Update 1 juni 2020: Bron: ASCO post 2020

Dr. Sumanta Pal, hoofdredacteur van het PracticeUpdate Center of Excellence niercelcarcinoom, beveelt de volgende abstracten aan die specifiek gerelateerd zijn aan nierkanker die zijn gepresenteerd op het ASCO Genitourinary Symposium op 13-15 februari 2020 in San Francisco.

Klik op de nummers voor de abstracten:

Saturday, February 15, 2020; 7:00 AM–7:55 AM
Poster Session C: Renal Cell Cancer

645 Progression-free survival (PFS) and overall survival (OS) across ethnicities for patients with metastatic renal cell carcinoma (mRCC) receiving targeted therapies (TT) as first-line (1L) treatment. N Salgia, Nazli Dizman, PG Bergerot, et al

Conclusions:The lack of a statistically significant difference in both PFS and OS across ethnic groups is a promising assessment for the current landscape of health disparities in mRCC. As these data are distinct from recent findings identifying disparities in other malignancies (e.g., prostate cancer), multicenter collaborations should be encouraged to validate these findings.

699 Nivolumab in metastatic nonclear cell renal cell carcinoma: First results of the AcSe prospective study. L Albiges, D Pouessel, M Beylot-Barry, et al

Conclusions:We report the first prospective study of N single agent in non-clear cell RCC. N demonstrates limited activity in a pretreated and heterogeneous non- clear cell RCC population. Interestingly 1/4 CDC developed PR while no response was noted in chromophobe RCC. Clinical trial information: NCT03012581

721 Clinical correlation of circulating tumor cell (CTC) PD-L1 and HLA I expression in metastatic renal cell carcinoma (mRCC) using exclusion-based sample preparation technology. H Emamekhoo, JL Schehr, RM Bade, et al

Conclusions:Assessment of CTC heterogeneity may provide valuable molecular insights and diversify tools for early detection of therapeutic response and resistance that may guide treatment decision making. This assay is being tested in ongoing Phase II clinical trials.

731 Longitudinal multiplex cytokine analysis for patients (pts) with metastatic renal cell carcinoma (mRCC) treated with ipilimumab/nivolumab (I+N). T Zhang, Y Wu, A Agarwal, et al

Conclusions:In this pilot exploratory analysis, a subset of ILs are higher at baseline in DC than PD pts. A wk-4 increase in circulating IFN-g is associated with DC vs PD and could be linked to increased early inflammation and response to I+N. Larger prospective studies are needed to validate these findings.

Saturday, February 15, 2020; 7:00 AM–7:55 AM
Trials in Progress Poster Session C: Renal Cell Cancer

TPS760 PDIGREE: An adaptive phase III trial of PD-inhibitor nivolumab and ipilimumab (IPI-NIVO) with VEGF TKI cabozantinib (CABO) in metastatic untreated renal cell cancer (Alliance A031704). T Zhang, KV Ballman, AD Choudhury, et al

Clinical trial information: NCT03793166

TPS764 A phase I trial to assess the biologic effect of CBM588 (Clostridium butyricum) in combination with nivolumab plus ipilimumab (nivo/ipi) in patients with metastatic renal cell carcinoma (mRCC). PG Bergerot, N Dizman, N Ruel, et al

Clinical trial information: NCT03829111

TPS767 A phase III study (COSMIC-313) of cabozantinib (C) in combination with nivolumab (N) and ipilimumab (I) in patients (pts) with previously untreated advanced renal cell carcinoma (aRCC) of intermediate or poor risk. TK Choueiri, L Albiges, T Powles, et al

Clinical trial information: NCT03937219

Saturday, February 15, 2020; 7:55 AM–9:30 AM
Oral Abstract Session C: Renal Cell Cancer 

611 Phase I/II study of the oral HIF-2 α inhibitor MK-6482 in patients with advanced clear cell renal cell carcinoma (RCC). TK Choueiri, ER Plimack, TM Bauer, et al

Conclusions:MK-6482 is well tolerated with a favorable safety profile and demonstrated promising single-agent activity in heavily pretreated pts with ccRCC across IMDC risk groups. A phase 3 trial in a similar population is planned. Clinical trial information: NCT02974738

612 A phase I/II trial of sitravatinib (sitra) combined with nivolumab (nivo) in patients (pts) with advanced clear cell renal cell cancer (aCCRCC) that progressed on prior VEGF-targeted therapy. P Msaouel, PF Thall, Y Yuan, et al

Conclusions:The combination of sitra + nivo has not demonstrated unexpected safety signals and produces higher objective responses and longer disease control compared with what is historically expected with nivo alone in pts with aCCRCC that progressed on prior VEGF-targeted therapy. Clinical trial information: NCT03015740

614 Combination of dual immune checkpoint inhibition (ICI) with stereotactic radiation (SBRT) in metastatic renal cell carcinoma (mRCC) (RADVAX RCC). HJ Hammers, D Vonmerveldt, C Ahn, et al

Saturday, February 15, 2020; 10:00 AM–11:30 AM

General Session: How to Optimize First-Line Systemic Therapy Selection in the Treatment of Renal Cell Carcinoma

609 Overall survival and independent review of response in CheckMate 214 with 42-month follow-up: First-line nivolumab + ipilimumab (N+I) versus sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC). NM Tannir, DF McDermott, B Escudier, et al

Conclusions:Superior OS and ORR with N+I v S was maintained in ITT and IP pts. More pts treated with N+I experienced CR compared with S, responses and CRs were durable, and PFS probabilities stabilized with N+I after extended follow-up. No new safety signals emerged. Clinical trial information: NCT02231749.

Saturday, February 15, 2020; 11:35 AM–12:30 PM
Rapid Abstract Session C: Renal Cell Cancer

616 Prevalence and landscape of actionable genomic alterations in renal cell carcinoma. K Attalla, RG DiNatale, E Reznik, et al

Conclusions:Although the prevalence of actionable mutations in RCC seems to have doubled in recent years, the role of genetic testing in identifying candidates for targeted therapy in RCC is currently limited relative to other cancer types, emphasizing the need for additional research in this area to further inform targeted therapy decisions.

Aanbevolen abstracten door Eric Jonasch MD

Session: Genitourinary Cancer—Kidney and Bladder

5001 Pembrolizumab plus axitinib versus sunitinib as first-line therapy for advanced renal cell carcinoma (RCC): Updated analysis of KEYNOTE-426. ER Plimack, BI Rini, V Stus, et al

Take-Home Message

  • This is a follow-up of the Keynote-426 study.
  • The superiority of axitinib plus pembrolizumab over sunitinib was maintained, with an ORR of 60% versus 40% and a CR rate of 9% versus 3% for axitinib plus pembrolizumab versus sunitinib, showing that this remains a preferred regimen for patients with advanced sporadic RCC.

5002 SAVOIR: A phase III study of savolitinib versus sunitinib in pts with MET-driven papillary renal cell carcinoma (PRCC). TK Choueiri, DYC Heng, J-L Lee, et al

5003 Phase II study of the oral HIF-2α inhibitor MK-6482 for Von Hippel-Lindau disease–associated renal cell carcinoma. E Jonasch, F Donskov, O Iliopoulos, et al

Take-Home Message

  • This phase II 61-patient study testing the HIF-2α inhibitor MK6482 in patients with von Hippel-Lindau disease–related RCC showed a confirmed ORR of 27.9% with an additional 13% unconfirmed PR in renal lesions, along with good tolerability. Response was also seen in non-RCC lesions.
  • These data strongly support the use of MK6482 in patients with VHL disease.

5004 Results from a phase II study of bevacizumab and erlotinib in subjects with advanced hereditary leiomyomatosis and renal cell cancer (HLRCC) or sporadic papillary renal cell cancer. R Srinivasan, S Gurram, M Al Harthy, et al

Take-Home Message

  • This phase II 83-patient study tested the combination of erlotinib plus bevacizumab in patients with papillary RCC. The participants were split between individuals with hereditary leiomyomatosis and renal cell cancer (HLRCC) and those with sporadic disease.
  • With an ORR of 64% in the HLRCC cohort and 37% in the sporadic cohort, a median progression-free survival of 21.1 months in the HLRCC cohort and 8.7 months in the sporadic cohort, these are groundbreaking data for patients with HL-related RCC.

5005 Optimized management of nivolumab (Nivo) and ipilimumab (Ipi) in advanced renal cell carcinoma (RCC): A response-based phase II study (OMNIVORE). RR McKay, W Xie, BA McGregor, et al

Take-Home Message

  • The OMNIVORE study tested whether initial treatment of metastatic RCC patients with nivolumab monotherapy followed by the addition of up to two cycles of ipilimumab in nonresponders (either stable or progressive disease) would provide similar efficacy to upfront combination therapy with less toxicity.
  • In this 83-patient study, upfront nivolumab monotherapy resulted in a PR in 11% of patients, and adding ipilimumab only converted a further 4% to a PR, suggesting that delaying treatment with ipilimumab decreased the overall efficacy of the nivolumab plus ipilimumab combination.

5006 Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced renal cell carcinoma (RCC) (HCRN GU16-260). MB Atkins, O Jegede, NB Haas, et al

Take-Home Message

  • Similar to 5005 above, this study treated 123 metastatic RCC patients with upfront nivolumab and added up to four doses of ipilimumab in patients with stable or progressive disease. The initial ORR was 29.3%, with a 4.3% CR rate, and 30.7% of patients had progressive disease as best response. Best response to nivolumab/ ipilimumab was 11%, and progressive disease occurred in 59% of patients.
  • This study provided further evidence that delayed ipilimumab may be inferior to upfront combination therapy.

5007 FRACTION-RCC: Innovative, high-throughput assessment of nivolumab + ipilimumab for treatment-refractory advanced renal cell carcinoma (aRCC). TK Choueiri, HM Kluger, S George, et al

Take-Home Message

  • The open-label, randomized, phase II Fast Real-time Assessment of Combination Therapies in Immuno-ONcology (FRACTION-RCC) study enrolled 46 patients with previously treated, PD-1–refractory RCC onto the ipilimumab/ nivolumab arm. The objective response rate was 15.2%; no patients achieved complete response, and 7 achieved partial response.
  • Once again, the combination of ipilimumab plus nivolumab underperformed as a subsequent-line therapy.

5008 Phase II trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) for disease progression after PD-1/PD-L1 immune checkpoint inhibitor (ICI) in metastatic clear cell renal cell carcinoma (mccRCC). C-H Lee, AY Shah, JJ Hsieh, et al

Take-Home Message

  • In this 104-patient, phase II study, metastatic RCC patients who were refractory to PD-1 therapy were treated with the combination of lenvatinib and pembrolizumab. The ORR was 51%, progression-free survival was 11.7 months, and median duration of response was 9.9 months.
  • These are some of the strongest data we have seen to date in the immune-oncology–refractory population, and they support further development of this combination as a later-line therapy in advanced RCC.

Aanbevolen door Prof. Dr. Tom Guzzo

Kidney Cancer

5065.134 A phase II multicenter study of stereotactic radiotherapy (SRT) for oligoprogression in metastatic renal cell cancer (mRCC) patients receiving tyrosine kinase inhibitor (TKI) therapy. P Cheung, S Patel, SA North, et al

Take-Home Message

  • Patients with metastatic renal cell cancer (mRCC) with oligoprogression on tyrosine kinase inhibitor (TKI) therapy were treated with stereotactic radiotherapy (SRT) for oligoprogressive tumors. The median progression-free survival was 9.6 months, and most progression occurred outside the irradiated areas. The local control rate of irradiated tumors at 2 years was 96%. The median time to change in systemic therapy was 12.6 months.
  • SRT for oligoprogressive mRCC tumors resulted in high control rates, and patients did not need to change systemic therapy for a year, hence improving the outcomes associated with TKI therapy.

5066.135 Clinically advanced renal cell carcinoma (RCC) and renal sarcoma (RSC) in young patients: A comprehensive genomic profiling (CGP) study. G Bratslavsky, A Necchi, P Grivas, et al

Take-Home Message

  • Tumor samples from patients with advanced renal cell carcinoma (RCC) and renal sarcoma (RSC) underwent comprehensive genomic profiling to compare genetic alterations (GAs) in patients aged <40 years and those aged ≥40 years. The male preponderance increased in patients aged ≥40 years. There was an increase in GAs in the older group compared with the younger group for all tumor subtypes except medullary RCC, and the tumor mutational burden (TMB) was higher in older versus younger patients. There were significant differences in GAs seen between the two age groups.
  • Compared with younger patients, patients aged ≥40 years with RCC and RSC have a higher rate of GAs, a higher TMB, and a greater male preponderance. These data can inform future trials of personalized treatment for this population.

E17072 Survival outcomes of metastatic renal cell carcinoma (RCC) patients with pancreatic metastases (PM): Pooled analysis from a large clinical trials database. J Shaya, X Lin, A Cabal, et al

Take-Home Message

  • The authors of this pooled analysis evaluated overall survival in patients with metastatic renal cell carcinoma (RCC) with and without pancreatic metastases (PM). The median overall survival was 41.7 months in patients with PM versus 19.0 months in those without PM. In patients with PM, overall survival was longest in patients with favorable or intermediate IMDC risk, treatment-naïve patients, and patients treated with VEGF inhibitors or cytokine therapy. Progression-free survival and objective response rates were significantly greater in those with PM compared with those without PM.
  • The presence of PM in patients with advanced RCC is a good prognostic indicator, especially in patients treated with VEGF inhibitors and IMDC-favorable and intermediate-risk disease. Therapy for patients with RCC and PM should be personalized given this favorable prognosis.

E17080 The role of cytoreductive nephrectomy in metastatic renal cell carcinoma. YM Alnimer, A Qasrawi, K Katato, et al

Take-Home Message

  • Data from the SEER registry from 2010 to 2016 were analyzed to evaluate the survival benefit of cytoreductive nephrectomy (CN) in patients with metastatic renal cell carcinoma. The risk of death was significantly lower in patients with CN compared with patients not treated with CN for both clear cell and non–clear cell histology. Factors associated with a higher risk of death included number of metastatic sites, higher tumor grade, female gender, increasing age, and not receiving chemotherapy.
  • CN was associated with a survival benefit among patients with metastatic renal cell carcinoma, although there is the potential for selection bias in this study. CN should be considered for all patients with metastatic renal cell carcinoma until further data are available.

TPS5101.170 PROSPER: Phase III randomized study comparing perioperative nivolumab versus observation in patients with renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN EA8143). NB Haas, M Puligandla, ME Allaf, et al

Take-Home Message

  • Patients with high-risk renal cell carcinoma planned for radical or partial nephrectomy are being enrolled in this randomized phase III trial to compare overall survival following neoadjuvant nivolumab plus surgery or surgery with standard-of-care surveillance.

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