Journal Article

Pembrolizumab plus chemotherapy in Japanese patients with metastatic squamous non‐small‐cell lung cancer in KEYNOTE‐407

Yamamoto, Nobuyuki, Kishi, Kazuma, Schwarzenberger, Paul, Imamura, Fumio, Sugawara, Shunichi, Udagawa, Hibiki, Katakami, Nobuyuki, Tokito, Takaaki, Okada, Morihito, Tanaka, Kentaro, Hosomi, Yukio, Ohashi, Kadoaki, Okishio, Kyoichi, Nishio, Makoto, Kurata, Takayasu, Adachi, Noriaki, Fukuhara, Tatsuro, Tanaka, Hiroshi, Horinouchi, Hidehito, Saka, Hideo, Aoe, Keisuke, Satouchi, Miyako, Kato, Terufumi, Hirashima, Tomonori, Nakahara, Yasuharu, Noguchi, Kazuo, Yokoyama, Takuma, Kasahara, Kazuo

2023

Overview

The global phase III KEYNOTE‐407 (NCT02775435) trial showed that pembrolizumab plus chemotherapy prolonged overall and progression‐free survival (OS/PFS) versus placebo plus chemotherapy in patients with metastatic squamous non‐small‐cell lung cancer (NSCLC). We present outcomes of patients from Japan enrolled in KEYNOTE‐407. Patients were randomized 1:1 to receive pembrolizumab 200 mg or placebo with paclitaxel 200 mg/m2 every 3 weeks (Q3W) or nab‐paclitaxel 100 mg/m2 (weekly) plus carboplatin area under the concentration‐time curve of 6 mg/mL/min Q3W for four cycles, followed by pembrolizumab or placebo Q3W for a total of 35 cycles. Primary end‐points were OS and PFS per RECIST version 1.1 by blinded independent central review. Fifty patients were randomized at Japanese sites (pembrolizumab plus chemotherapy, n = 22; placebo plus chemotherapy, n = 28). Median follow‐up time at data cut‐off (May 9, 2019) was 15.1 (range, 0.5–24.0) months. Median OS (95% confidence interval [CI]) was 17.3 (12.5–not reached) versus 11.0 (8.6–19.5) months in the pembrolizumab plus chemotherapy versus placebo plus chemotherapy group (hazard ratio [HR] 0.56; 95% CI, 0.27–1.15). Median PFS (95% CI) was 8.3 (6.1–13.0) versus 7.2 (3.9–8.8) months (HR 0.65; 95% CI, 0.35–1.23). Grade 3–5 adverse events (AEs) occurred in 86% and 75% of patients, respectively. There were three fatal AEs, two of which were treatment‐related (one from each treatment group, pneumonitis and pulmonary hemorrhage). Efficacy and safety outcomes were consistent with the global study and support the use of pembrolizumab plus chemotherapy in Japanese patients with metastatic squamous NSCLC. Pembrolizumab plus platinum‐based chemotherapy prolonged overall survival and progression‐free survival, and provided durable clinical benefit with manageable safety versus placebo plus chemotherapy in Japanese patients with metastatic squamous non‐small‐cell lung cancer (NSCLC) in the phase III KEYNOTE‐407 study. These data support the continued use of pembrolizumab plus platinum‐based chemotherapy as first‐line treatment for metastatic squamous NSCLC in Japanese patients.

• Publisher: John Wiley & Sons, Inc,John Wiley and Sons Inc
• Subject: Antineoplastic Combined Chemotherapy Protocols - adverse effects / Cancer therapies / Carboplatin / carcinoma / Carcinoma, Non-Small-Cell Lung - pathology / Carcinoma, Squamous Cell - drug therapy / Carcinoma, Squamous Cell - etiology / Chemotherapy / clinical trial / East Asian People / Hemorrhage / Humans / immune checkpoint inhibitor / immunotherapy / Japan / Ligands / Lung cancer / Lung diseases / Lung Neoplasms - pathology / Metastases / Metastasis / Non-small cell lung carcinoma / non‐small‐cell lung cancer / Original / ORIGINAL ARTICLES / Paclitaxel / Patients / Pembrolizumab / Placebos / Pneumonitis / Radiation therapy / Small cell lung carcinoma