JAVELIN renal 101: A randomized, phase III study of avelumab + axitinib vs sunitinib as first-line treatment of advanced renal cell carcinoma (aRCC)

Motzer, Robert J.; Penkov, Konstantin; Haanen, John B.A.G.; Rini, Brian I.; Albigès, Laurence; Campbell, Matthew T.; Kollmannsberger, Christian; Négrier, Sylvie; Uemura, Mamoru; Lee, J.L.; Berger, Raanan; Schmidinger, Manuela; Larkin, James; Atkins, Michael B.; Wang, J.; Robbins, Paul B.; Chudnovsky, A.; Pietro, Alessandra di; Choueiri, Toni K.

doi:10.1093/annonc/mdy424.036

Cited by 40 publications

(38 citation statements)

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“…Axitinib has also been evaluated in combination with avelumab in the JAVELIN renal 100 trial, with manageable toxicity and encouraging antitumor activity in preliminary analysis [25]. The combination significantly improved PFS in patients with PD-L1+ expression, with PFS and ORR benefits also observed in patients irrespective of PD-L1 expression and across all prognostic risk groups [26].…”

Section: Immunotherapy In Gu: What's New?mentioning

confidence: 99%

Perspectives in immunotherapy: meeting report from the “Immunotherapy Bridge 2018” (28–29 November, 2018, Naples, Italy)

Ascierto

Buonaguro

Emens

et al. 2019

j. immunotherapy cancer

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Immunotherapy is now widely established as a potent and effective treatment option across several types of cancer. However, there is increasing recognition that not all patients respond to immunotherapy, focusing attention on the immune contexture of the tumor microenvironment (TME), drivers of the immune response and mechanisms of tumor resistance to immunity. The development of novel immunotherapeutics and their use in combination with checkpoint inhibitors and other standard of care and novel treatment modalities is an area of particular attention across several tumor types, including melanoma, lung, ovarian, breast, pancreatic, renal, head and neck, brain and non-melanoma skin cancers. The 4th Immunotherapy Bridge meeting (28-29 November, 2018, Naples, Italy) focused on a wide range of evolving topics and trends in the field of cancer immunotherapy and key presentations from this meeting are summarised in this report.

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Section: Immunotherapy In Gu: What's New?mentioning

confidence: 99%

Perspectives in immunotherapy: meeting report from the “Immunotherapy Bridge 2018” (28–29 November, 2018, Naples, Italy)

Ascierto

Buonaguro

Emens

et al. 2019

j. immunotherapy cancer

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“…This open-label, multicenter dose-finding trial showed objective responses in 6 out of 6 patients (100%, 95% CI: 54-100) in the initial dose-finding cohort and 26 out of 49 patients (53%, 38-68) in the dose-expansion cohort. These results paved the way for the phase III trial, Javelin 101, comparing avelumab plus axitinib vs. sunitinib in 886 patients with treatment-naïve, advanced RCC, with updated data recently presented at the European Society of Medical Oncology (ESMO) 2018 conference [41]. Patients were stratified by PD-L1 expression, with 560 patients of the 886 randomized patients in the PD-L1+ group, and randomized in 1:1 fashion to receive either avelumab 10 mg/kg IV every 2 weeks plus axitinib 5 mg orally twice daily for a 6-week cycle or sunitinib 50 mg orally daily for 4 weeks on, followed by 2 weeks off.…”

Section: B Javelin Renal 101: Avelumab + Axitinib Vs Sunitinibmentioning

confidence: 97%

The Emerging Role of Combination Angiogenesis Inhibitors and Immune Checkpoint Inhibitors in the Treatment of Metastatic Renal Cell Cancer

Nizam

Rhea

Gupta

et al. 2019

KCA

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The advent of vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKIs) a decade ago revolutionized the treatment paradigm in advanced metastatic clear cell renal cell carcinoma (RCC) with improved survival rates compared to the pre-TKI era. Monotherapy with VEGF TKIs has remained first-line. However, sequencing of different TKIs, mammalian target of rapamycin (mTOR) inhibitors, or immune checkpoint inhibitors (ICIs) has been the subject of controversy in the treatment landscape of metastatic RCC. First-line treatment further evolved with the approval of nivolumab plus ipilimumab in intermediate-and poor-risk patients based on an overall survival (OS) benefit demonstrated in the CheckMate214 trial as well as a progression-free survival (PFS) benefit of cabozantinib in the CABOSUN trial. Optimal sequencing, patient selection, and understanding resistance pathways continue to be prominent concerns. Efforts to bypass resistance mechanisms have led to the study of combination therapies. Given enhancement of immune checkpoint inhibitor (ICI) T-cell mediated effects by VEGF-mediated immunosuppression, the combination of VEGF inhibitors and ICIs in treatment-naïve locally advanced and metastatic RCC has shown promise. Available results of phase III trials utilizing these combinations are discussed herein.

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“…Overcoming primary resistance to CPI therapy can be achieved by the combination with targeted therapy. Axitinib plus the PD(L)-1 inhibitor avelumab (or pembrolizumab) is superior to sunitinib monotherapy in advanced renal cell carcinoma (PFS 13.8 vs 8.4 months; HR 0.69) [19]. Although the tolerability of this combination was similar between the groups, it has to be noted that the combination of a CPI with targeted agent can lead to major toxicity as well.…”

Section: Clinical Datamentioning

confidence: 99%

Resistance to immune checkpoint inhibitors. Next steps and combinational approaches

Fuereder

2019

memo

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Immuno-oncology and in particular checkpoint inhibitor (CPI) treatment has become a novel promising cancer therapy strategy in recent years. However, still a minority of patients respond to checkpoint blockade. Primary and secondary resistance to CPI is a challenge in the daily clinical routine. Combination strategies have been tested in various clinical trials in order to address this issue. Data available from these trials indicate improved activity depending on the tumor type. This review article focuses on the molecular background for resistance to CPI, gives an overview of current clinical data of CPI combination studies and points out potential strategies to overcome CPI resistance depending on the immune phenotype.

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JAVELIN renal 101: A randomized, phase III study of avelumab + axitinib vs sunitinib as first-line treatment of advanced renal cell carcinoma (aRCC)

Cited by 40 publications

References 0 publications

Perspectives in immunotherapy: meeting report from the “Immunotherapy Bridge 2018” (28–29 November, 2018, Naples, Italy)

Perspectives in immunotherapy: meeting report from the “Immunotherapy Bridge 2018” (28–29 November, 2018, Naples, Italy)

The Emerging Role of Combination Angiogenesis Inhibitors and Immune Checkpoint Inhibitors in the Treatment of Metastatic Renal Cell Cancer

Resistance to immune checkpoint inhibitors. Next steps and combinational approaches

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