Results from the INMUNOSUN-SOGUG trial: a prospective phase II study of sunitinib as a second-line therapy in patients with metastatic renal cell carcinoma after immune checkpoint-based combination therapy

Grande, Enrique; Alonso‐Gordoa, Teresa; Reig, Òscar; Esteban, Emilio; Castellano, Daniel; García‐del‐Muro, Xavier; Méndez, María José; García-Donás, Jesús; Rodriguez, M. Gonzalez; Arranz-Arija, J.A.; López-Criado, Pilar; Molina‐Cerrillo, Javier; Mellado, Begoña; Álvarez-Fernández, Carlos; Velasco, Guillermo; Cuéllar-Rivas, M A; Rodríguez-Alonso, R M; Rodriguez-Moreno, Juan Francisco; C, Suárez-Rodríguez

doi:10.1016/j.esmoop.2022.100463

Cited by 10 publications

(8 citation statements)

References 31 publications

(53 reference statements)

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“…Prospective data have also been published from small phase II trials with axitinib [ 102 ], cabozantinib [ 103 ], and sunitinib [ 104 ]. A phase II trial with dose escalation of axitinib was carried out in 40 patients who had received checkpoint inhibitor therapy as the most recent treatment.…”

Section: Second-line Treatment and Sequencesmentioning

confidence: 99%

See 1 more Smart Citation

SEOM SOGUG clinical guideline for treatment of kidney cancer (2022)

Méndez-Vidal,

Lázaro Quintela,

Lainez-Milagro

et al. 2023

Clin Transl Oncol

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Renal cancer is the seventh most common cancer in men and the tenth in women. The aim of this article is to review the diagnosis, treatment, and follow-up of renal carcinoma accompanied by recommendations with new evidence and treatment algorithms. A new pathologic classification of RCC by the World Health Organization (WHO) was published in 2022 and this classification would be considered a “bridge” to a future molecular classification. For patients with localized disease, surgery is the treatment of choice with nephron-sparing surgery recommended when feasible. Adjuvant treatment with pembrolizumab is an option for intermediate-or high-risk cases, as well as patients after complete resection of metastatic disease. More data are needed in the future, including positive overall survival data. Clinical prognostic classification, preferably IMDC, should be used for treatment decision making in mRCC. Cytoreductive nephrectomy should not be deemed mandatory in individuals with intermediate-poor IMDC/MSKCC risk who require systemic therapy. Metastasectomy can be contemplated in selected subjects with a limited number of metastases or long metachronous disease-free interval. For the population of patients with metastatic ccRCC as a whole, the combination of pembrolizumab–axitinib, nivolumab–cabozantinib, or pembrolizumab–lenvatinib can be considered as the first option based on the benefit obtained in OS versus sunitinib. In cases that have an intermediate IMDC and poor prognosis, the combination of ipilimumab and nivolumab has demonstrated superior OS compared to sunitinib. As for individuals with advanced RCC previously treated with one or two antiangiogenic tyrosine-kinase inhibitors, nivolumab and cabozantinib are the options of choice. When there is progression following initial immunotherapy-based treatment, we recommend treatment with an antiangiogenic tyrosine-kinase inhibitor. While no clear sequence can be advocated, medical oncologists and patients should be aware of the recent advances and new strategies that improve survival and quality of life in the setting of metastatic RC.

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Section: Second-line Treatment and Sequencesmentioning

confidence: 99%

“…In the Immunosun trial, subjects who had progressed following a first-line regimen consisting of an ICI-based therapy were treated with sunitinib. PFS and ORR were 5.6 months and 19%, respectively [ 104 ].…”

Section: Second-line Treatment and Sequencesmentioning

confidence: 99%

SEOM SOGUG clinical guideline for treatment of kidney cancer (2022)

Méndez-Vidal,

Lázaro Quintela,

Lainez-Milagro

et al. 2023

Clin Transl Oncol

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“…In the ICI-based frontline therapy era, prospective evaluation of sunitinib as a second-line agent in the INMUNOSUN-SOGUG phase II trial has yielded a median PFS of 5.6 months and OS of 23.5 months ( 15 ). Importantly, those patients who demonstrated better responses to first-line ICI-based therapies were also the ones who benefited the most from sunitinib ( 15 ). A larger, real-world retrospective study of 102 patients confirmed the activity of second-line sunitinib following immunotherapy, showing an objective response rate (ORR) of 22.5%, a median time to treatment discontinuation of 5.4 months, and a median OS of 15.6 months ( 16 ).…”

Section: Second-line Anti-angiogenic Therapiesmentioning

confidence: 99%

“…The introduction of novel with sunitinib as third-line treatment and beyond has also shown efficacy supported by a median PFS of 7.9 months (14). In the ICI-based frontline therapy era, prospective evaluation of sunitinib as a second-line agent in the INMUNOSUN-SOGUG phase II trial has yielded a median PFS of 5.6 months and OS of 23.5 months (15). Importantly, those patients who demonstrated better responses to first-line ICI-based therapies were also the ones who benefited the most from sunitinib (15).…”

Section: Introductionmentioning

confidence: 99%

Current Options for Second-Line Systemic Therapy in Metastatic Renal Cell Carcinoma

Mitsogiannis

Mitsogianni²,

Papathanassiou³

et al. 2022

jkcvhl

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Standard systemic therapy of advanced renal cell carcinoma (RCC) involves targeting angiogenesis, mainly through tyrosine kinase inhibitors (TKI) against the vascular endothelial growth factor receptor (VEGFR) pathway and targeting the immune checkpoints, namely, programmed death-1 (PD-1) or its ligand (PD-L1), and cytotoxic T-lymphocyte-associated protein 4 (CTLA4). With current strategies of combining these two approaches in the front-line setting, less is known about optimal selection of therapy upon development of resistance in the second and later lines of treatment for progressive disease. This review discusses currently available therapeutic options in patients who have progressive RCC after prior treatment with double immune checkpoint inhibitors (ICIs) or ICI-TKI combinations.

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“…Despite these clear advantages, most patients experience disease progression, requiring the choice of a new systemic treatment. Prospective data to determine the efficacy of further treatments after an ICI-based first-line therapy are lacking and are limited to small phase II trials focused on the use of TKI [ 9 , 10 , 11 , 12 ]. The role of ICI rechallenge (defined as the reintroduction of an ICI-based therapy after disease progression to previous ICI therapy) in this setting remains unclear; this strategy is not currently considered a standard of care in the treatment of advanced RCC, but it may be a reasonable option according to clinical activity data from other diseases, such as advanced melanoma [ 13 ] and non-small cell lung cancer (NSCLC) [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

Immune Checkpoint Inhibitor Rechallenge in Renal Cell Carcinoma: Current Evidence and Future Directions

Sammarco,

Manfredi,

Nuzzo

et al. 2023

Cancers

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Immune checkpoint inhibitor-based therapies represent the current standard of care in the first-line treatment of advanced renal cell carcinoma. Despite a clear benefit in survival outcomes, a considerable proportion of patients experience disease progression; prospective data about second-line therapy after first-line treatment with immune checkpoint inhibitors are limited to small phase II studies. As with other solid tumors (such as melanoma and non-small cell lung cancer), preliminary data about the clinical efficacy of rechallenge of immunotherapy (alone or in combination with other drugs) in renal cell carcinoma are beginning to emerge. Nevertheless, the role of rechallenge in immunotherapy in this setting of disease remains unclear and cannot be considered a standard of care; currently some randomized trials are exploring this approach in patients with metastatic renal cell carcinoma. The aim of our review is to summarize main evidence available in the literature concerning immunotherapy rechallenge in renal carcinoma, especially focusing on biological rationale of resistance to immune checkpoint inhibitors, on the published data of clinical efficacy and on future perspectives.

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Results from the INMUNOSUN-SOGUG trial: a prospective phase II study of sunitinib as a second-line therapy in patients with metastatic renal cell carcinoma after immune checkpoint-based combination therapy

Cited by 10 publications

References 31 publications

SEOM SOGUG clinical guideline for treatment of kidney cancer (2022)

SEOM SOGUG clinical guideline for treatment of kidney cancer (2022)

Current Options for Second-Line Systemic Therapy in Metastatic Renal Cell Carcinoma

Immune Checkpoint Inhibitor Rechallenge in Renal Cell Carcinoma: Current Evidence and Future Directions

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