Green light from the European Commission for immunotherapy against early stage lung cancer

Green light from the European Commission to the immunotherapy atezolizumab as adjuvant treatment, after complete resection and platinum-based chemotherapy, for adult patients with non-small cell lung cancer (Nsclc) at high risk of relapse, whose tumors express a Pd level -L1 greater than or equal to 50%, and which do not have Nsclc with Egfr or Alk-positive mutation. This was announced by Roche, underlining that atezolizumab thus becomes “the first and only anticancer immunotherapy approved in Europe for the treatment of some types of early stage Nsclc”. Atezolizumab – the company also informs – has also received the approval of the Italian drug agency Aifa for the extension of use as monotherapy for the first-line treatment in metastatic Nsclc with high expression of Pd-L1. This further extension of indication makes atezolizumab “the first and only single-agent immunotherapy against lung cancer, available in three dosages, which allow administration every 2, 3 or 4 weeks, with a significant advantage in terms of treatment management flexibility. for doctors and patients “.” We are facing a double goal for patients with non-small cell lung cancer – says Filippo de Marinis, director of the Thoracic Oncology Division of the European Institute of Oncology (Ieo) in Milan – On the one hand, Italian patients with advanced Nsclc can already take advantage of atezolizumab, thanks to the recent approval by Aifa of the extension of indication for the first-line treatment of metastatic stage carcinoma with high Pd-L1 expression. This result is the result of the IMpower110 study, which showed a significant improvement in the overall survival (Os), with a decrease of 3 1% risk of death and over 60% of patients alive at 1 year. The consolidated clinical experience thanks to the use of this molecule also in other therapeutic areas, together with the efficacy and safety profiles, are factors that differentiate the opportunity to have atezolizumab today also in the first line of treatment. In addition to this Italian approval, the European approval opens the way for the treatment of the disease at an early stage, with the promising outcomes of the IMpower010 study for the treatment of NSCLC in the adjuvant setting, an area currently characterized by a strong ‘unmet need’. The phase III results show that atezolizumab halves the risk of relapse or death in patients with Nsclc stage II-III, compared to standard of care. “The European approval – details a note – is based on the results of an analysis to interim of the phase III IMpower010 study. Results demonstrated that treatment with atezolizumab, following complete resection and platinum-based chemotherapy, reduced the risk of disease recurrence or death (Dfs) by 57% in patients with resected Nsclc. stage II-IIIA with expression of a PD-L1 level ≥50%, without Egfr or Nsclc Alk-positive mutations, compared to best supportive care (Bsc). In most subgroups, including histology or stage disease, a benefit in terms of Dfs was found with adjuvant atezolizumab, compared to Bsc. ia with Egfr or Alk-positive mutations, are still incomplete and have not been formally analyzed in the interim analysis of the Dfs; however, a trend towards improvement in Os was observed with atezolizumab. The follow-up will continue with the scheduled analyzes of the most updated OS data during the year. The safety data of atezolizumab are consistent with the known safety profile and no new safety signals have been identified. “Having atezolizumab as adjuvant therapy is an important step forward for patients with early Nsclc, a setting in which Unfortunately, the recurrence rates are still very high, despite surgery aimed at healing – comments Lorenzo Spaggiari, director of the Ieo Thoracic Surgery Division – In addition to the fundamental work in tandem between oncologist and surgeon for multidisciplinary evaluation, it is important to be able to identify patients in early stage, so as to arrive at an early diagnosis and intervene promptly before an advanced stage, even if to date there is no structured screening for lung cancer, unlike other oncological pathologies “.