Efficacy and safety of avelumab plus axitinib in elderly patients with advanced renal cell carcinoma: extended follow-up results from JAVELIN Renal 101

Tomita, Yoshihiko; Motzer, Robert J.; Choueiri, Toni K.; Rini, Brian I.; Uemura, Hirotsugu; Albigès, Laurence; Fujii, Yukihiko; Umeyama, Yoshiko; Wang, J; Mariani, Mariangela; Schmidinger, Manuela

doi:10.1016/j.esmoop.2022.100450

Cited by 21 publications

(18 citation statements)

References 23 publications

(61 reference statements)

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“…19 In a subgroup analysis of J-DART reported here, median PFS with avelumab plus axitinib in patients aged ≥75 years or <75 years was 12.0 months (95% CI, 4.1 months-NE) and 15.3 months (95% CI, 9.7 months-NE), respectively, consistent with findings from the subgroup analysis of JAVELIN Renal 101. 19 In the present study, half of patients were still receiving first-line avelumab plus axitinib therapy at the end of the observational period. Median durations of avelumab and axitinib therapy in J-DART (6.9 and 5.9 months, respectively) were similar to those in JAVELIN Renal 101 in the overall population (8.6 and 9.0 months, respectively) 7 and the Japanese subgroup (7.8 and 8.7 months, respectively).…”

Section: Discussionsupporting

confidence: 85%

“…In the JAVELIN Renal 101 trial, however, avelumab plus axitinib showed favorable efficacy compared with sunitinib and consistent tolerability across age groups, including patients aged ≥75 years 19 . In a subgroup analysis of J‐DART reported here, median PFS with avelumab plus axitinib in patients aged ≥75 years or <75 years was 12.0 months (95% CI, 4.1 months–NE) and 15.3 months (95% CI, 9.7 months–NE), respectively, consistent with findings from the subgroup analysis of JAVELIN Renal 101 19 …”

Section: Discussionmentioning

confidence: 98%

“…To date, it has been hypothesized that immunotherapy may be less effective in older patients than in younger patients because of immune senescence 17,18 . In the JAVELIN Renal 101 trial, however, avelumab plus axitinib showed favorable efficacy compared with sunitinib and consistent tolerability across age groups, including patients aged ≥75 years 19 . In a subgroup analysis of J‐DART reported here, median PFS with avelumab plus axitinib in patients aged ≥75 years or <75 years was 12.0 months (95% CI, 4.1 months–NE) and 15.3 months (95% CI, 9.7 months–NE), respectively, consistent with findings from the subgroup analysis of JAVELIN Renal 101 19 …”

Section: Discussionmentioning

confidence: 99%

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Real‐world outcomes of avelumab plus axitinib as first‐line therapy in patients with advanced renal cell carcinoma in Japan: A multicenter, retrospective, observational study (J‐DART)

Kato,

Nakano,

Hongo

et al. 2023

Int J of Urology

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ObjectivesIn the phase 3 JAVELIN Renal 101 trial in patients with advanced renal cell carcinoma (aRCC), objective response rate (ORR) and progression‐free survival (PFS) were significantly improved in patients treated with first‐line avelumab plus axitinib vs sunitinib. Here we evaluate real‐world outcomes with first‐line avelumab plus axitinib in Japanese patients with aRCC.MethodsIn this multicenter, noninterventional, retrospective study, clinical data from patients with aRCC treated with first‐line avelumab plus axitinib between December 2019 and December 2020 in Japan were reviewed. Endpoints included ORR and PFS per investigator assessment, and time to treatment discontinuation (TTD).ResultsData from 48 patients (median age, 69 years) from 12 sites were analyzed. Median follow‐up was 10.4 months (range, 2.6–16.5), and median duration of treatment was 7.4 months (range, 0.5–16.5). International Metastatic RCC Database Consortium risk category was favorable, intermediate, or poor in 16.7%, 54.2%, and 29.2% of patients, respectively. The ORR was 48.8% (95% CI, 33.3%–64.5%), including complete response in 3/43 patients (7.0%). Thirteen patients (27.1%) had disease progression or died, and median PFS was 15.3 months (95% CI, 9.7 months – not estimable). At data cutoff, 24 patients (50.0%) were still receiving avelumab plus axitinib, and median TTD was 15.2 months (95% CI, 7.4 months – not estimable). Three patients (6.3%) received high‐dose corticosteroid treatment for immune‐related adverse events, and 8 (16.7%) received treatment for infusion‐related reactions.ConclusionsWe report the first real‐world evidence of the effectiveness and tolerability of first‐line avelumab plus axitinib in Japanese patients with aRCC. Results were comparable with the JAVELIN Renal 101 trial.

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Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

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Real‐world outcomes of avelumab plus axitinib as first‐line therapy in patients with advanced renal cell carcinoma in Japan: A multicenter, retrospective, observational study (J‐DART)

Kato,

Nakano,

Hongo

et al. 2023

Int J of Urology

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“…Treating tRCC with avelumab–axitinib can be long term because AEs are easily controlled. The rate of severe adverse effects in phase III trials was higher for IO–TKI therapy 3–6 than IO–IO 7 . This is probably due to most AEs of IO–TKI therapy being similar to TKI profiles.…”

Section: Discussionmentioning

confidence: 97%

“…The standard first‐line treatment recommended for advanced RCC is IO combination therapy 2–7 . The efficacy of IO or tyrosine kinase inhibitor (TKI) monotherapy for tRCC has been indicated 8–11 .…”

Section: Discussionmentioning

confidence: 99%

Avelumab plus axitinib for translocation renal cell carcinoma: A case series and literature review

Takahashi,

Kato,

Ikarashi

et al. 2023

IJU Case Reports

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IntroductionPatients with translocation renal cell carcinoma (tRCC) have a poor prognosis without standardized treatment.Case presentationThe first case was of a 72‐year‐old woman who underwent robot‐assisted partial nephrectomy for a left renal tumor and was pathologically diagnosed with tRCC. Recurrence was observed in the left retroperitoneal soft tissue. After treatment with avelumab–axitinib, continued progression‐free survival was confirmed at the 90‐week follow‐up. The second case was of a 41‐year‐old woman referred to our hospital and presented with translocation renal cell carcinoma metastasis to a para‐aortic lymph node. After treatment with avelumab–axitinib, continued progression‐free survival was confirmed at the 43‐week follow‐up.ConclusionThe outcomes of these cases indicate that avelumab–axitinib therapy has a long‐term antitumor effect in some patients with tRCC.

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First-line therapy for elderly patients with advanced renal cell carcinoma in the immuno-oncology era: a network meta-analysis

Fujiwara

Miyashita

Liaw

2022

Cancer Immunol Immunother

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Efficacy and safety of avelumab plus axitinib in elderly patients with advanced renal cell carcinoma: extended follow-up results from JAVELIN Renal 101

Cited by 21 publications

References 23 publications

Real‐world outcomes of avelumab plus axitinib as first‐line therapy in patients with advanced renal cell carcinoma in Japan: A multicenter, retrospective, observational study (J‐DART)

Real‐world outcomes of avelumab plus axitinib as first‐line therapy in patients with advanced renal cell carcinoma in Japan: A multicenter, retrospective, observational study (J‐DART)

Avelumab plus axitinib for translocation renal cell carcinoma: A case series and literature review

First-line therapy for elderly patients with advanced renal cell carcinoma in the immuno-oncology era: a network meta-analysis

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