Efficacy and safety of necitumumab and pembrolizumab combination therapy in advanced non-small-cell lung cancer with ≥50% PD-L1 expression: A nonrandomized phase II trial.
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Horiike Atsushi, Wakui Hiroshi, Sugawara Shunichi, Minegishi Yuji, Tasaka Sadatomo, Kusumoto Sojiro, Sakatani Toshio, Suzuki Hiroyuki, Hosomi Yukio, Tambo Yuichi, Shimokawa Tsuneo, Ishida Hiroo, Miyauchi Eisaku, Naoki Katsuhiko, Fukuhara Tatsuro, Mura Emiko, Tsurui Toshiaki, Suzuki Risako, Iriguchi Nana, Ishiguro Tomoyuki, Hirasawa Yuya, Manabe Ryo, Shimokawa Masahiro, Ohkuma Ryotaro, Ariizumi Hirotsugu, Kubota Yutaro, Hamada Kazuyuki, Takenoshita Sachiko, Ryu Kakei, Sambe Takehiko, Inoue Eisuke, Wada Satoshi, Yoshimura Kiyoshi, Sagara Hironori, Kobayashi Shinichi, Tsunoda Takuya
Аннотация
PATIENTS AND METHODS: This nonrandomized, multicenter, open-label, single-arm phase II trial included patients with previously untreated advanced NSCLC who had a PD-L1 tumor proportion score of ≥50%. Patients received pembrolizumab and necitumumab every 3 weeks for up to 35 cycles. The primary endpoint was the investigator-assessed objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.
RESULTS: The sample comprised 50 patients (38 men, 12 women; median age: 72 years, range: 51-90 years). The ORR was 76.0% (95% confidence intervals: 61.9-86.9; P < 0.0001), with complete and partial response rates of 2.0% and 74.0%, respectively. Moreover, 10.0% and 8.0% of the patients had stable and progressive disease, respectively, whereas 6.0% could not be evaluated. The median PFS was 15.7 months, whereas the median OS was not reached at the time of analysis. The most common treatment-related adverse events were rash (64.0%) and hypomagnesemia (60.0%). Grade 3 interstitial lung disease occurred in five patients (10.0%), and grade 5 cardiac arrest occurred in one patient (2.0%).
CONCLUSIONS: The pembrolizumab and necitumumab combination exhibited a promising ORR of 76.0% with a manageable safety profile in patients with NSCLC who had high PD-L1 expression. These findings highlight the need for further research on this regimen for patients with advanced NSCLC who have high PD-L1 expression.