Dataset Information

A phase II open-label trial of avelumab plus axitinib in previously treated non-small-cell lung cancer or treatment-naive, cisplatin-ineligible urothelial cancer.

ABSTRACT:

Background

We hypothesized that avelumab plus axitinib could improve clinical outcomes in patients with advanced non-small-cell lung cancer (NSCLC) or urothelial carcinoma (UC).

Patients and methods

We enrolled previously treated patients with advanced or metastatic NSCLC, or untreated, cisplatin-ineligible patients with advanced or metastatic UC. Patients received avelumab 800 mg every 2 weeks (Q2W) and axitinib 5 mg orally two times daily. The primary endpoint was objective response rate (ORR). Immunohistochemistry was used to assess programmed death-ligand 1 (PD-L1) expression (SP263 assay) and the presence of CD8+ T cells (clone C8/144B). Tumor mutational burden (TMB) was assessed by whole-exome sequencing.

Results

A total of 61 patients were enrolled and treated (NSCLC, n = 41; UC, n = 20); 5 remained on treatment at data cut-off (26 February 2021). The confirmed ORR was 31.7% in the NSCLC cohort and 10.0% in the UC cohort (all partial responses). Antitumor activity was observed irrespective of PD-L1 expression. In exploratory subgroups, ORRs were higher in patients with higher (≥median) CD8+ T cells in the tumor. ORRs were higher in patients with lower TMB (ConclusionsIn previously treated patients with advanced/metastatic NSCLC, ORR appeared to be superior to anti-PD-L1 or anti-programmed cell death protein 1 monotherapy, irrespective of PD-L1 status, whereas in untreated, cisplatin-ineligible patients with advanced/metastatic UC, ORR was lower than expected, potentially limited by small patient numbers.

Trial registration

Clinicaltrial.gov NCT03472560; https://clinicaltrials.gov/ct2/show/NCT03472560.

SUBMITTER: Galffy G

PROVIDER: S-EPMC10265612 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

A phase II open-label trial of avelumab plus axitinib in previously treated non-small-cell lung cancer or treatment-naïve, cisplatin-ineligible urothelial cancer.

Galffy G G Lugowska I I Poddubskaya E V EV Cho B C BC Ahn M-J MJ Han J-Y JY Su W-C WC Hauke R J RJ Dyar S H SH Lee D H DH Serwatowski P P Estelles D L DL Holden V R VR Kim Y J YJ Vladimirov V V Horvath Z Z Ghose A A Goldman A A di Pietro A A Wang J J Murphy D A DA Alhadab A A Laskov M M

ESMO open 20230502 3

<h4>Background</h4>We hypothesized that avelumab plus axitinib could improve clinical outcomes in patients with advanced non-small-cell lung cancer (NSCLC) or urothelial carcinoma (UC).<h4>Patients and methods</h4>We enrolled previously treated patients with advanced or metastatic NSCLC, or untreated, cisplatin-ineligible patients with advanced or metastatic UC. Patients received avelumab 800 mg every 2 weeks (Q2W) and axitinib 5 mg orally two times daily. The primary endpoint was objective resp ...[more]

PMID: 37141847

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