Axitinib

(Inlyta®)

Inlyta®

Drug updated on 11/1/2024

Dosage FormTablet (oral; 1 mg, 5 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC)
  • Indicated in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC
  • Indicated as a single agent, for the treatment of advanced RCC after failure of one prior systemic therapy.

Latest News

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Summary
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  • This summary is based on the review of 32 systematic review(s)/meta-analysis(es). [1-32]
  • Axitinib Monotherapy in Advanced RCC (renal cell carcinoma) After Prior Therapy: Median progression-free survival (PFS) ranged between 5.5 and 8.7 months, with median overall survival (OS) ranging from 11.0 to 69.5 months.
  • Combination Therapy Effectiveness: Pembrolizumab plus Axitinib achieved the highest PFS and OS rates in several studies, while Nivolumab plus Cabozantinib and Pembrolizumab plus Lenvatinib showed significant PFS improvements. Nivolumab plus Ipilimumab was effective for intermediate and poor-risk groups, and Avelumab plus Axitinib was beneficial for PFS and objective response rate (ORR) in favorable-risk patients.
  • Comparative Efficacy Among Combinations: Pembrolizumab plus Axitinib demonstrated superior OS and PFS over Sunitinib, while outperforming Axitinib plus Avelumab in OS and PFS outcomes. Axitinib-based combinations generally improved outcomes compared to Sunitinib monotherapy.
  • Network Meta-Analysis Findings: Pembrolizumab plus Axitinib ranked highest for OS and PFS across studies, with Pembrolizumab plus Lenvatinib also ranking highly for OS and PFS. Nivolumab plus Ipilimumab showed favorable OS specifically in intermediate and poor-risk groups.
  • Common adverse effects of Axitinib included hypertension, hand-foot syndrome, and fatigue, with a notably higher incidence of both all-grade and grade ≥3 hypertension compared to placebo, while thromboembolism (DVT/PE) and hypothyroidism risks were not increased.
  • Combination therapy of Pembrolizumab plus Axitinib showed higher incidences of grade ≥3 adverse events than Sunitinib, whereas Nivolumab plus Ipilimumab exhibited lower rates of grade ≥3 adverse events.
  • Pembrolizumab plus Lenvatinib was associated with a higher incidence of serious adverse events, and although Nivolumab plus Ipilimumab had lower grade ≥3 adverse events, it led to higher rates of treatment discontinuation due to adverse effects.
  • Elderly patients (>65 years) demonstrated improved overall survival (OS) with Pembrolizumab plus Axitinib; favorable-risk patients benefited from Avelumab plus Axitinib for progression-free survival (PFS); intermediate and poor-risk groups saw higher efficacy with Pembrolizumab plus Axitinib and Nivolumab plus Ipilimumab, while efficacy and safety were consistent across genders, and patients with cardiovascular comorbidities required monitoring due to high-grade hypertension risks with Axitinib.

Product Monograph / Prescribing Information

Document TitleYearSource
Inlyta (axitinib) Prescribing Information.2024Pfizer Inc., New York, NY

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Axitinib after Treatment Failure with Sunitinib or Cytokines in Advanced Renal Cell Carcinoma-Systematic Literature Review of Clinical and Real-World Evidence2024Cancers
Systemic hypertension with VEGFR inhibitor (axitinib) therapy in cancer patients: A meta-analysis and systematic review of randomized controlled trials2024International Journal of Cardiology. Heart & Vasculature
Efficacy and toxicity of immune checkpoint inhibitors combination therapy for advanced renal cell carcinoma: a systematic review and network meta-analysis2024Frontiers in Immunology
Comparative safety of tyrosine kinase inhibitors in the treatment of metastatic renal cell carcinoma: a systematic review and network meta-analysis2023Frontiers in Pharmacology
A systematic review to summarize treatment patterns, guidelines, and characteristics of patients with renal cell carcinoma in the Asia-Pacific region2023Expert Review of Anticancer Therapy
First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis2023The Cochrane Database of Systematic Reviews
Efficacy and Safety of Checkpoint Inhibitors in Clear Cell Renal Cell Carcinoma: A Systematic Review of Clinical Trials2023Hematology/Oncology and Stem Cell Therapy
Comparing efficacy and safety of first-line treatment of metastatic renal cell carcinoma: A Bayesian network meta-regression analysis2023Frontiers in Oncology
First-line therapy for elderly patients with advanced renal cell carcinoma in the immuno-oncology era: a network meta-analysis2023Cancer Immunology, Immunotherapy
Optimizing targeted drug selection in combination therapy for patients with advanced or metastatic renal cell carcinoma: A systematic review and network meta-analysis of safety2023Cancer medicine
Evolving landscape of first-line combination therapy in advanced renal cancer: a systematic review2022Therapeutic Advances in Medical Oncology
Pembrolizumab in advanced renal cell carcinoma: a meta-analysis providing level 1a evidence2022Current Problems in Cancer
Systemic therapy in metastatic renal cell carcinoma (mRCC): an evidence-based recommendation of the German interdisciplinary RCC guidelines group2022World Journal of Urology
Efficacy and Safety of First-line Systemic Therapy for Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-analysis2022European Urology Open Science
Clinical Outcomes and Adverse Events after First-Line Treatment in Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-Analysis2022The Journal of Urology
Impact of Clinicopathological Features on Survival in Patients Treated with First-line Immune Checkpoint Inhibitors Plus Tyrosine Kinase Inhibitors for Renal Cell Carcinoma: A Meta-analysis of Randomized Clinical Trials2022European Urology Focus
A Living, Interactive Systematic Review and Network Meta-analysis of First-line Treatment of Metastatic Renal Cell Carcinoma2021European Urology
Comparative efficacy and safety of immunotherapy in the first-line treatment of metastatic renal cell carcinoma: a systematic review and network meta-analysis2021Annals of Palliative Medicine
A network meta-analysis of efficacy and safety of first-line and second-line therapies for the management of metastatic renal cell carcinoma2021Journal of Clinical Pharmacy and Therapeutics
Systemic therapy for metastatic renal cell carcinoma in the first-line setting: a systematic review and network meta-analysis2021Cancer Immunology, Immunotherapy
Targeted therapy for metastatic renal cell carcinoma2020The Cochrane Database of Systematic Reviews
First-line treatments for advanced renal-cell carcinoma with immune checkpoint inhibitors: systematic review, network meta-analysis and cost-effectiveness analysis2020Therapeutic Advances in Medical Oncology
The clinical significance of routine risk categorization in metastatic renal cell carcinoma and its impact on treatment decision-making: a systematic review2020Future Oncology
What is the optimum systemic treatment for advanced/metastatic renal cell carcinoma of favourable, intermediate and poor risk, respectively? A systematic review and network meta-analysis2020BMJ Open
Safety evaluation of immune-based combinations in patients with advanced renal cell carcinoma: a systematic review and meta-analysis2020Expert Opinion on Drug Safety
Comparative Efficacy of First-Line Immune-Based Combination Therapies in Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-Analysis2020Cancers
Targeted and immune therapies among patients with metastatic renal carcinoma undergoing hemodialysis: A systemic review2020Seminars in oncology
First-line Treatment of Metastatic Renal Cell Carcinoma in the Immuno-oncology Era: Systematic Review and Network Meta-analysis2020Clinical Genitourinary Cancer
Combination Therapy for Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-analysis2020American Journal of Clinical Oncology
Incidence and risk of proteinuria associated with newly approved vascular endothelial growth factor receptor tyrosine kinase inhibitors in cancer patients: an up-to-date meta-analysis of randomized controlled trials2020Expert review of clinical pharmacology
A Systematic Review of Systemic Treatment Options for Advanced Non-Clear Cell Renal Cell Carcinoma2020Kidney Cancer
First-line Treatment of Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-analysis2019European Urology Oncology

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