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

Grivas, P.; Grande, E.; Davis, I.D.; Moon, H.H.; Grimm, M.-O.; Gupta, S.; Barthélémy, P.; Thibault, C.; Guenther, S.; Hanson, S.; Sternberg, C.N.

doi:10.1016/j.esmoop.2023.102050

Cited by 7 publications

(4 citation statements)

References 87 publications

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“…Given the short duration of PFS (median: 3.8–4.9 months) from the introduction of platinum-based chemotherapy in previous studies ( 24 , 25 ), early sequential therapy (switching to no more than four cycles) from first-line chemotherapy to avelumab maintenance therapy may be suitable for patients with advanced SUC. The DISCUS trial (EudraCT Number 2021-001975-17), an ongoing randomized trial that compares 3 and 6 cycles of platinum-based chemotherapy followed by avelumab, will help further refine the appropriate timing of switch maintenance ( 26 ).…”

Section: Discussionmentioning

confidence: 99%

“…Although PD-L1 was analyzed in the JAVELIN Bladder 100 population ( 7 ), molecular biomarkers are not routinely used in daily practice in Japan. Currently, PD-L1 status is not clinically required to be assessed when considering avelumab maintenance therapy ( 26 ). The ARIES trial found no difference in avelumab response between patients with high and low PD-L1 expression levels ( 32 ).…”

Section: Discussionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

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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“… 1319 Avelumab is a fully human IgG1 mAb with a wild-type IgG1 crystallizable fragment (Fc) region, which enables avelumab to utilize both adaptive and innate immune mechanisms to suppress cancer cells. 1320 Similarly, avelumab obtained accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma in 2017, and subsequently approval for first-line treatment of patients with advanced RCC in combination with axitinib in 2019. 1320 Compared with many oncology regimens, PD-1/PD-L1 blockade is associated with fewer adverse events including fatigue, diarrhea, and decreased appetite which are well tolerated.…”

Section: Tumor Biomarker-based Cancer Therapymentioning

confidence: 99%

“… 1320 Similarly, avelumab obtained accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma in 2017, and subsequently approval for first-line treatment of patients with advanced RCC in combination with axitinib in 2019. 1320 Compared with many oncology regimens, PD-1/PD-L1 blockade is associated with fewer adverse events including fatigue, diarrhea, and decreased appetite which are well tolerated. Moreover, there are still a large number of clinical trials undergoing to evaluate the therapeutic potential of the above inhibitors.…”

Section: Tumor Biomarker-based Cancer Therapymentioning

confidence: 99%

Tumor biomarkers for diagnosis, prognosis and targeted therapy

Zhou,

Tao,

Qiu

et al. 2024

Sig Transduct Target Ther

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Tumor biomarkers, the substances which are produced by tumors or the body’s responses to tumors during tumorigenesis and progression, have been demonstrated to possess critical and encouraging value in screening and early diagnosis, prognosis prediction, recurrence detection, and therapeutic efficacy monitoring of cancers. Over the past decades, continuous progress has been made in exploring and discovering novel, sensitive, specific, and accurate tumor biomarkers, which has significantly promoted personalized medicine and improved the outcomes of cancer patients, especially advances in molecular biology technologies developed for the detection of tumor biomarkers. Herein, we summarize the discovery and development of tumor biomarkers, including the history of tumor biomarkers, the conventional and innovative technologies used for biomarker discovery and detection, the classification of tumor biomarkers based on tissue origins, and the application of tumor biomarkers in clinical cancer management. In particular, we highlight the recent advancements in biomarker-based anticancer-targeted therapies which are emerging as breakthroughs and promising cancer therapeutic strategies. We also discuss limitations and challenges that need to be addressed and provide insights and perspectives to turn challenges into opportunities in this field. Collectively, the discovery and application of multiple tumor biomarkers emphasized in this review may provide guidance on improved precision medicine, broaden horizons in future research directions, and expedite the clinical classification of cancer patients according to their molecular biomarkers rather than organs of origin.

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Experience and Prognostic Analysis with Avelumab Switch Maintenance Treatment in Metastatic Urothelial Carcinoma

Isobe,

Naiki,

Sugiyama

et al. 2024

Oncology

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Introduction: Avelumab is approved for metastatic urothelial carcinoma (mUC) maintenance therapy and prolongs overall survival (OS). We explored trends related to avelumab treatment of mUC patients. Methods: A total of 72 patients with mUC treated with first-line chemotherapy, from January 2019 to November 2022, at our affiliated institutions, were analyzed. We compared clinical parameters and the prognosis of patients treated with avelumab (Ave; n=43), because of progression during first-line chemotherapy, with untreated patients (Ave-untreated; n=29). Among the Ave-treated group, we classified patients showing a complete or partial response or stable disease in their best response to avelumab maintenance therapy as avelumab (Ave)-suitable patients; these were retrospectively analyzed. Potential prognostic factors, including the geriatric nutritional risk index (GNRI) for determining patients suitable for Ave, were evaluated. Results: The basic clinical parameters of patients when first-line treatment was initiated were not statistically different between the two groups. The Ave-suitable group (median 26.6 months, 95% confidence interval [CI]: 19.4–not reached [NR]) showed significantly longer median OS after first-line treatment than the Ave-untreated group (median 12.0 months, 95% CI: 7.5–NR) with tolerable adverse events. The cut-off values of prognostic factors were set by receiver operating characteristic curve. Low age and GNRI sustainability revealed as significant prognostic factors for being Ave-suitable both in univariate and multivariate analysis. Conclusion: In mUC, avelumab maintenance prolonged OS within tolerable safety profiles. GNRI sustainability may be used as biomarker to predict being Ave-suitable.

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

Cited by 7 publications

References 87 publications

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

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

Tumor biomarkers for diagnosis, prognosis and targeted therapy

Experience and Prognostic Analysis with Avelumab Switch Maintenance Treatment in Metastatic Urothelial Carcinoma

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