Advances in the treatment of early-stage lung cancer. The European Commission has in fact approved the immunotherapy molecule pembrolizumab (a monoclonal antibody) in combination with platinum-based chemotherapy, as a neoadjuvant treatment (before surgery), continued in monotherapy as an adjuvant treatment (after surgery), for breast cancer resectable non-small cell lung cancer (NSCLC), at high risk of recurrence in adults. This was announced by the pharmaceutical company MSD, specifying that the approval follows the positive recommendation of the Committee for Medicinal Products for Human Use obtained in February 2024 on the basis of the results of the Phase 3 Keynote-671 study.
The decision, the note specifies, represents the first approval in Europe of an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results and constitutes the sixth approval of pembrolizumab in lung cancer in Europe. At a median follow-up of 29.8 months, pembrolizumab plus chemotherapy in the neoadjuvant setting followed by pembrolizumab monotherapy after surgical resection significantly improved overall survival (OS), reducing the risk of death by 28% in patients with stage resectable NSCLC. II, IIIA, or IIIB versus placebo plus chemotherapy in the neoadjuvant setting followed by placebo after surgical resection, regardless of Pd-l1 expression.
In 2023, in Italy, approximately 44 thousand new diagnoses of lung cancer were estimated. “Despite the progress recorded in the metastatic stage, lung cancer continues to represent the main cause of death from cancer in Italy, confirming the need to treat patients in the early stages of the disease, for which it is truly possible to obtain the best therapeutic and have ambitious treatment objectives – explains Silvia Novello, Professor of Medical Oncology at the University of Turin and Head of Pulmonary Oncology at the San Luigi Gonzaga Hospital in Orbassano -. The approval of the pembrolizumab-based regimen constitutes an important milestone for patients diagnosed with resectable non-small cell lung cancer, but still at risk of recurrence, offering a new therapeutic option that has been shown to help prolong life. We hope that all eligible patients who find themselves in this condition of illness can have access to and benefit from this treatment as soon as possible also in Italy”.
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