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FIRST AND ONLY

BAVENCIO® (avelumab) is the first and only FDA-approved anti-PD-L1 immunotherapy for metastatic Merkel cell carcinoma (mMCC)1 

BAVENCIO has been prescribed for more than 1,000 US mMCC patients2*

*Estimate is based on IQVIA US sales and prescription data from April 2017 to June 2018.

JAVELIN Merkel 200 is the largest trial of immunotherapy in metastatic MCC with the longest patient follow-up to date3-5

A Phase 2, open-label, single-arm, multicenter trial

According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as measured by blinded independent central review committee. 

Assessed by independent central review committee.

  • BAVENCIO was administered at 10 mg/kg IV infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity
  • Patients were premedicated with antihistamine and acetaminophen prior to each infusion
  • Patients with radiological disease progression not associated with significant clinical deterioration§ could continue treatment
  • Tumor response assessments were performed every 6 weeks
  • The efficacy analysis was conducted when the last patient enrolled had completed 12 months of follow-up

§Absence of significant clinical deterioration was defined as no new or worsening symptoms, no change in performance status for  ≥ 2 weeks, and no need for salvage therapy.

Patient characteristics in the 2nd-line+ cohort

  • Median age of 73 years
  • Progression after receiving one or more lines of chemotherapy for distant mMCC
    • 35% of patients had 2 or more lines of previous therapy
    • 65% of patients had 1 line of previous therapy
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
  • The JAVELIN Merkel 200 trial included patients regardless of PD-L1 tumor expression or presence of Merkel cell polyomavirus (MCPyV)
  • Exclusion criteria included autoimmune disease; medical conditions requiring systemic immunosuppression; prior organ or allogenic stem cell transplantation; prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies; central nervous system (CNS) metastases; infection with HIV, hepatitis B, or hepatitis C; or ECOG performance score ≥ 2

In a Phase 2, open-label, single-arm, multicenter study of 88 patients with mMCC whose disease progressed on or after chemotherapy for distant metastatic disease

One-third of patients had an overall response

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Complete responses were also observed

  • 11% (n=10/88) complete response (95% CI, 6.6-19.9)3
  • 22% (n=19/88) partial response (95% CI, 13.5-31.7)3

||Response criteria were defined according to RECIST v1.1.

CI, confidence interval.

Responses were observed regardless of PD-L1 tumor expression or presence of Merkel cell polyomavirus (MCPyV)

35% (n=31/88) of study patients had received 2 or more lines of previous therapy

Durable responses extended beyond 1 year

Among patients with confirmed response (n=29)

86% (n=25/29) of responses lasted for atleast 6 months (range: 2.8 to 23.3+ months)

45% (n=13/29) of responses lasted for atleast 1 year (range: 2.8 to 23.3+ months)

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The median duration of response had not yet been reached at the time of analysis, with a minimum follow-up of 12 months.

45% (n=13/29) of responses to BAVENCIO lasted for at least 1 year

29 of 88 patients had a complete or partial response2

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In the JAVELIN Merkel 200 study2:

  • Tumor response assessments were performed every 6 weeks
  • 76% (n=22/29) of responses were seen by the first observation
  • 72% (n=21/29) of responses were ongoing at the time of data cutoff

Responses after at least 2 years of follow-up

In a subsequent analysis of the JAVELIN Merkel 200 study, with a minimum follow-up of 2 years (data cut-off on September 26, 2017), which did not account for censoring

  • 90% of responses lasted for at least 6 months (n=26/29; range: 2.8 to 31.8 months)
  • 66% of responses lasted for at least 1 year (n=19/29; range: 2.8 to 31.8 months)
  • 37% of responses lasted for at least 2 years (n=9/29; range: 2.8 to 31.8 months)

These data on durations of response are based on different data with a minimum of 2 years of follow-up in all patients (EMR 100070-003 Part A; cutoff date: September 26, 2017). The relative frequencies presented do not account for censoring. 

Adverse reactions (≥ 10%) from JAVELIN Merkel 200 trial

aFatigue is a composite term that includes fatigue and asthenia.

bInfusion-related reaction is a composite term that includes drug hypersensitivity, hypersensitivity, chills, pyrexia, back pain, and hypotension.

cPeripheral edema is a composite term that includes peripheral edema and peripheral swelling.

dMusculoskeletal pain is a composite term that includes back pain, myalgia, neck pain, and pain in extremity.

eAbdominal pain is a composite term that includes abdominal pain and abdominal pain upper.

fRash is a composite term that includes rash maculopapular, erythema, and dermatitis bullous.

gPruritus is a composite term that includes pruritis and pruritis generalized.

hDyspnea is a composite term that includes dyspnea and dyspnea exertional.

  • Serious adverse reactions that occurred in more than one patient were acute kidney injury, anemia, abdominal pain, ileus, asthenia, and cellulitis
  • The most common adverse reactions (≥ 20%) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%)
  • 7% (6/88) of patients permanently discontinued treatment due to adverse reactions
    • Adverse reactions resulting in permanent discontinuation were ileus, Grade 3 transaminitis, Grade 3 creatine kinase elevation, tubulointerstitial nephritis, and Grade 3 pericardial effusion
  • 24% (21/88) of patients temporarily discontinued treatment due to adverse events*
    • The most common adverse event requiring dose interruption was anemia

*Excluding temporary dose interruption for infusion-related reactions where infusion was restarted the same day.

The median duration of exposure to BAVENCIO was 4 months (range: 2 weeks to 21 months). 40% of patients received BAVENCIO for more than 6 months and 14% were treated for more than one year

No new safety signals were observed in a 2-year follow-up3

Avelumab (BAVENCIO)

RECOMMENDED by the National Comprehensive Cancer Network® (NCCN®) as an option for patients with disseminated Merkel cell carcinoma (category 2A)6

The NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Metastatic Merkel cell carcinoma (mMCC) is an aggressive disease with poor survival after distant metastasis7,8


Poor historical survival in metastatic MCC8

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MCC is rare, but the incidence is growing

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  • Patients with early-stage disease often experience recurrence and develop metastasis10,11

References: 1. US, National Library of Medicine. DailyMed: Advanced Search Indication And Usage Section (34067-9). https://dailymed.nlm.nih.gov/dailymed/advanced-search.cfm. Accessed April 2, 2018. 2. Data on file. Rockland, Mass: EMD Serono, Inc. 3. Nghiem P, Bhatia S, Brohl AS, et al. Two-year efficacy and safety update from JAVELIN Merkel 200 part A: a registrational study of avelumab in metastatic cell carcinoma progressed on chemotherapy. Presented at: 2018 American Society of Clinical Oncology Annual Meeting; June 1-5, 2018; Chicago, IL. Abstract 9507. 4. Kaufman HL, Russell J, Hamid O, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016;17(10):1374-1385. 5. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/results?cond=merkel+cell+carcinoma&term=immune&cntryl=&state1=&recrs=#wrapper. Accessed April 15, 2018. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Merkel Cell Carcinoma. V.1.2019. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed September 26, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. 7. Chapter 30, Merkel cell carcinoma. In: Edge SB, Byrd DR, Compton CC, et al, eds. AJCC Cancer Staging Manual. 7th ed. New York, NY: Springer, 2010:315-323. 8. Lemos BD Storer BE, Iyer JG, et al. Pathologic nodal evaluation improves prognostic accuracy in Merkel cell carcinoma: analysis of 5823 cases as the basis of the first consensus staging system. J Am Acad Dermatol. 2010;63(5):751-761. 9. Paulson KG, Park SY, Vandeven NA, et al. Merkel cell carcinoma: current US incidence and projected increases based on changing demographics. J Am Acad Dermatol. 2018;78:457-463. 10. Poulsen M, Rischin D, Walpole E, et at; Trans-Tasman Radiation Oncology Group. High-risk Merkel cell carcinoma of the skin treated with synchronous carboplatin/etoposide and radiation: a Trans-Tasman Radiation Oncology Group Study-TROG 96:07. J Clin Oncol. 2003;21(23):4371-4376. 11. Cowey CL, Mahnke L, Espirito J, et al. Real-world treatment outcomes in patients with metastatic Merkel cell carcinoma treated with chemotherapy in the USA. Future Oncol. 2017;13(19):1699-1710.