Efficacy and Safety of Necitumumab plus Pembrolizumab in Patients Who Relapsed After Chemotherapy for Metastatic Nonsquamous NSCLC
This multicenter phase 1b study was designed to determine the efficacy and safety of necitumumab combined with pembrolizumab in patients with metastatic non–small-cell lung cancer (NSCLC).
In Part A of the study, escalating doses of necitumumab (600 mg and 800 mg IV) were administered on days 1 and 8 every 3 weeks (Q3W) together with pembrolizumab (200 mg IV) on day 1 Q3W. Because no dose-limiting toxicity was observed, patients in Part B (expansion cohort) received necitumumab 800 mg IV Q3W combined with pembrolizumab (200 mg IV Q3W).
Major eligibility criteria included progression after 1 or more platinum-based chemotherapy regimens and ECOG PS 0 to 1. Primary end points were tolerability and objective response rate (ORR). PD-L1 status was centrally assessed using PD-L1 IHC 22C3 pharmDx assay.
The interim analysis population included 34 nonsquamous patients. After median follow-up of 6.0 months, 10 (29%) patients had partial response, both confirmed and unconfirmed, to the combination of necitumumab and pembrolizumab. Among patients who were PD-L1 negative, the ORR was 18%. Among patients who were PD-L1 positive weak and strong, the ORR was 60% and 40%, respectively. The disease control rate was 68%.
At 6 months, 55% of patients receiving the combination of necitumumab and pembrolizumab were progression-free (95% confidence interval [CI], 36%-71%). Median progression-free survival was 6.9 months (95% CI, 2.7 months to not reached).
The most common grade 3 and higher adverse events (AEs) associated with the combination of necitumumab and pembrolizumab were skin rash (9%), hypomagnesemia (9%), and venous thromboembolism (9%). One patient died due to respiratory tract infection. Five (15%) patients discontinued the combination of necitumumab and pembrolizumab because of an AE.
Researchers concluded that the combination of necitumumab and pembrolizumab was effective and safe in patients with metastatic NSCLC who progressed after 1 or more platinum-based chemotherapy regimens.
Besse, et al. WCLC 2016. Abstract MA 09.11. ID 4712.