Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Mini Oral session: Melanoma and other skin tumours

LBA42 - Combined nivolumab and ipilimumab with or without stereotactic body radiation therapy for advanced Merkel cell carcinoma

Date

12 Sep 2022

Session

Mini Oral session: Melanoma and other skin tumours

Topics

Immunotherapy;  Radiation Oncology

Tumour Site

Non-Melanoma Skin Cancers

Presenters

Sungjune Kim

Citation

Annals of Oncology (2022) 33 (suppl_7): S808-S869. 10.1016/annonc/annonc1089

Authors

S. Kim1, E. Wuthrick2, D.M. Blakaj3, Z. Eroglu4, C. Verschraegen5, R. Thapa6, M. Mills2, K. Dibs3, C. LIveringhouse2, J. Russell7, J. Caudell8, A. Tarhini9, J. Markowitz4, D. Chen6, T. Rose10, J. Messina11, V. Sondak4, K. Tsai11, N.I. Khushalani4, A. Brohl4

Author affiliations

  • 1 Radiation Oncology & Immunology, H. Lee Moffitt Cancer Center University of South Florida, 33612 - Tampa/US
  • 2 Radiation Oncology, H. Lee Moffitt Cancer Center & Research Institute - Magnolia Campus, 33612 - Tampa/US
  • 3 Radiation Oncology, OSUCCC - The Ohio State University Comprehensive Cancer Center - James, 43210 - Columbus/US
  • 4 Cutaneous Oncology, H. Lee Moffitt Cancer Center & Research Institute - Magnolia Campus, 33612 - Tampa/US
  • 5 Medical Oncology Dept., OSUCCC - The Ohio State University Comprehensive Cancer Center - James, 43210 - Columbus/US
  • 6 Biostatistics, H. Lee Moffitt Cancer Center & Research Institute - Magnolia Campus, 33612 - Tampa/US
  • 7 Head And Neck/cutaneous, University of Utah Health - Cancer Hospital, 84112 - Salt Lake City/US
  • 8 Radiation Oncology, H. Lee Moffitt Cancer Center University of South Florida, 33612 - Tampa/US
  • 9 Cutaneous Oncology And Immunology Department, H. Lee Moffitt Cancer Center & Research Institute - Magnolia Campus, 33612 - Tampa/US
  • 10 Radiology, H. Lee Moffitt Cancer Center & Research Institute - Magnolia Campus, 33612 - Tampa/US
  • 11 Pathology, H. Lee Moffitt Cancer Center & Research Institute - Magnolia Campus, 33612 - Tampa/US
More

Resources

Login to access the resources on OncologyPRO.

Abstract LBA42

Background

Merkel Cell Carcinoma is an aggressive cutaneous malignancy associated with Merkel cell polyomavirus or UV exposure. In recent years, anti-PD1/PDL1 therapy has dramatically improved the treatment landscape, but outcome remains poor among patients who progress on this therapy.

Methods

In this multicenter phase 2 randomized study, patients with unresectable, recurrent or metastatic Merkel cell carcinoma patients received NIVO 240mg IV q2 wks plus IPI 1mg/kg IV q6 wks (Arm A) or NIVO 240mg IV q2 wks plus IPI 1mg/kg IV q6 wks plus stereotactic body radiation therapy (SBRT) to 24Gy in 3 fractions at week 2 (Arm B). Patients were required to have at least two measurable sites of disease to ensure that at least one non-irradiated site could be followed for treatment response. Both arms were experimental and randomized in a 1:1 ratio based on a Bayesian pick-the-winner design with each arm using a Simon’s Mini-Max two-stage design. Patients were stratified by prior treatment with immune checkpoint inhibitor (ICI). The primary endpoint was objective response rate (ORR). Tumor status was assessed every 12 weeks and evaluated by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).

Results

50 patients (24 ICI-naïve, 26 with prior ICI) received ≥1 dose of NIVO plus IPI and 24 received SBRT (median follow-up 14.6 months). ORR in ICI-naïve patients was 100% [95%CI, 82%-100%], 41% with complete response. ORR in prior ICI patients was 31% [95%CI, 15%-52%], 15% with complete response. No significant differences in ORR were observed between Arms A and B (72% vs. 52%, p=0.26). Median duration of response was not reached [95%CI, 33.9 months-NE] in the ICI-naïve cohort and was 10.8 months [95% CI, 4.9 months-NE] in the prior ICI cohort. Treatment was well tolerated with a toxicity profile similar to that previously observed.

Conclusions

In this study, first-line therapy with NIVO plus IPI in patients with advanced MCC demonstrated an exceptionally high ORR of 100%, with durable responses and a manageable safety profile. NIVO plus IPI also exhibited clinical activity in patients who progressed on prior anti-PD1/PDL1 monotherapy. Addition of SBRT did not alter the efficacy of NIVO plus IPI in this study.

Clinical trial identification

NCT03071406.

Editorial acknowledgement

Legal entity responsible for the study

H. Lee. Moffitt Cancer Center.

Funding

Bristol Myers Squibb.

Disclosure

S. Kim: Other, Institutional, Research Grant: Bristol Myers Squibb, AstraZeneca. E. Wuthrick: Other, Institutional, Advisory Role: Viewray, Varian, AlphaTau, Castle Biosciences, Teiko. J. Caudell: Other, Institutional, Funding: Varian, Galera. A. Tarhini: Financial Interests, Personal, Advisory Board: Bristol Myers Squib, Genentech/Roche, Easai, Instil Bio, Clinigen, Regeneron, Sanofi-Genzyme, Novartis, Partner Therapeutics, BioNTech, Merck; Financial Interests, Personal and Institutional, Invited Speaker: Bristol Myers Squib; Financial Interests, Institutional, Invited Speaker: Genentech-Roche, Nektar, Checkmate, InflaRx; Financial Interests, Institutional, Research Grant: Regeneron, Sanofi-Genzyme, Clinigen, Acrotech, Pfizer, OncoSec. J. Markowitz: Other, Institutional, Funding: Merck, Microba, Jackson Laboratory, Morphogenesis. V. Sondak: Other, Institutional, Advisory Board: Bristol-Myers-Squibb, Eisai, Iovance, Merck, Novartis, Regeneron, Statking; Other, Institutional, Funding: Neogene, Turnstone. N.I. Khushalani: Financial Interests, Personal, Advisory Board: Bristol Myers-Squibb, Regeneron Pharmaceuticals, Merck, Iovance Biotherapeutics, Genzyme, Nektar, Castle Biosciences, Instil Bio, Novartis; Financial Interests, Personal, Other, Data Safety Monitoring Committee: Incyte, Astra-Zeneca; Financial Interests, Personal, Stocks/Shares: Amarin, Asensus Surgical, Bellicum; Financial Interests, Institutional, Invited Speaker: Bristol Myers-Squibb, Merck, Novartis, GlaxoSmithKline, HUYA, Regeneron, Celgene, Replimmune; Financial Interests, Personal, Invited Speaker: Bristol Myers-Squibb, Regeneron, Nektar; Financial Interests, Invited Speaker: Replimmune; Non-Financial Interests, Principal Investigator, Global clinical trial: Huya. A. Brohl: Other, Institutional, Advisory Board: Deciphera, Bayer. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.