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EACH: A phase II study evaluating the safety and anti-tumour activity of avelumab and cetuximab in recurrent/metastatic squamous cell carcinomas
Forster, M. Metcalf, Robert Sacco, J. Kong, A. Wheeler, G. Forsyth, S. Bhat, R. Blair, K. Ward, J Lowe, H.
Forster, M.
Metcalf, Robert
Sacco, J.
Kong, A.
Wheeler, G.
Forsyth, S.
Bhat, R.
Blair, K.
Ward, J
Lowe, H.
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Abstract
Background: Patients with R/M SCC have low response rates to second line therapies,
including PD-1 inhibitors nivolumab and pembrolizumab, representing an area of
unmet clinical need. Cetuximab has modest activity as a single agent but potentiates
the activity of radiotherapy in locally advanced head & neck SCC (HNSCC) and
chemotherapy in R/M HNSCC. Cetuximab initiates Natural Killer cell antibodydependent
cell-mediated cytotoxicity, resulting in an anti-tumour immune response
and the potential to augment the activity of PD-1/PD-L1 inhibition.Methods: Trial entry required histologically confirmed R/M SCC of any site, unselected
by PD-L1 expression, considered incurable by local therapies and no previous
treatment with cetuximab for recurrent/metastatic disease. Prior therapy with anti-
PD-1, anti-PD-L1 or anti-PD-L2 was excluded. Patients had avelumab 10 mg/kg +
cetuximab 500 mg/m2 intravenously every 2 weeks, for up to 1 year. Primary
endpoint was occurrence of dose-limiting toxicity within 42 days of treatment
starting, graded using CTCAE v5. Secondary endpoints were objective response (ORR)
and disease control rate (DCR) at 6 and 12 months using iRECIST.
Results: 16 patients, median age 58 years (range 34 e 88), were enrolled from 2 UK
hospitals between July 2018 and October 2019. The trial stopped after completing the
safety run-in. 5 patients remain on treatment, 9 stopped treatment early (7 disease
progression, 1 patient choice, 1 due to risk of COVID-19). 2 patients died whilst on
treatment (both unrelated to trial treatment). Grade 3 AEs were seen in 4 patients
and grade 5 in 1 patient. None were related to trial treatment. No patients experienced
dose-limiting toxicity. Of 10 patients evaluable for response by iRECIST 2 (20%)
had complete response, 3 (30%) had partial response and 4 (40%) had stable disease
as their best response, representing an ORR of 50%. One patient had confirmed
disease progression. In 6 patients who remained on trial for >6 months, all 6 had
disease control at 6 months (2 CR, 1 PR, 3 SD).
Conclusions: Avelumab + cetuximab is safe and tolerable, and demonstrates promising
efficacy in R/M SCC patients.
Description
Date
2020
Publisher
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Keywords
Type
Meetings and Proceedings
Citation
Forster M, Metcalf R, Sacco J, Kong A, Wheeler G, Forsyth S, et al. 922P EACH: A phase II study evaluating the safety and anti-tumour activity of avelumab and cetuximab in recurrent/metastatic squamous cell carcinomas. Annals of Oncology. 2020;31:S665-S.