653O Pembrolizumab (pembro) vs placebo as adjuvant therapy for patients (pts) with renal cell carcinoma (RCC): Patient-reported outcomes (PRO) in KEYNOTE-564

Choueiri, Toni K.; Tomczak, Piotr; Park, S.H.; Venugopal, Balaji; Symeonides, Stefan; Hájek, Jaroslav; Ferguson, Thomas; Yh, Chang; Lee, J.L.; Haas, Naomi B.; Sawrycki, Piotr; Sarwar, Naveed; Gross‐Goupil, Marine; Thiery-Vuillemin, A.; Mahave, Mauricio; Saretsky, T.; Zhang, P.; Willemann-Rogerio, Jaqueline; Quinn, David I.; Powles, Thomas

doi:10.1016/j.annonc.2021.08.049

Cited by 6 publications

(4 citation statements)

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“…The secondary endpoints of health-related quality of life and physical functioning by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire and disease symptoms by the Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms tools were previously published for the protocol-specified first interim analysis of the study (with a data cutoff date of Dec 14, 2020). 18,20…”

Section: Discussionmentioning

confidence: 99%

Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Chang

Burgents

et al. 2022

The Lancet Oncology

187

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Section: Discussionmentioning

confidence: 99%

Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Chang

Burgents

et al. 2022

The Lancet Oncology

187

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“…Наибольший выигрыш ОВ на фоне кабозантиниба с ниволумабом реализовался после удаления первичной опухоли (ОР 0,54; 95% ДИ 0,37-0,78), в то время как у пациентов, которым нефрэктомия не выполнялась, разница результатов между группами в отношении ОВ оказалась недостоверна. Интересно, что у больных с большой опухолевой нагрузкой (суммой диаметров таргетных очагов ≥72 мм) было зарегистрировано значимое увеличение ОВ в группе комбинации (ОР 0,64; 95% ДИ 0,46-0,89), в то время как при малой опухолевой нагрузке различия ОВ оказались недостоверны [29][30][31].…”

Section: кабозантиниб в комбинации с ниволумабом в 1-й линии терапии ...unclassified

Cabozantinib in the treatment of patients with advanced renal cell carcinoma

Volkova

Turupaev²,

Kalinin³

2022

J. Mod. Onco.

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In recent years, the standards of drug therapy for advanced kidney cancer have undergone significant changes associated with the appearance of the effective immune checkpoint inhibitors, as well as the high affinity second-generation multi-kinase inhibitors. One of the new tyrosine kinase inhibitors associated with the proven antitumor activity and safety in patients with advanced forms of renal cell carcinoma (RCC) is cabozantinib. The standards of drug therapy for advanced renal cancer have significantly changed in recent years with the emergence of effective anti-tumor immune response checkpoint inhibitors and high-affinity second-generation multikinase inhibitors. One of the novel tyrosine kinase inhibitors with proven antitumor activity and safety in patients with advanced renal cell cancer (RCC) is cabozantinib. In the first-line therapy for advanced renal cancer, the combination of cabozantinib with nivolumab became the regimen of choice in patients of all risk groups, according to International Metastatic RCC Database Consortium (IMDC), regardless of the presence of a sarcomatoid component in the tumor based on the results of the randomized phase III CheckMate 9ER clinical trial (n=651), which demonstrated a significant benefit of immune targeted therapy compared to sunitinib in terms of overall survival (OS; median 37.7 and 34.3 months, respectively), progression-free survival (PFS; median 16.6 and 8.3 months, respectively) and objective response rate (ORR; 55.7 and 28.4%, respectively). Cabozantinib monotherapy in the first-line therapy of advanced renal cancer in patients in the intermediate-risk and poor-risk groups is an alternative regimen reserved for patients with contraindications to anti-tumor immune response checkpoint inhibitors. This recommendation is based on the results of the open-label phase II RCT, CABOSUN (n=157), which showed a significant increase in PFS in the cabozantinib group compared to sunitinib (8.6 month vs 5.3 months, respectively). Also, cabozantinib is the drug of choice in papillary RCC due to the proven advantage in terms of PFS over sunitinib (9.0 and 5.6 months, respectively) demonstrated in the SWOG 1500 phase II RCT (n=152). Cabozantinib remains the drug of choice for second-line therapy of RCC resistant to anti-angiogenic therapy, based on the results of the phase III METEOR RCT, in which the drug showed a compelling advantage over everolimus for PFS (7.4 and 3.8 months, respectively) and OS (21.4 and 16.5 months, respectively). The article presents a detailed analysis of these studies.

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“…Immune checkpoint blockade (ICB) antibodies block the interactions between Programmed Death-1 (PD-1) expressed on activated and "exhausted" T cells and the PD-L1 ligand expressed on cancer cells and tumor-associated immune cells in the tumor microenvironment (TME) to unleash a T cell immune attack against cancer cells (1)(2)(3). ICB-targeted therapies have improved clinical outcomes in numerous clinical trials, and several are now approved for multiple cancer indications usually in combination with chemotherapy in the neoadjuvant and adjuvant settings (4)(5)(6)(7). While much success has been achieved using these agents, curative responses occur in only a fraction of patients.…”

Section: Introductionmentioning

confidence: 99%

Enhancement of anti-tumor efficacy of immune checkpoint blockade by alpha-TEA

Redmond

Kasiewicz²,

Akporiaye³

2023

Front. Immunol.

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Cancer immunotherapy such as anti-PD-1/anti-PD-L1 immune checkpoint blockade (ICB) can provide significant clinical benefit in patients with advanced malignancies. However, most patients eventually develop progressive disease, thus necessitating additional therapeutic options. We have developed a novel agent, a-TEA-LS, that selectively induces tumor cell death while sparing healthy tissues, leading to increased activation of tumor-reactive T cells and tumor regression. In the current study, we explored the impact of combined a-TEA-LS + ICB in orthotopic and spontaneously arising murine models of mammary carcinoma. We found that a-TEA-LS + ICB led to increased production of pro-inflammatory cytokines that were associated with a reduction in tumor growth and prolonged survival. Together, these data demonstrate the potential utility of a-TEA-LS + ICB for the treatment of breast cancer and provide the rationale for clinical translation of this novel approach.

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653O Pembrolizumab (pembro) vs placebo as adjuvant therapy for patients (pts) with renal cell carcinoma (RCC): Patient-reported outcomes (PRO) in KEYNOTE-564

Cited by 6 publications

References 0 publications

Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Cabozantinib in the treatment of patients with advanced renal cell carcinoma

Enhancement of anti-tumor efficacy of immune checkpoint blockade by alpha-TEA

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