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Poster display session

2603 - Avelumab treatment in chemotherapy-naïve patients with distant metastatic Merkel cell carcinoma (mMCC)

Date

10 Sep 2017

Session

Poster display session

Topics

Cancers in Adolescents and Young Adults (AYA);  Immunotherapy;  Skin Cancers

Presenters

Sandra D'Angelo

Citation

Annals of Oncology (2017) 28 (suppl_5): v428-v448. 10.1093/annonc/mdx377

Authors

S.P. D'Angelo1, J. Russell2, J. Hassel3, C. Lebbé4, B. Chmielowski5, G. Rabinowits6, P. Terheyden7, I. Brownell8, I. Zwiener9, M. Bajars10, M. Hennessy11, H.L. Kaufman12

Author affiliations

  • 1 Medical Oncology, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
  • 2 Medical Oncology, H. Lee Moffitt Cancer Center and Research Institute, Inc, Tampa/US
  • 3 Department Of Dermatology And Nct, Universitaetsklinikum Heidelberg, 69120 - Heidelberg/DE
  • 4 Aphp Dermatology And Cic Departments, Hôpital Saint-Louis, INSERM U976, Université Paris Diderot, Paris/FR
  • 5 Department Of Medicine, Hematology/oncology, University of California Los Angeles, Jonsson Comprehensive Cancer Center, 90095 - Los Angeles/US
  • 6 Head And Neck Cancer, Dana Farber Cancer Institute, 02215 - Boston/US
  • 7 Department Of Dermatology, University of Lübeck, 23538 - Lübeck/DE
  • 8 Dermatology, National Cancer Institute, 20892-1908 - Bethesda/US
  • 9 Biostatistics, Merck KGaA, 64293 - Darmstadt/DE
  • 10 Immunooncology, Global Clinical Development, Merck Serono SIA, LV1005 - Riga/LV
  • 11 Global Clinical Development, Immuno-oncology, EMD Serono Research Center, 1821 - Billerica/US
  • 12 Surgical Oncology, Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey, 08901 - New Brunswick/US
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Resources

Abstract 2603

Background

MCC is a rare, aggressive skin cancer. In a phase 2 study of patients with mMCC progressed on or after chemotherapy (JAVELIN Merkel 200; NCT02155647), avelumab (a human anti–PD-L1 antibody) showed durable responses and a manageable safety profile, including an objective response rate (ORR) of 33.0%, proportion of responses with ≥1-year duration of 74% (Kaplan-Meier estimate), and estimated 1-year overall survival (OS) rate of 52%. Based on these results, avelumab was approved by the US FDA in March 2017 and is the only approved treatment for patients with mMCC. Here, we report early interim results from patients with mMCC receiving first-line avelumab.

Methods

Eligible patients with mMCC and no prior systemic treatment for metastatic disease received avelumab 10 mg/kg Q2W. Tumors were assessed every 6 weeks (RECIST v1.1) by independent review committee (IRC). Adverse events (AEs) were assessed by NCI CTCAE v4.0.

Results

At data cutoff on Dec 30, 2016, 29 of 112 planned patients had been enrolled. Median follow-up was 3.1 months (range 0.3–8.5) and median duration of treatment was 8.1 weeks (range 2.0–37.9). Of 16 patients with ≥13 weeks of follow-up, confirmed ORR by IRC was 62.5% (95% CI 35.4–84.8) with response ongoing in all 10 patients, including in all 5 patients with ≥6 months of follow-up. Of 25 patients with ≥6 weeks of follow-up, unconfirmed ORR by IRC was 68.0% (95% CI 46.5–85.1); responses were ongoing at last follow-up in 16 of 17 responders (94.1%; 1 censored due to other therapy). 23 of 29 patients (79.3%) had a treatment-related AE (TRAE), including 5 (17.2%) with a grade 3 or 4 TRAE. There was 1 immune-mediated TRAE (grade 1 rash). 5 patients (17.2%) discontinued avelumab due to a TRAE. There were no treatment-related deaths. Updated analyses of 39 patients will be presented (n = 29 and n = 14 with ≥13 weeks and ≥6 months of follow-up, respectively; data cutoff Mar 24, 2017), including PFS and OS analyses.

Conclusions

First-line avelumab treatment resulted in early responses and a high ORR in distant mMCC, substantiating prior findings with second-line or later avelumab treatment. Most responses were ongoing, including all responders with ≥6 months of follow-up. Enrollment is ongoing.

Clinical trial identification

NCT02155647 EMR100070-003

Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany; Pfizer Inc, New York, NY, USA.

Funding

Merck KGaA, Darmstadt, Germany; Pfizer Inc, New York, NY, USA.

Disclosure

S.P. D\'Angelo: Provided a consultant/independent contractor role for EMD Serono, Pfizer and Nektar. J. Russell: Provided consulting/independent contractor role to EMD Serono. J. Hassel: Received research funding from Bristol-Myers Squib, provided an advisory role to Amgen and MSD, and received honoraria from Bristol-Myers Squibb, MSD, Roche and Novartis. C. Lebbé: Advisory/consulting role for Roche, Bristol-Myers Squib, Novartis, Amgen, MSD, GSK. Research funding from Roche and Bristol-Myers Squibb. Speaker\'s Bureau\'s for Bristol-Myers Squib, Amgen, Roche, Novartis. Honoraria from Roche, Bristol-Myers Squibb, Novartis, Amgen. Travel accommodation from Roche. Bristol-Myers Squibb, Novartis. B. Chmielowski: Provided an advisory role for EMD Serono, Merck, Bristol-Myers Squibb, Genentech, Immunocore and Eisai. Also served as a consultant/independent contractor for Amgen and has participated in speaker\'s bureau\'s for Janssen and Genentech. G. Rabinowits: Institution has received research funding from EMD Serono, Exelixis and Millennium. GR has provided a consulting/advisory role and has received honoraria from EMD Serono. P. Terheyden: Provided an advisory role for Bristol-Myers Squibb, Merck, Novartis and Roche. Has also received honoraria from Bristol-Myers Squibb, Novartis and Roche. I. Zwiener: Employee of Merck KGaA, Darmstadt, Germany. M. Bajars: Employee of Merck Serono SIA. M. Hennessy: Employee of EMD Serono Inc, Billerica MA, USA. H.L. Kaufman: Consultancy for and honoraria from Amgen, Celldex, Compass Therapeutics, EMD Serono, Turnstone Biologics, Prometheus, Sanofi, Merck KGaA,. Research funding from Amgen, EMD Serono, Viralytics, Prometheus, Merck KGaA. Speakers bureau for Merck KGaA. All other authors have declared no conflicts of interest.

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