Real-World Clinical Outcomes with First-Line Avelumab in Locally Advanced/metastatic Merkel Cell Carcinoma in the USA: SPEAR-Merkel

Cowey, C. Lance; Liu, Frank X.; Kim, Ruth; Boyd, Marley; Fulcher, Nicole; Krulewicz, Stan; Kasturi, Vijay; Bhanegaonkar, Abhijeet

doi:10.2217/fon-2020-1250

Cited by 12 publications

(9 citation statements)

References 18 publications

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“…[9][10][11] The real-world SPEAR-Merkel study examined clinical outcomes in patients with locallyadvanced MCC (laMCC) or mMCC, restricted to patients initiating 1L avelumab in a US community oncology setting. 20 The population in SPEAR-Merkel appears to have had less severe disease than our study's population, with 14.3% stage IIIB, 21.4% stage IV, 50% ECOG PS 1, 11% ECOG PS 2, and no ECOG PS 3 (compared with this study's population: 18% stage IIIB, 82% stage IV, 31% ECOG PS 1, 42% ECOG PS 2, and 26% ECOG PS 3). In another real-world study, Levy et al 21 assessed outcomes of patients with advanced MCC, defined as stage IIIB or stage IV, treated with avelumab in four dedicated referral centers in the Netherlands.…”

Section: Discussioncontrasting

confidence: 53%

“…Patients with mMCC in SPEAR-Merkel experienced an rwORR of 63.2% in the USA, while they achieved a response rate of 59% (n=27) among patients with mMCC in Netherlands and an rwORR of 67.6% in patients with stage IV MCC in our study. 20 21 The median OS of the mMCC population in the SPEAR-Merkel study was 20.2 months, compared with a median OS of 25.8 months for the overall sample (not reported by mMCC) in the Levy et al study and 15.9 months for patients with stage IV disease in our study. 20 21 Focusing on patients with laMCC, rwORR was 66.7% in SPEAR-Merkel compared with a ORR of 50% in patients with laMCC in Levy et al and a 100% rwORR in patients with stage IIIB disease in our study.…”

Section: Discussioncontrasting

confidence: 51%

“… 20 21 The median OS of the mMCC population in the SPEAR-Merkel study was 20.2 months, compared with a median OS of 25.8 months for the overall sample (not reported by mMCC) in the Levy et al study and 15.9 months for patients with stage IV disease in our study. 20 21 Focusing on patients with laMCC, rwORR was 66.7% in SPEAR-Merkel compared with a ORR of 50% in patients with laMCC in Levy et al and a 100% rwORR in patients with stage IIIB disease in our study. 20 21 For laMCC, the median OS was not reached in the SPEAR-Merkel study and our study, and it was not reported in the Levy et al study.…”

Section: Discussioncontrasting

confidence: 51%

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Real-world clinical outcomes with avelumab in patients with Merkel cell carcinoma treated in the USA: a multicenter chart review study

Bhatia

Nghiem

Veeranki³

et al. 2022

J Immunother Cancer

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BackgroundMerkel cell carcinoma (MCC) is a rare, aggressive, cutaneous neuroendocrine neoplasm with annual incidence rates of 0.13–1.6 cases/100,000/year worldwide as of 2018. Chemotherapy for metastatic MCC (mMCC) has high objective response rates (ORRs), but responses are not durable and overall survival (OS) is poor. Avelumab (anti-programmed death-ligand 1) has demonstrated meaningful survival benefit and durable responses in clinical trials for mMCC. This study investigated real-world clinical outcomes in avelumab-treated patients with advanced (stage IIIB/IV) MCC in US academic medical centers.MethodsWe conducted a retrospective chart review of patients with advanced MCC who initiated avelumab between March 1, 2017, and July 31, 2019, at six US academic centers. Data were requested for eligible patients from index date through December 31, 2020. Descriptive analyses were conducted to assess demographic and clinical characteristics, real-world ORR (rwORR), real-world duration of response, real-world progression-free survival (rwPFS), and OS.ResultsNinety patients with advanced MCC (82%, stage IV; 18%, stage IIIB) received avelumab. Median follow-up was 20.8 months (95% CI: 19.1 to 24.2). Median age was 68 years (range, 48–83), and the majority of patients were men (58%) and white (93%). The primary tumor was most commonly located on the lower limb (38%), with metastases mostly located in lymph nodes (68%), lung (52%), and viscera (52%). Approximately 42% and 26% of patients had an Eastern Cooperative Oncology Group performance status of 2 and 3, respectively. Seventy-three patients (81%) received avelumab as first-line treatment of advanced MCC, while 17 (19%) received avelumab as second-line or later treatment. The median duration of avelumab treatment was 13.5 months (95% CI: 6.4 to 30.6), with 42% of patients still receiving avelumab by the end of follow-up. Patients with avelumab treatment had an rwORR of 73% (95% CI: 64 to 83), median rwPFS of 24.4 months (95% CI: 8.31 to not estimable (NE)), and median OS of 30.7 months (95% CI: 11.2 to NE).ConclusionsThis real-world study of patients with advanced MCC demonstrated that avelumab treatment resulted in a high response rate with durable responses and prolonged survival. The study findings validate the results demonstrated in prospective clinical trials and other observational studies.

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Section: Discussioncontrasting

confidence: 53%

Section: Discussioncontrasting

confidence: 51%

Section: Discussioncontrasting

confidence: 51%

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Real-world clinical outcomes with avelumab in patients with Merkel cell carcinoma treated in the USA: a multicenter chart review study

Bhatia

Nghiem

Veeranki³

et al. 2022

J Immunother Cancer

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“…Patients with avelumab treatment (n=90) had a rwORR of 73% (95% CI, 64-83), median rwPFS of 24.4 months (95% CI, 8. 3 2 and other recent observational studies. 3 4…”

mentioning

confidence: 68%

628 Real-world clinical outcomes among patients with advanced Merkel cell carcinoma treated with avelumab in academic medical centers in the United States

Bhatia

Nghiem²,

Veeranki³

et al. 2021

Regular and Young Investigator Award Abstracts

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BackgroundMerkel cell carcinoma (MCC) is a rare, aggressive cutaneous neuroendocrine neoplasm with annual incidence rates ranging from 0.13 to 1.6 cases per 100,000 per year.1 Chemotherapy for metastatic MCC (mMCC) has high objective response rates (ORRs), but responses are not durable and overall survival (OS) is poor. In March 2017, avelumab (anti–PD-L1) was approved for the treatment of mMCC and has demonstrated meaningful survival benefit and durable response.2 This study sought to investigate real-world clinical outcomes of avelumab-treated patients with advanced (stage IIIB/IV) MCC in academic medical centers in the United States (US).MethodsA retrospective chart review study of patients with advanced MCC who initiated avelumab between March 1, 2017, and July 31, 2019 was conducted at 6 US academic medical centers across the 4 US census regions. Eligible patients were followed through December 30, 2020. Descriptive analyses were conducted to assess demographics, clinical characteristics, and outcomes. Kaplan-Meier curves were constructed to illustrate real-world duration of response (rwDOR), real-world progression free survival (rwPFS), OS, and time-to-treatment discontinuation.ResultsNinety patients with advanced MCC were treated with avelumab, with a median follow-up of 15.0 months (95% CI, 13.1–17.8). Median age was 68 years; the majority were male (58%) and White (93%). During the time of avelumab initiation, 74 patients had stage IV MCC and 16 patients had stage IIIB MCC. Primary tumor was located most commonly on the lower limb (38%), with metastasis primarily to lymph nodes (67%) and lung (52%); 52% of patients had visceral metastases. Approximately 42% and 26% of patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 2 and 3, respectively. Seventy-three patients (81%) received avelumab as first-line treatment of advanced MCC, whereas 17 (19%) received avelumab as second-line or later. Median duration of avelumab treatment was 13.5 months (95% CI, 6.4–30.6); 58% discontinued by the end of follow-up. Patients with avelumab treatment (n=90) had a rwORR of 73% (95% CI, 64–83), median rwPFS of 24.4 months (95% CI, 8.3-not reached [NR]), and median OS of 30.7 months (95% CI, 11.2-NR). Other clinical outcomes by line of avelumab treatment and stage at avelumab initiation are reported in table 1.ConclusionsThis real-world study of patients with advanced MCC treated with avelumab demonstrates high response rate with durable responses and prolonged survival. The study findings are consistent with the efficacy results demonstrated in pivotal clinical trials2 and other recent observational studies.3 4AcknowledgementsThe authors would like to acknowledge all physicians at the respective sites who participated in the data collection process for the study.ReferencesMüller-Richter UDA, Gesierich A, Kübler AC, Hartmann S, Brands RC. Merkel cell carcinoma of the head and neck: recommendations for diagnostics and treatment. Ann Surg Oncol 2017;24:3430–3437.D'Angelo SP, Bhatia S, Brohl AS, et al. Avelumab in patients with previously treated metastatic Merkel cell carcinoma: long-term data and biomarker analyses from the single-arm phase 2 JAVELIN Merkel 200 trial. J Immunother Cancer 2020;8:e000674.Cowey CL, Liu FX, Kim R, et al. Real-world clinical outcomes with first-line avelumab in locally advanced/metastatic Merkel cell carcinoma in the USA: SPEAR-Merkel. Future Oncol 2021;17:2339–2350.Levy S, Aarts MJB, Eskens FALM, et al. Avelumab for advanced Merkel cell carcinoma in the Netherlands: a real-world cohort. J Immunother Cancer 2020;8:e001076.Ethics ApprovalThe study was approved by New England Institutional Review Board.Abstract 628 Table 1Clinical outcomes among avelumab-treated patients with advanced MCC by line-of-treatment and stage at avelumab initiation

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“…In the PD-L1-positive and PD-L1-negative subgroups, 1-y OS rates were 71% and 56%, respectively. The SPEAR-Merkel study has been published in 2021 and reported clinical outcomes in patients affected by locally advanced or metastatic MCC treated with avelumab first line, in a real-world setting ( 84 ). A total of 36 patients were enrolled, 28 (32.1%) with laMCC and 19 (67.9%) with mMCC.…”

Section: Systemic Therapy For Advanced Patientsmentioning

confidence: 99%

Merkel Cell Carcinoma: An Immunotherapy Fairy-Tale?

et al. 2021

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Merkel cell carcinoma (MCC) is a rare, highly aggressive, neuroendocrine cutaneous tumor. The incidence of MCC is growing worldwide, and the disease-related mortality is about three-fold higher than melanoma. Since a few years ago, very little has been known about this disease, and chemotherapy has been the standard of care. Nowadays, new discoveries about the pathophysiology of this neoplasm and the introduction of immunotherapy allowed to completely rewrite the history of these patients. In this review, we provide a summary of the most important changes in the management of Merkel cell carcinoma, with a focus on immunotherapy and a landscape of future treatment strategies.

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Real-World Clinical Outcomes with First-Line Avelumab in Locally Advanced/metastatic Merkel Cell Carcinoma in the USA: SPEAR-Merkel

Cited by 12 publications

References 18 publications

Real-world clinical outcomes with avelumab in patients with Merkel cell carcinoma treated in the USA: a multicenter chart review study

Real-world clinical outcomes with avelumab in patients with Merkel cell carcinoma treated in the USA: a multicenter chart review study

628 Real-world clinical outcomes among patients with advanced Merkel cell carcinoma treated with avelumab in academic medical centers in the United States

Merkel Cell Carcinoma: An Immunotherapy Fairy-Tale?

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