*3.1. E*ffi*cacy*

The Italian cohort is the largest reported group from the nivolumab EAP [6,7]. Inclusion criteria included CS IIIB/IV NSCLC, ECOG 0–2, adequate organ function, life expectancy of at least 6 weeks, and progression after at least one line of systemic treatment for advanced or metastatic disease. Patients with progression within 6 months after radical treatment for locally advanced disease were also eligible. Unstable brain metastases and active known or suspected autoimmune disease (with some exceptions) were contraindications for nivolumab treatment. For 1588 patients with non-squamous NSCLC, the median OS was 11.3 months, the 1-year OS rate was 48%, and the median PFS was 3.0 months, with a 1-year PFS rate of 22% [6]. The median OS was 7.9 months and the 1-year OS rate was 39% in the 371 patients with squamous NSCLC [7]. The overall response rate (ORR) was 18% for both the squamous and non-squamous NSCLC patient groups. Similar efficacy data from other countries are also available. In a group of 901 Japanese patients treated in an observational post-registration study, the median OS was 14.6 months for the entire patient population and the 1-year OS rate was 54.3% [8]. The median OS was 15.1 months for patients with non-squamous NSCLC and 12.3 months for patients with squamous NSCLC [8]. The median PFS for the entire patient population was 2.1 months and the ORR was 20.5% [8]. Survival and ORR data reported in other publications (patients in the EAP and in routine clinical practice) are summarized in Table 2.


**Table 2.** Survival in patients treated with nivolumab in real-world practice.

OS—overall survival, PFS—progression-free survival, ORR—overall response rate, NR—not reached, na—not applicable, nd—no data, HR—hazard ratio. \* 49/260 patients were evaluated for response,

\*\* Statistically non-significant.
