18-month efficacy and safety update from JAVELIN Merkel 200 part A: A phase II study of avelumab in metastatic Merkel cell carcinoma progressed on chemotherapy.

Authors

null

Sandra P. D'Angelo

Memorial Sloan Kettering Cancer Center & Weill Cornell Medical College, New York, NY

Sandra P. D'Angelo, Jeffery Scott Russell, Shailender Bhatia, Omid Hamid, Janice M. Mehnert, Patrick Terheyden, Kent C. Shih, Isaac Brownell, Celeste Lebbé, Karl D. Lewis, Gerald P. Linette, Michele Milella, Meliessa Hennessy, Marcis Bajars, Isabella Zwiener, Paul Nghiem

Organizations

Memorial Sloan Kettering Cancer Center & Weill Cornell Medical College, New York, NY, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, FL, University of Washington Medical Center at South Lake Union, Seattle, WA, The Angeles Clinic and Research Institute, Los Angeles, CA, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, University of Lubeck, Lubeck, Germany, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, National Cancer Institute, Bethesda, MD, University Paris Diderot, Paris, France, University of Colorado Denver, School of Medicine, Aurora, CO, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, Istituto Nazionale Tumori Regina Elena, IRCCS, Rome, Italy, EMD Serono, Billerica, MA, Merck KGaA, Darmstadt, Germany

Research Funding

Pharmaceutical/Biotech Company

Background: Merkel cell carcinoma (MCC) is a rare, aggressive skin cancer. Avelumab, a human anti–PD-L1 monoclonal antibody, is FDA and EMA approved for the treatment of metastatic MCC (mMCC). Here, we report efficacy and safety data for avelumab in patients (pts) with mMCC at ≥18-mo of follow-up. Methods: Pts with mMCC and progression on prior chemotherapy received avelumab 10 mg/kg IV Q2W. Objective response rate (ORR), duration of response (DOR), and progression-free survival (PFS) were evaluated by independent review committee (RECIST v1.1) with tumor assessment every 6 wks; overall survival (OS) and adverse events (AEs; NCI CTCAE v4.0) were also evaluated. Results: As of Mar 24, 2017, 88 pts were treated and followed for a median of 23.0 mo (range 18.7–32.0). Median treatment duration was 17 wks (range 2–132; mean 35 wks ±37). Treatment was ongoing in 15 pts (17%); 7 pts (8%) voluntarily discontinued with continuing responses (5 complete responses [CR] and 2 partial responses). Other reasons for discontinuation were disease progression (n = 42; 48%), death (n = 10; 11%), AE (n = 8; 9%), or consent withdrawal/other (n = 6; 7%). Confirmed ORR of 33% (95% CI 23.3–43.8; CR in 11.4%) remained unchanged from previous analysis and median DOR has not been reached (range 2.8–24.9 mo; 95% CI 18.0–not estimable). Responses were ongoing in 20/29 pts (69%), including 5 pts with > 2 y of follow-up. PFS curve showed a plateau with identical 12- and 18-mo rates of 29% (95% CI 19–39). Median OS was 12.6 mo (95% CI 7.5-19.0) and the 12- and 18-mo OS rates were 51% (95% CI 40–61) and 40% (95% CI 29–50), respectively. 66 pts (75%) had a treatment-related (TR)AE, most commonly ( > 10%) fatigue (25%), infusion-related reaction (15%; all grade 1/2), nausea (11%), and diarrhea (11%); 8 (9%) had a grade ≥3 TRAE. 17 pts (19%) had an immune-related AE, which was grade ≥3 in 4 pts (4.5%). No treatment-related deaths occurred. Conclusions: Updated results demonstrate continued durable antitumor activity of avelumab in pts with mMCC, beyond that expected with cytotoxic chemotherapy. The median OS exceeding 1 y and manageable safety profile of avelumab signify a clinically meaningful benefit in pts with mMCC. Clinical trial information: NCT02155647

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2018 ASCO-SITC Clinical Immuno-Oncology Symposium

Session Type

Poster Session

Session Title

Poster Session A

Track

Developmental Therapeutics,Genitourinary Cancer,Head and Neck Cancer,Lung Cancer,Melanoma/Skin Cancers,Gastrointestinal Cancer,Breast and Gynecologic Cancers,Combination Studies,Implications for Patients and Society,Miscellaneous Cancers,Oncolytic Viruses,Hematologic Malignancies

Sub Track

Immune Checkpoints and Stimulatory Receptors

Clinical Trial Registration Number

NCT02155647

Citation

J Clin Oncol 36, 2018 (suppl 5S; abstr 192)

DOI

10.1200/JCO.2018.36.5_suppl.192

Abstract #

192

Poster Bd #

K1

Abstract Disclosures