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. 2023 Jan 2;4(2):100461.
doi: 10.1016/j.jtocrr.2022.100461. eCollection 2023 Feb.

Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC

Zoran Andric  1 , Gabriella Gálffy  2 , Manuel Cobo Dols  3 , Barna Szima  4 , Goran Stojanovic  5 , Marina Petrovic  6 , Enriqueta Felip  7 , David Vicente Baz  8 , Santiago Ponce Aix  9 , Oscar Juan-Vidal  10 , Zsuzsanna Szalai  11 , Gyorgy Losonczy  12 , Antonio Calles Blanco  13 , Reyes Bernabe  14 , Gema García Ledo  15 , Andrés Aguilar Hernández  16 , Klaus Duecker  17 , Dongli Zhou  18 , Andreas Schroeder  17 , Guelseren Guezel  17 , Fortunato Ciardiello  19
Affiliations

Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC

Zoran Andric et al. JTO Clin Res Rep. .

Abstract

Introduction: We present the results of a phase 2a trial of first-line avelumab (anti-programmed death-ligand 1 antibody) plus cetuximab (anti-EGFR antibody) in patients with advanced squamous NSCLC.

Methods: Patients with recurrent or metastatic squamous NSCLC received avelumab 800 mg (d 1 and 8), cetuximab 250 mg/m2 (d 1) and 500 mg/m2 (d 8), cisplatin 75 mg/m2 (d 1), and gemcitabine 1250 mg/m2 (d 1 and 8) for four 3-week cycles, followed by avelumab 800 mg and cetuximab 500 mg/m2 every 2 weeks. The primary end point was the best overall response; the secondary end points were progression-free survival, duration of response, overall survival, and safety. Efficacy analyses were reported from an updated data cutoff.

Results: A total of 43 patients were enrolled. The median follow-up was 6.6 months for the primary analyses and 9.2 months for the efficacy analyses. In the efficacy analyses, 15 patients had a confirmed partial response (objective response rate, 34.9% [95% confidence interval: 21.0%-50.9%]), and the median duration of response was 7.1 months (95% confidence interval: 4.2-12.5 mo). The median progression-free survival and overall survival were 6.1 months and 10.0 months, respectively. In the safety analyses (primary analysis), 38 patients (88.4%) had a treatment-related adverse event, of whom 24 (55.8%) had a grade 3 or higher treatment-related adverse event.

Conclusions: The combination of avelumab + cetuximab and chemotherapy showed antitumor activity and tolerable safety; however, the ORR was not improved compared with those reported for current standards of care (NCT03717155).

Keywords: Avelumab; Cetuximab; EGFR; Non–small cell lung cancer; PD-L1.

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Figures

Figure 1
Figure 1
Best change in the sum of target lesions from baseline in assessable patients (data cutoff, November 4, 2020; N = 39).
Figure 2
Figure 2
(A) Time to PFS per patient and (B) Kaplan-Meier analysis of PFS (data cutoff, November 4, 2020; N = 43). CI, confidence interval; PFS, progression-free survival.
Figure 3
Figure 3
Kaplan-Meier analysis of OS (data cutoff, November 4, 2020; N = 43). CI, confidence interval; OS, overall survival.
See this image and copyright information in PMC

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