Avelumab first-line maintenance plus best supportive care (BSC) vs. BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Asian subgroup analysis

Lee, Jae‐Lyun; Desai, Chirag; Park, Se Hoon; Tsuchiya, Norihiko; Su, Po‐Jung; Chan, Timothy Tim Wai; Gao, Seasea; Wang, Jing; Sandner, Robin; Pietro, Alessandra di; Eto, Masatoshi

doi:10.1016/j.urolonc.2023.02.002

Cited by 5 publications

(5 citation statements)

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“…In a post hoc analysis, median OS with avelumab 1L maintenance treatment measured from the start of 1L platinum-based chemotherapy in this population without PD was 29.7 months ( 20 ). In a subgroup analysis of patients enrolled in Asian countries, efficacy and safety findings were generally consistent with those observed in the overall population ( 21 ). Furthermore, prospective and retrospective real-world studies conducted in several countries have confirmed the favorable clinical activity and acceptable safety profile of avelumab 1L maintenance treatment reported in the JAVELIN Bladder 100 trial ( 22 – 25 ).…”

Section: Introductionsupporting

confidence: 73%

“…Nevertheless, in the JAVELIN Bladder 100 trial, HRs for OS and PFS favored avelumab 1L maintenance + BSC vs BSC alone in patients with visceral metastases (18,19,28). The most common 1L chemotherapy regimen in the EAP population was cisplatin + gemcitabine, consistent with the Asian subgroup of JAVELIN Bladder 100 (21). The number of cycles of 1L platinum-based chemotherapy received in the EAP population ranged from 4 to 6 in 97% of patients, which aligns with international guidelines and the design of the JAVELIN Bladder 100 study (3, 9, 10, 18).…”

Section: Discussionmentioning

confidence: 86%

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Avelumab first-line maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma: real-world results from a Korean expanded access program

Park,

Shin,

Rha

et al. 2024

Front. Oncol.

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BackgroundThe JAVELIN Bladder 100 phase 3 trial demonstrated the efficacy and safety of avelumab administered as first-line (1L) maintenance treatment in patients with advanced urothelial carcinoma (UC) without disease progression after 1L platinum-based chemotherapy. This study provides the first real-world data from Korea regarding avelumab 1L maintenance treatment, comprising data obtained from a nationwide expanded access program (EAP).MethodsThis open-label EAP was conducted at five centers from September 2021 until June 2023. Eligible patients had unresectable locally advanced or metastatic UC and were progression free after 1L platinum-based chemotherapy. Patients received avelumab 10 mg/kg intravenously every 2 weeks per local prescribing information. Safety and effectiveness were assessed by treating physicians according to routine practice.ResultsOverall, 30 patients were enrolled. At initial UC diagnosis, 20 patients (66.7%) had stage 4 disease and 12 (40.0%) had visceral metastases. The most common 1L chemotherapy regimen was gemcitabine + cisplatin (21 patients; 70.0%). All but one patient (96.7%) had received 4-6 cycles of 1L chemotherapy. The median interval from end of 1L chemotherapy to start of avelumab was 4.4 weeks. Median duration of avelumab treatment was 6.2 months (range, 0.9-20.7); nine patients (30.0%) received >12 months of treatment. Adverse events related to avelumab occurred in 21 patients (70.0%) and were grade ≥3 or classified as serious in three patients (10.0%). Median progression-free survival was 7.9 months (95% CI, 4.3-13.1). Overall survival was not analyzed because only one patient died.ConclusionResults from this EAP demonstrated the clinical activity and acceptable safety of avelumab 1L maintenance treatment in Korean patients with advanced UC, consistent with previous studies.

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Section: Introductionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 86%

Avelumab first-line maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma: real-world results from a Korean expanded access program

Park,

Shin,

Rha

et al. 2024

Front. Oncol.

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“…Results led to the approval of avelumab 1L maintenance therapy in patients with aUC that has not progressed with platinum‐based chemotherapy in various countries, and provided level 1 evidence to support its incorporation into international treatment guidelines as a standard of care 3,12,13 . In subgroup analyses of JAVELIN Bladder 100 in patients enrolled in Asian countries (21.0% of patients) or Japan (10.4% of patients), safety and efficacy results were generally consistent with overall trial findings 18,19 . These analyses supported the regulatory approval of avelumab in Japan in February 2021 as maintenance therapy following chemotherapy for curatively unresectable UC.…”

Section: Introductionmentioning

confidence: 72%

J‐AVENUE: A retrospective, real‐world study evaluating patient characteristics and outcomes in patients with advanced urothelial carcinoma treated with avelumab first‐line maintenance therapy in Japan

Kikuchi,

Hayakawa,

Nakayama

et al. 2024

Int J of Urology

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ObjectivesThe JAVELIN Bladder 100 phase 3 trial showed that avelumab first‐line maintenance + best supportive care significantly prolonged overall survival and progression‐free survival versus best supportive care alone in patients with advanced urothelial carcinoma who were progression‐free following first‐line platinum‐based chemotherapy. We report findings from J‐AVENUE (NCT05431777), a real‐world study of avelumab first‐line maintenance therapy in Japan.MethodsMedical charts of patients with advanced urothelial carcinoma without disease progression following first‐line platinum‐based chemotherapy, who received avelumab maintenance between February and November 2021, were reviewed. Patients were followed until June 2022. The primary endpoint was patient characteristics; secondary endpoints included time to treatment failure and progression‐free survival.ResultsIn 79 patients analyzed, median age was 72 years (range, 44–86). Primary tumor site was upper tract in 45.6% and bladder in 54.4%. The most common first‐line chemotherapy regimen was cisplatin + gemcitabine (63.3%). Median number of chemotherapy cycles received was four. Best response to chemotherapy was complete response in 10.1%, partial response in 58.2%, and stable disease in 31.6%. Median treatment‐free interval before avelumab was 4.9 weeks. With avelumab first‐line maintenance therapy, the disease control rate was 58.2%, median time to treatment failure was 4.6 months (95% CI, 3.3–6.4), and median progression‐free survival was 6.1 months (95% CI, 3.6–9.7).ConclusionsFindings from J‐AVENUE show the effectiveness of avelumab first‐line maintenance in patients with advanced urothelial carcinoma in Japan in clinical practice, with similar progression‐free survival to JAVELIN Bladder 100 and previous real‐world studies, supporting its use as a standard of care.

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“…For stage IIIB MIBC patients, treatment typically involves either upfront systemic chemotherapy (with consideration of consolidative local therapy) or cCRT (5). Additionally, the use of avelumab as a "switch" maintenance therapy can be offered to patients with unresectable node-positive BC who achieved at least stable disease following initial chemotherapy (12,14).…”

Section: Discussionmentioning

confidence: 99%

Avelumab maintenance therapy for node-positive muscle invasive bladder cancer: a report of two cases

Poon,

Ho,

Kwong

2024

Front. Oncol.

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BackgroundMuscle-invasive bladder cancer (MIBC) with nodal involvement is associated with poor prognosis and high mortality. Treatment of node-positive MIBC is complex due to disease heterogeneity and a lack of evidence-based treatment options, especially alternatives to radical cystectomy. We describe a bladder-sparing management approach involving systemic therapy followed by maintenance therapy, illustrated with two cases of node-positive MIBC.Case presentationTwo patients with node-positive MIBC received upfront gemcitabine/cisplatin chemotherapy, concurrent chemoradiotherapy (cCRT), and avelumab (immune checkpoint inhibitor) maintenance therapy. Both patients achieved complete remission without recurrence or distant metastasis post-avelumab maintenance therapy. At the last follow-up, Patient 1 (45-year-old male) was in remission for over two years, and Patient 2 (57-year-old male) was in complete remission for over one year post-chemotherapy. Avelumab treatment was well-tolerated, with no immune-related adverse events, and quality of life (QoL) was maintained.ConclusionBoth cases showed a good response and extended remission on avelumab maintenance, supporting its use in conjunction with local consolidation therapy as a bladder-preserving approach in node-positive MIBC. Further research, such as the ongoing INSPIRE trial, is required to refine treatment strategies for this patient group.

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Avelumab first-line maintenance plus best supportive care (BSC) vs. BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Asian subgroup analysis

Cited by 5 publications

References 13 publications

Avelumab first-line maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma: real-world results from a Korean expanded access program

Avelumab first-line maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma: real-world results from a Korean expanded access program

J‐AVENUE: A retrospective, real‐world study evaluating patient characteristics and outcomes in patients with advanced urothelial carcinoma treated with avelumab first‐line maintenance therapy in Japan

Avelumab maintenance therapy for node-positive muscle invasive bladder cancer: a report of two cases

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