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

PURPOSE: This study investigated the efficacy and safety of pembrolizumab and necitumumab as first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC) who had ≥50% programmed death-ligand 1 (PD-L1) expression. 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.

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Journal
Clinical Cancer Research
Published
2026-07-27
DOI
https://doi.org/10.1158/1078-0432.ccr-25-2751
Primary Topic
Cancer Immunotherapy and Biomarkers
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article
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article

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

Takuya Tsunoda, Takehiko Sambe, Toshiaki Tsurui, Yutaro Kubota et al.
Clinical Cancer Research
Cancer Immunotherapy and Biomarkers
article

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

Takuya Tsunoda, Takehiko Sambe, Toshiaki Tsurui, Yutaro Kubota, Kiyoshi Yoshimura, Yuichi Tambo, Kakei Ryu, Eisuke Inoue, Eisaku Miyauchi, Tsuneo Shimokawa, Hiroshi Wakui, Hiroo Ishida, Atsushi Horiike, Sadatomo Tasaka, Hirotsugu Ariizumi, Ryotaro Ohkuma, Toshio Sakatani, Yukio Hosomi, Tomoyuki Ishiguro, Kazuyuki Hamada, Masahiro Shimokawa, Sachiko Takenoshita, Tatsuro Fukuhara, Satoshi Wada, Nana Iriguchi, Shunichi Sugawara, Yuya Hirasawa, Hironori Sagara, Hiroyuki Suzuki, Katsuhiko Naoki, Yuji Minegishi, Emiko Mura, Risako Suzuki, Ryo Manabe, Sojiro Kusumoto, Shinichi Kobayashi
article en

Abstract

PURPOSE: This study investigated the efficacy and safety of pembrolizumab and necitumumab as first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC) who had ≥50% programmed death-ligand 1 (PD-L1) expression. 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.

Clinical Cancer Research
Jikei University School of Medicine (JP), SHOWA Medical University (JP), Fukushima Medical University (JP), Hirosaki University (JP), Showa Corporation (JP), NTT Medical Center (JP), Tokyo Metropolitan Komagome Hospital (JP), Tohoku University Hospital (JP), Kanazawa University Hospital (JP), Miyagi Prefectural Hospital Organization (JP), Kitasato University Hospital (JP), Mitsui Memorial Hospital (JP), Yokohama Municipal Citizen's Hospital (JP), Fukushima Medical University Hospital (JP), SHOWA Medical University Hospital (JP), Sendai Kousei Hospital (JP), Kitasato University (JP)
Good health and well-being
Openalex Percentile: Top 12%
Cancer Immunotherapy and Biomarkers
DOISourceOpenAlex
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