Home » Immunotherapy for the most aggressive lung cancer: efficacy confirmed even outside clinical trials

Immunotherapy for the most aggressive lung cancer: efficacy confirmed even outside clinical trials

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Immunotherapy for the most aggressive lung cancer: efficacy confirmed even outside clinical trials

USELESS to go around too much. Small cell lung cancer (SCLC) still represents a major challenge for clinical oncology. Unfortunately, for those who fall ill, there are still few treatment options. However, after two decades without substantial therapeutic advances, the advent of immunotherapy has begun to change things, opening openings for modifying the clinical history of the disease. He tells it to Salute Emilio BriaHead of the Simple Departmental Unit of Thoraco-Pulmonary Oncology at the Agostino Gemelli IRCCS University Hospital in Rome and Associate Professor of Medical Oncology at the Catholic University of the Sacred Heart, co-head of a study made in Italy which is confirming the good safety and efficacy profile of the immunotherapy atezolizumab in combination with chemotherapy also in the so-called context of Real Lifei.e. in a more diverse patient population than in the pivotal clinical trials.

What changes between registration studies and clinical practice

Atezolizumab in combination with carboplatin and etoposide chemotherapy is a therapy approved in Italy since 2020 for the first-line treatment of patients with ‘extensive’ stage SCLC, i.e. advanced and spreading beyond the chest. The regulatory clearance and reimbursement came after positive results from the pivotal Impower133 clinical trial, which was the first to show a significant survival benefit.

However, as Bria explains, there may be a gap between the patient population involved in pivotal clinical trials (i.e. those that are conducted prior to the approval of a new cancer treatment in accordance with regulatory authorities) and that which an oncologist would faces in everyday clinical practice once the drug is made available. “Registration clinical trials have very stringent inclusion criteria, but the number of patients for whom a given treatment can be delivered with potential efficacy in clinical practice is wider”, explains Bria. Disease characteristics, medical history and overall state of health can in fact be more varied. Therefore, it is important to evaluate treatment performance in a patient population more similar to that of real life.

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Lo the study of Maurice

“It was precisely for this purpose that we designed the Mauris study”, confirms Bria, “A phase IIIB study involving 155 patients in 25 Italian centres, which overlaps in terms of therapeutic regimen with the experimental arm of the Impower133 pivotal study, and which, in addition to consider the prognostic aspect, i.e. the efficacy of atezolizumab in combination with chemotherapy in patients with advanced SCLC, also evaluate how patients tolerate this innovative therapeutic regimen in clinical practice”.

In the Mauris study, patients were treated with carboplatin, etoposide, and atezolizumab for 4 to 6 cycles in the lead-in phase, followed by atezolizumab maintenance until progression or unacceptable toxicity. The first data, presented at the ESMO 2022 congress, are in line with those of the pivotal study, with an estimated overall survival expected and a tolerability profile similar to that obtained in the Impower study133. Specifically, adverse events (of which 17-18% serious) occurred in about one third of patients, while immune-mediated events (of which 7% serious) occurred in 13-14% of patients, confirming the data already present in the literature for immunotherapy.

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Future prospects

“Approximately 40% of patients treated with atezolizumab survive for more than one year, a result which confirms the effectiveness of the therapeutic scheme even in a population more similar to that of daily clinical practice”, explains Bria. “The study also opened up the possibility that continuing chemotherapy treatment up to 6 total cycles – an option that was not allowed in the pivotal study – could produce a prognostic advantage”. The results of the Mauris study therefore pave the way for future research developments, including the search for predictive biomarkers of response to immunotherapy in SCLC. “We plan to explore innovative aspects, such as the association between treatment efficacy and safety with patients’ molecular and genetic characteristics,” concludes Emilio Bria. “The challenge is to understand if there are selection factors that allow us to identify patients who derive greater benefit from the addition of immunotherapy”.

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