Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Warsaw, Poland
Piotr Rutkowski, Enriqueta Felip, Victor Moreno, Jose Manuel Trigo Perez, Aitana Calvo, Dariusz Kowalski, Diego Cortinovis, James J. Lee, George Manikhas, Elizabeth Ruth Plummer, Michele Maio, Paolo Antonio Ascierto, Vladimir Ivanovich Vladimirov, Dana Gaffney, Lilian Y. Li, Kyounghwa Bae, James G. Greger, Chu Ri Shin, Hong Xie, Emiliano Calvo
Background: Cetrelimab (JNJ-63723283) is an IgG4, anti-programmed cell death protein-1 (PD-1) antibody. Here we present updated results from an ongoing phase 1/2 study of cetrelimab in patients (pts) with advanced or refractory solid cancers. Methods: Part 2 of the study evaluated safety and efficacy of cetrelimab at 240 mg Q2W, a recommended phase 2 dose selected in Part 1 (Calvo JCO 2018; 36 suppl 5:58). Tumor types for Part 2 included non-small cell lung cancer (NSCLC), melanoma (MEL), bladder, renal cell, small cell lung cancer (SCLC), microsatellite-high (MSI-H)/DNA mismatch repair deficient (dMMR; locally or centrally tested) colorectal cancer (CRC) and gastric/esophageal cancer (GCA/EC). Tumor response was assessed by the investigator following RECIST v1.1. Results: As of 3 Sep 2018, 192 pts have been treated with cetrelimab from 80–800 mg Q2W and 480 mg Q4W. Median age was 60 years (23–86), and median prior regimens was 2 (1–12). Median duration of treatment was 85 days (1–561); 82 pts remain on treatment. Full receptor occupancy was maintained throughout dosing interval. Most common adverse events (AEs) were asthenia (19%), fatigue (19%), dyspnea (16%) and diarrhea (16%). Grade ≥3 AEs, regardless of causality, were reported in 45% of pts; most common were anemia (6%), dyspnea (4%), increased ALT (3%) and increased AST (3%). Observed serious AEs were dyspnea (4%), pleural effusion and intestinal obstruction (3% each). All grade and grade ≥3 immune-related AEs were reported in 30% and 7% of pts, respectively. Among response-evaluable pts (n = 156) from Parts 1 and 2, overall response rate (ORR) was 15%, with 2 complete and 22 partial responses. Half of pts had stable disease or better. ORR was 26% (7/27) in NSCLC (42% [5/12] in PD-L1+ NSCLC [≥50% by IHC]), 25% (12/49) in MEL (28% [12/43] in non-uveal MEL), 50% (1/2) in renal cancer, 8% (2/26) in MSI-H/dMMR CRC (recruited later per amendment) and 14% (2/14) in GCA/EC. No responses were observed in bladder cancer (n = 4) or SCLC (n = 10). Conclusions: The safety profile and preliminary activity of cetrelimab in immune-sensitive advanced cancers is consistent with known PD-1 inhibitors. The study is ongoing and analysis by PD-L1 status will be reported later. Clinical trial information: NCT02908906
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