Tolerability and antitumor activity of cemiplimab, a human monoclonal anti-PD-1, as monotherapy in patients with pretreated non-small cell lung cancer (NSCLC): data from the Phase 1 NSCLC expansion cohort
Mené sur 20 patients atteints d'un cancer du poumon non à petites cellules de stade avancé (âge médian : 64 ans), cet essai de phase I évalue la toxicité et l'efficacité, du point de vue du taux de réponse, du cémiplimab en monothérapie (un anticorps anti-PD-1), après l'échec de lignes de traitements systémiques (nombre médian de thérapies antérieures : 2 ; durée médiane de suivi : 7 mois)
Résumé en anglais
Objectives : Blockade of programmed cell death-1 (PD-1) and its ligand (PD-L1) has transformedthe treatment of NSCLC. In a first-in-human, Phase 1, dose escalation and cohort expansionstudy, cemiplimab, a monoclonal antibody directed against PD-1, was evaluated forthe treatment of patients with advanced solid tumors (NCT02383212). Here, we reportresults in patients with advanced NSCLC from the dose expansion cohort.
Materials and methods : Immune-checkpoint inhibitor naive patients with advanced NSCLC (stage III/IV), irrespectiveof PD-L1 status, who had progressed after, or were refractory to first- or later-linetherapy were enrolled and received cemiplimab 200 mg every 2 weeks intravenously forup to 48 weeks. Primary study objectives were to assess safety and tolerability, andto evaluate clinical activity of cemiplimab.
Results : Twenty patients with NSCLC were enrolled. Median age was 64.0 years (range: 50‒82);65.0% were male; 80.0% had an ECOG performance status of 1; 60.0% had a histologyof adenocarcinoma. Median number of prior lines of systemic therapy was 2 (range:2)1–4). Median duration of follow-up was 7.0 months (range: 1.0–18.2). All patientsexperienced ≥1 treatment-emergent adverse event (TEAE) of any grade. Most common TEAEswere arthralgia, asthenia, cough, and dyspnea (each 4/20; 20.0%). Grade ≥3 TEAEs occurredin 60.0% (12/20) of patients. Of patients with measurable disease per independentcentral review (ICR), five had partial response (PR), four had stable disease (SD)and 10 had progressive disease. Objective response rate (ORR; complete response + PR)was 25.0% (95% CI: 8.7–49.1%). Duration of response exceeded 8 months in four of thefive responding patients at the time of data cut-off (April 30, 2019). The diseasecontrol rate per ICR (ORR + SD) was 50.0% (95% CI: 27.2–72.8%).
Conclusion : Cemiplimab showed an acceptable safety profile and demonstrated antitumor activity in pretreated patients with NSCLC.
