Response and Outcomes of Maintenance Avelumab After Platinum-Based Chemotherapy (PBC) in Patients With Advanced Urothelial Carcinoma (aUC): “Real World” Experience

Bakaloudi, Dimitra Rafailia; Talukder, Rafee; Lin, Genevieve Ihsiu; Makrakis, Dimitrios; Diamantopoulos, Leonidas N.; Tripathi, Nishita; Agarwal, Neeraj; Zakopoulou, Roubini; Bamias, Aristotelis; Brown, Jason R.; Pinato, David J.; Korolewicz, James; Jindal, Tanya; Koshkin, Vadim S.; Murgić, Jure; Miletić, Marija; Frobe, Ana; Johnson, Jeffrey; Zakharia, Yousef; Drakaki, Alexandra; Rodriguez-Vida, Alejo; Rey-Cárdenas, Macarena; Castellano, Daniel; Buznego, Lucia Alonso; Duran, Ignacio; Carballeira, Clara Castro; Barrera, Rafael Morales; Marmorejo, David; McKay, Rana R.; Stewart, Tyler; Gupta, Shilpa; Ruplin, Andrew Thomas; Yu, Evan Y.; Khaki, Ali R.; Grivas, Petros

doi:10.1016/j.clgc.2023.06.008

Cited by 8 publications

(4 citation statements)

References 33 publications

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“…Median PFS in this population was 7.9 months, which is numerically higher than the PFS of 5.5 months reported after long-term follow-up in the JAVELIN Bladder 100 trial ( 19 ). In other real-world studies of avelumab 1L maintenance treatment, median PFS ranged from 5.7 to 9.6 months ( 22 – 24 ). In this EAP population, subgroup analyses of outcomes were not performed because of the small number of patients.…”

Section: Discussionmentioning

confidence: 97%

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: Discussionmentioning

confidence: 97%

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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“…The efficacy of avelumab switch maintenance on SUC has rarely been reported in a real-world setting. In a multicenter retrospective study conducted in the United States and Europe, patients with SUC (n=23) showed no increased risk for poor OS or PFS compared with those with PUC (n=85) ( 22 ). Moreover, the AVENANCE study revealed that patients with SUC (n=44) had a median OS of 20.2 months and a 1-year OS rate of 65.3% ( 23 ).…”

Section: Discussionmentioning

confidence: 99%

Efficacy of avelumab maintenance therapy for advanced urothelial carcinoma with histologic subtype and divergent differentiation: a multicenter retrospective study conducted by the Uro-Oncology Group in Kyushu

Minato,

Furubayashi,

Tomoda

et al. 2024

Transl Androl Urol

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Background The subtype of urothelial carcinoma (SUC) has been known to possess morphological diversity for histologic subtype or divergent differentiation. However, the efficacy of avelumab against SUC remains unclear. Therefore, the effect of the treatment as well as the survival results of avelumab monotherapy were evaluated as a first-line therapeutic maintenance in patients with advanced SUC. Methods A retrospective analysis was conducted on consecutive patients from the Uro-Oncology Group in Kyushu study population with advanced lower and upper urinary tract cancer who underwent avelumab maintenance therapy without progression after first-line platinum-based chemotherapy. Patients with pure urothelial carcinoma (PUC) and SUC were comparatively analyzed based on objective response rate (ORR), disease control rate, progression-free survival (PFS), and overall survival (OS). Results Out of 49 recorded patients, 38 and 11 had PUC and SUC, respectively. The most common subtype element was glandular differentiation (n=5), followed by squamous differentiation (n=3), micropapillary (n=1), and plasmacytoid subtypes (n=1). The SUC and PUC groups had comparable ORR (0% vs. 2.6%, P>0.99) and disease control rates (54.5% vs. 44.7%, P=0.73). These patient groups also showed no significant difference in PFS (median 3.9 vs. 3.1 months, P=0.33) or OS (median 16.7 vs. 22.1 months, P=0.47). Conclusions The response of SUC and PUC to avelumab was comparable in patients with advanced lower and upper urinary tract cancer, indicating that avelumab maintenance therapy is also effective for SUC.

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“… 69 , 81 Efficacy and safety results from the JAVELIN Bladder 100 trial are also supported by noninterventional and retrospective studies. 82 , 83 , 84 …”

Section: Discussionmentioning

confidence: 99%

“…Median PFS was 9.6 months. 84 Data have also been reported from a small group of patients with advanced UC who received avelumab first-line maintenance in Japanese centers ( N = 27). The authors reported that the rate of disease control with avelumab first-line maintenance was higher in patients who had an interval between end of chemotherapy and start of avelumab of ≤6 weeks versus >6 weeks (77% versus 40%, respectively).…”

Section: Data For Avelumab First-line Maintenance Obtained Outside Of...mentioning

confidence: 99%

Avelumab first-line maintenance treatment for advanced urothelial carcinoma: review of evidence to guide clinical practice

Grivas,

Grande,

Davis

et al. 2023

ESMO Open

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Response and Outcomes of Maintenance Avelumab After Platinum-Based Chemotherapy (PBC) in Patients With Advanced Urothelial Carcinoma (aUC): “Real World” Experience

Cited by 8 publications

References 33 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

Efficacy of avelumab maintenance therapy for advanced urothelial carcinoma with histologic subtype and divergent differentiation: a multicenter retrospective study conducted by the Uro-Oncology Group in Kyushu

Avelumab first-line maintenance treatment for advanced urothelial carcinoma: review of evidence to guide clinical practice

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