findings from COPERNICO must be interpreted in the context of therapies for severe COVID-19 pneumonia that, despite the worldwide progressing of the vaccination program, remains the major challenge due to a continuous evolution of the virus to novel variants that escape the immune response”, affirmed Dr. Vizcarra, first author of the communication and member of the research team.
Despite the small number of patients, interim results from the COPERNICO trial demonstrated that thiscombined intervention has a substantial positive effect at improving outcome of adult patients with COVID-19 pneumonia, supporting further clinical investigation. “This therapeutic approach could be a key resource in the management of the most critically ill cases of COVID-19, where sometimes neither dexamethasone, remdesivir, nor other targeted immunomodulators have a significant effect on mortality,” highlighted Dr. Antonio Llombart, PI of the study and Head of Medical Oncology Service at Hospital Arnau de Vilanova (Valencia, Spain).
"We started this trial at the beginning of the pandemic, when almost no therapeutic options were available for hospitalized patients, and very little was known about this new virus,” remarked Dr. Javier Cortés, Scientific Coordinator of the study and director of IBCC. “With COPERNICO, we aimed at introducing an effective treatment for all those cases of severe COVID-19 pneumonia. Today, we really hope that the promising results obtained in this small study can pave the way for bigger trials, introducing this combination as a novel clinical standard in a severe setting”.
The study has been fully designed, sponsored and self-funded by MEDSIR. Special mentions go to all contributors to the crowdfunding campaign, in particular to Lucia Be and IEC Trials, that helped to bring our COPERNICO trial to life.
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