Tolerability and antitumor activity of cemiplimab, a human monoclonal anti-PD-1, in patients with non-small cell lung cancer (NSCLC): Interim data from a phase I dose escalation and NSCLC expansion cohort

Autor: Victor Moreno, Emiliano Calvo, Maria Eugenia Olmedo Garcia, Marta Gil-Martin, Raid Aljumaily, Kyriakos P. Papadopoulos, Lee S. Rosen, Petra Rietschel, Kosalai Kal Mohan, Jingjin Li, Elizabeth Stankevich, Tracey Rowlands, Minjie Feng, Matthew G. Fury
Rok vydání: 2019
Předmět:
Zdroj: Journal of Clinical Oncology. 37:116-116
ISSN: 1527-7755
0732-183X
Popis: 116 Background: NSCLC accounts for ~85% of lung cancers; most patients (pts) are at an advanced stage at the time of diagnosis. Cemiplimab (REGN2810) is being investigated for the treatment of NSCLC, in addition to other indications (NCT02383212). Methods: In the dose escalation (DE) phase, enrolled pts with advanced malignancies with no alternative standard-of-care therapeutic option received cemiplimab 1, 3 or 10 mg/kg every 2 weeks (Q2W) intravenously (IV) for up to 48 weeks. In the NSCLC expansion cohort (EC 1), enrolled pts with advanced disease who had relapsed after, or were refractory to at least first-line therapy received cemiplimab 200 mg Q2W IV for up to 48 weeks. Tumor biopsies were performed at baseline (EC 1 only), Day 29 and progression, if possible. Tumor measurements were performed every 8 weeks according to RECIST 1.1. Results: As of Sept 1, 2017, 21 pts with NSCLC (1 in DE at 1 mg/kg; 20 in EC 1) were enrolled; median age was 65.0 years (range, 50–82; 14 M/ 7 F); 81.0% had a ECOG performance status of 1, 19.0% of 0; 13/21 (61.9%) had a histology of adenocarcinoma. The most common treatment-related adverse events (TRAEs) were asthenia, pneumonitis, and rash (each n = 3, 14.3%). Each of the following ≥Grade 3 TRAEs occurred once: pneumonitis, diabetic ketoacidosis, and nephritis. By central independent review, 6 pts had partial response (PR), 6 had stable disease (SD) or non-complete response (CR)/non-progressive disease (PD), and 9 had PD. Overall response rate (ORR; CR + PR) was 28.6%. Duration of response exceeded 8 months in 5 of the 6 responders. Disease control rate (ORR + SD) was 57.1%. Disease control has been maintained for 7 pts after a planned treatment completion at 48 weeks. Of the 17 pts who had tissue available for PD-L1 expression evaluation, 11 (64.7%) had a tumor proportion score (TPS) of < 1%, and 3 (17.6) had a TPS of > 50%. Conclusions: Cemiplimab showed an acceptable safety profile and demonstrated antitumor activity in pretreated pts with NSCLC. Pivotal trials of cemiplimab as monotherapy or in combination with other treatments in pts with advanced NSCLC are currently enrolling (NCT03088540; NCT03409614). Clinical trial information: NCT02383212.
Databáze: OpenAIRE
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