Pfizer Limited has announced that Inlyta® (axitinib), a new treatment for adult patients with advanced renal cell carcinoma (RCC) – a form of kidney cancer – has been launched in the UK. Axitinib, a tyrosine kinase inhibitor (TKI), is licensed for the treatment of adult patients with advanced RCC after failure of prior treatment with sunitinib or a cytokine. RCC is the most common form of kidney cancer and accounts for 90% of all kidney cancers, with over 9,000 new cases of kidney cancer diagnosed in the UK in 2009. Approximately 30% of RCC patients will have advanced disease and approximately 60% of first-line UK patients are suitable for second-line therapy.
The licence is based on data from the Phase III AXIS trial of 723 patients which demonstrated that axitinib significantly extended progression free survival (PFS) [HR=0.67, 0.56-0.81, P<0.0001] with a median average PFS of 6.8 months (95% CI: 6.4, 8.3) compared with 4.7 months (95% CI: 4.6, 6.3) for those treated with sorafenib, a current standard of care for this patient population. This represents a 45% improvement in median PFS compared to sorafenib.1 PFS favoured axitinib in both the prior cytokine subgroup (12.0 vs 6.6 months; HR 0•52 (0•38, 0•72) P<0.0001) and the prior sunitinib subgroup (4.8 vs 3.4 months; HR 0•74 (0•58, 0•94), P=0.0063).
“Today’s news marks an important step for the future treatment of patients with this devastating cancer. The strength of data supporting the treatment of patients with axitinib after progression on treatment with sunitinib or a cytokine is very encouraging” said Dr Tom Powles, Consultant Oncologist, Barts Health NHS Trust, London. “Furthermore, there is a growing body of evidence to support the sequential use of different TKI agents in the treatment of people with advanced kidney cancer. The data from the AXIS trial provides further evidence to support this approach” he continued.
When first-line therapies stop working, the prognosis for most patients is poor. For these people, there is a clear need for an effective second-line therapy in order to maintain their quality of life while delaying disease progression. However, existing guidance issued by the National Institute for Health and Clinical Excellence (NICE) does not recommend any second-line therapy for the treatment of advanced RCC. At present, the only available route for patients in England to access second-line therapies is through the Cancer Drugs Fund (CDF). Recent evidence shows that patients in Wales, Northern Ireland and Scotland are still not routinely being prescribed these medicines. Axitinib is currently being appraised by NICE, and Pfizer is intending to submit to the Scottish Medicines Consortium (SMC) imminently.
“We are delighted with this news and look forward to sharing it with patients and their families,” said James Whale, Chairman and Founder of the James Whale Fund, which specialises in supporting people with kidney cancer. “Kidney cancer remains a devastating disease and any chance of improving quality of life by delaying cancer progression represents a significant milestone. However, patient access to this new medicine is not in our hands and we can only look to Health Technology Assessment bodies around the UK to make it available on the NHS in the coming months.”
It is estimated that by 2020 the incidence of kidney cancer in the UK will increase by 17% and currently 25% of all cases are directly linked to obesity. Kidney cancer is a rare, yet serious disease. At diagnosis, approximately 30% of kidney cancer patients will have advanced (metastatic) disease, where the cancer has spread to other parts of the body. Kidney cancer is the 8th most common cancer in the UK , with an estimated 3,850 people dying from the disease each year.
“Pfizer has a strong commitment to advancing therapies for patients with advanced RCC,” said Dr David Montgomery, Medical Director, Pfizer Oncology UK. “Axitinib is the latest result of the dedication of Pfizer researchers, as well as the hard work of clinicians around the world to advance this field. Axitinib is a major step forward for UK kidney cancer patients and Pfizer is committed to working with the NHS to enable patients to get the most benefit from this new treatment.”
Axitinib, an oral therapy, is designed to potently and selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, which are crucial in influencing tumour growth, vascular angiogenesis (development of tumour blood supply) and progression of cancer (tumour spread). Axitinib is the first VEGFR-TKI proven to be superior over an active comparator in a purely second-line population in a randomised phase III open label trial.5 Axitinib is also approved for the treatment of advanced RCC in US, Canada, Switzerland, Australia and Japan.
Last updated on: 11/10/2012