Preoperative immunotherapy in early stage NSCLC safe and feasible

Both the phase 2 IONESCO and the phase 2 PRINCEPS trial evaluated adjuvant immunotherapy in patients with early-stage, resectable, non-small cell lung cancer (NSCLC). Neoadjuvant immunotherapy was shown to be feasible, safe, and not to delay or compromise surgery.

In the IONESCO trial, 50 patients with early-stage NSCLC were included (IB ≥4 cm – IIIA, non N2). The patients were treated with 3 courses of durvalumab (750 mg, day 1, 15, 29). Surgery was scheduled between day 2 and 14 after the last infusion [1]. In the PRINCEPS trial, 30 patients were included (I > 2cm - IIIA, non N2). Patients received 1 injection of atezolizumab (1,200 mg). Surgery was scheduled in week 4 after the atezolizumab treatment [2].

In IONESCO, 46 patients received neoadjuvant treatment of whom 43 went into surgery without any delay. Overall, 41/46 patients in IONESCO (89.1%) had complete surgical resection (R0); 4 (8.7%) had partial radiological response (RECIST 1.1), and 36 (78.3%) stable disease; 8 patients (18.6%) had major pathological response (<10% residual viable tumour cells). After one year, 89.1% of the patients in IONESCO were still alive; 78.2% had not relapsed.

In PRINCEPS, all patients had their surgery as scheduled. In total, 29/30 (97%) patients had complete surgical resection; 2 (7%) patients showed partial radiological response (RECIST 1.1), and 27 (93%) had stable disease; 4 (14%) patients had major pathological response (<10% residual viable tumour cells) and 12 patients (41%) had pathological response (<50% viable tumour cells). There was no correlation between radiological and pathological response. However, there was a correlation between pathological response and PD-L1 expression at baseline.

1. Wislez M, et al. Neoadjuvant durvalumab in resectable non-small cell lung cancer (NSCLC): Preliminary results from a multicenter study (IFCT-1601 IONESCO). ESMO 2020 Virtual Meeting, abstract 1214O.
2. Besse B, et al. SC Neoadjuvant atezolizumab (A) for resectable non-small cell lung cancer (NSCLC): Results from the phase II PRINCEPS trial. ESMO 2020 Virtual Meeting, abstract 1215O.

Posted on 25 November 202024 November 2020