This site contains promotional information intended only for healthcare professionals resident in the United Kingdom
Menu
Close
Example of description text sitting alongside header
Example of description text sitting alongside header
Menu
Close
Example of description text sitting alongside header
Example of description text sitting alongside header
Menu
Close
Adverse event reporting can be found at the bottom of the page
Menu
Close
The content of this website has been produced in line with the INLYTA® (axitinib) Summary of Product Characteristics for Great Britain.
Prescribing Information for INLYTA® (axitinib) click here. Prescribing Information for SUTENT® (sunitinib malate) click here. Adverse event reporting information can be found at the bottom of the page.
A video featuring Prof Brian Rini, Professor of Medicine and Chief of Clinical Trials at Vanderbilt-Ingram Cancer Center on the treatment landscape of aRCC, the sequencing of treatment, the role of Inlyta® (axitinib) in second-line aRCC and AXIS trial data.
AXIS trial study design
AXIS trial primary endpoints
AXIS trial secondary endpoints
AXIS trial1,4
A randomised, multicentre, Phase III open-label trial of 723 patients with aRCC with disease progression on first-line therapy (sunitinib or cytokine), comparing the efficacy and tolerability of INLYTA® 5 mg twice daily and sorafenib 400 mg twice daily4
AXIS trial design
AXIS was a randomised, multicentre, Phase III open-label trial comparing INLYTA® 5 mg twice daily and sorafenib 400 mg twice daily in patients with aRCC with disease progression on first-line therapy (sunitinib or cytokine)4
*≥4 weeks for bevacizumab plus interferon-alfa. †Patients who tolerated the starting dose with no adverse reactions above grade 2 of CTCAE for ≥2 weeks were allowed to have their dose increased to 7mg twice daily, up to a maximum of 10 mg twice daily, unless the patient’s blood pressure was higher than 150/90 mmHg or the patient was receiving anti hypertensive medication. The INLYTA® dose could be reduced to 3 mg twice daily and then further to 2 mg twice daily, if needed. ‡Dose could be decreased to 400 mg once daily, and then to 400 mg every other day if dose reduction was needed because of toxic effects. §Defined as time from randomisation to either first documentation of RECIST defined disease progression (per independent radiology review of images) or death due to any cause, whichever came first. ¶ A composite endpoint consisting of time to death, disease progression, or worsening of symptoms. Symptom deterioration was defined as two consecutive available decreases of at least 5 points from baseline using FKSI-15 (≥3 points using FKSI-DRS), unless it was the final score, for which one decrease was sufficient. Adapted from Rini BI et al. 2011.4
INLYTA® significantly prolonged mPFS vs. sorafenib in patients with advanced RCC in the overall population1
Figure adapted from INLYTA® Summary of Product Characteristics.1
Time from randomisation to progression or death due to any cause, whichever occurs first. Cut-off date: 03 June 2011.1
As of 1 November, 2011, INLYTA® sustained an improvement in mPFS vs. sorafenib in patients with advanced RCC in the overall population8
Adapted from Motzer J et al. 2013.8
As of Nov 1, 2011, median duration of treatment was 8.2 months (range <0.1–33.4) with INLYTA® and 5.2 months (0.2–34.1) with sorafenib.8
INLYTA® demonstrated similar mOS vs. sorafenib as second-line therapy for advanced RCC in the overall population*†8
Figure adapted from Motzer J et al. 2013.8
*Median OS for overall population was 20.1 months with INLYTA® and 19.2 months with sorafenib.8
†As of Nov 1, 2011, median duration of treatment was 8.2 months (range <0.1–33.4) with INLYTA® and 5.2 months (0.2–34.1) with sorafenib.8
INLYTA® demonstrated similar mOS vs. sorafenib as second-line therapy for advanced RCC in patients previously treated with sunitinib*†1
Figure adapted from Motzer J et al. 2013.8
*Median OS for prior sunitinib therapy subgroup population was 15.2 months with INLYTA® and16.5 months with sorafenib.1
†As of Nov 1, 2011, median duration of treatment was 8.2 months (range <0.1–33.4) with INLYTA® and 5.2 months (0.2–34.1) with sorafenib.1
AXIS trial safety data
Most common AEs (≥20% reported in RCC studies in patients who received INLYTA® (N=672)1
Please refer to the INLYTA® SmPC for full safety profile information and guidance on the management of TRAEs.1
In the Phase III AXIS trial, only 4% of patients discontinued treatment with INLYTA® due to TRAEs vs. 8% of patients treated with sorafenib*4
Adapted from Rini BI et al. 2011.4
*As of the data cut-off date of Aug 31, 2010, patients had received INLYTA® for a median duration of 6·4 months (range 0·03–22), and sorafenib for 5·0 months (range 0·03–20).4
AXIS trial subgroup analyses
INLYTA® significantly prolonged mPFS vs. sorafenib in patients with advanced RCC previously treated with a sunitinib-based regimen*4
As of 1 November, 2011, INLYTA® sustained an improvement in mPFS vs. sorafenib in patients with advanced RCC previously treated with a sunitinib-based regimen†8
Adapted from Rini BI et al. 20114 and Motzer J et al. 2013.8
*As concluded by an independent radiology review committee assessment of PFS based on 31 Aug 2010 data cut-off. As of the data cut-off date of Aug 31, 2010, patients had received INLYTA® for a median duration of 6·4 months (range 0·03–22), and sorafenib for 5·0 months (range 0·03–20).4
†As of Nov 1, 2011, median duration of treatment was 8.2 months (range <0·1–33.4) with INLYTA® and 5.2 months (0.2–34.1) with sorafenib.8
Improved mPFS observed with INLYTA® versus sorafenib irrespective of first-line sunitinib treatment duration9
Adapted from Rini B, et al. ASCO GU 2012 (oral presentation; abstract 354).9
INLYTA® prolonged mPFS vs. sorafenib in patients with MSKCC favourable/ intermediate risk, non bulky disease, and no bone or liver metastases previously treated with a sunitinib-based regimen*†10
INLYTA® prolonged mPFS vs. sorafenib in patients with IMDC favourable/ intermediate risk, non bulky disease, and no bone or liver metastases previously treated with a sunitinib-based regimen*†10
Adapted from Bracarda S, et al. 2019.10
These retrospective post hoc analyses are limited by small patient numbers. P values were not adjusted for multiple comparisons and were considered exploratory.10 *Independent radiology review committee. PFS cut-off date: June 3, 2011. OS cut-off date: November 1, 2011.10†Two-sided unstratified log-rank test.10
Across subgroups, PFS (IRC accessed) was generally longer with patients treated with INLYTA® compared to sorafenib10
Adapted from Bracarda S, et al. 2019.10
INDICATION
INLYTA® is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine
SAFETY PROFILE
For the full safety profile of INLYTA®, please see INLYTA® Summary of Product Characteristics for Great Britain here or for Northern Ireland here.
For full details on managing a selection of the most common treatment-related adverse events with INLYTA®, visit the Safety Profile page here.
The most common (≥ 20%) adverse reactions observed following treatment with INLYTA® were diarrhoea, hypertension, fatigue, decreased appetite, nausea, weight decreased, dysphonia, palmar-plantar erythrodysaesthesia (hand-foot) syndrome, haemorrhage, hypothyroidism, vomiting, proteinuria, cough, and constipation
Abbreviations:
AE : adverse event, aRCC : advanced renal cell carcinoma, CI : confidence interval, CTCAE : Common Terminology Criteria for Adverse Events, ECOG : Eastern Cooperative Oncology Group, HR : hazard ratio, IMDC : International Metastatic Renal Cell Carcinoma Database Consortium, mOS : median overall survival, mPFS : median progression-free survival, MSKCC : Memorial Sloan Kettering Cancer Centre, PPE : palmar-plantar erythrodysaesthesia (hand-foot syndrome), RCC : renal cell carcinoma, SmPC : Summary of Product Characteristics, TRAEs : treatment-related adverse events
References
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc
This website is brought to you by Pfizer Limited, a company registered in England
and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ
Copyright © 2024 Pfizer Limited. All rights reserved.
VAT registration number GB201048427
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-UNP-GBR-7812. January 2024