EUSA-PHARMA

EUSA Pharma (EUSA) welcomes the news that FOTIVDA®▼ (tivozanib) is expected to be included in the upcoming European Society of Medical Oncology (ESMO) clinical practice guidelines for advanced renal cell carcinoma (aRCC), anticipated to be published at the end of this year.¹

The outline of the new proposed guidelines was presented on 19^th October at the annual ESMO 2018 Congress in Munich, Germany, and indicated that tivozanib will be included as a first-line treatment recommendation for aRCC clear cell histology patients. The update will position tivozanib as a treatment standard for good (or favourable) risk patients with a Class IIa recommendation, and a treatment option for intermediate risk patients with a Class IIb recommendation.¹

The indication of inclusion of tivozanib in the ESMO guidelines follows the grant of a European Commission (EC) licence in August 2017 for this oral, once-daily,^a potent selective vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKI) as first-line treatment of adult patients with aRCC.²

The authorisation within the European Union (EU) was based on evidence from the global, open-label, randomised, multi-centre Phase III trial TiVO-1,³  which showed that aRCC patients receiving tivozanib experienced superior progression free survival and an improved side effect profile compared to those receiving another VEGFR-TKI, sorafenib.³

“EUSA Pharma are pleased to receive this indication of the inclusion of tivozanib in such important European guidelines reflecting both its EU authorisation and the potential patient benefits as a result of its efficacy and tolerability profile,” said Lee Morley, Chief Executive, EUSA Pharma. “We continue to progress the launch of FOTIVDA across the EU in line with the indication as a monotherapy in the first-line setting treatment of advanced renal cell carcinoma.”

Kidney cancer is the seventh most common cancer in Europe⁴ and the 14^th worldwide,⁵ with over 400,000 new cases in 2018.⁵ RCC is the most common form of kidney cancer, accounting for 80% of cases⁶ and there are an estimated 49,000 deaths from kidney cancer each year in Europe, 143,000 globally. ⁷ Kidney cancer is expected to be one of the fastest increasing cancers over the next ten years as a result of Europe’s ageing population, with smoking and a rise in obesity also playing a part.⁸

-ENDS-

NOTES TO EDITORS

About tivozanib

Tivozanib is an oral, once-daily,^a potent selective vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKI). It is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (aRCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.²

An over-expression of VEGF protein, and a resulting increase in tumour blood supply (angiogenesis), is a common feature of RCC.³ VEGFR-TKIs reduce the supply of blood to the tumour and are the recommended first-line treatment for advanced RCC in Europe, however, patients often experience significant side effects including fatigue, diarrhoea, and hand-foot syndrome.

In the global Phase III trial (TiVO-1)³ of over 500 patients with advanced RCC, tivozanib demonstrated a significant progression free survival (PFS) benefit versus sorafenib (11.9 vs. 9.1 months in the overall patient population [HR, 0.797; 95% CI, 0.639 to 0.993; P =.042], and 12.7 vs. 9.1 months in treatment-naïve patients [HR, 0.756; 95% CI, 0.580 to 0.985; P =.037]).³ There was also an improved side-effect profile versus sorafenib, with significantly fewer patients on tivozanib (14% versus 43%) requiring a dose reduction due to AEs; and less than 5% of patients experiencing severe side effects (grade 3&4, such as diarrhoea, asthenia (physical weakness) and hand-foot syndrome. Hypertension (44%) and dysphonia (21%) were the most commonly reported AEs on tivozanib.³

Under EUSA Pharma’s license agreement with AVEO PHARMACEUTICALS, INC, announced in December 2015, the company holds exclusive commercialisation rights to tivozanib in RCC in Europe and in a number of other territories outside North America, including South America and South Africa. Under the terms of the agreement, EUSA Pharma will undertake and fund the commercialisation of the product in its territories, assuming licensing. AVEO PHARMACEUTICALS, INC retains the rights to commercialise the product in North America. Tivozanib was discovered by Kyowa Hakko Kirin.

About EUSA Pharma

Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company has commercial operations in the United States and Europe, and a wider distribution network in approximately 40 countries around the world. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information, please visit www.eusapharma.com .

References

¹ Systemic first-line treatment of ccRCC, as part of the “State of the art for systemic treatments in kidney and bladder cancers” presented at ESMO 2018 congress, Munich, 19^th October 2018.

² European Medicines Agency. Fotivda. Available at: https://www.ema.europa.eu/medicines/human/EPAR/fotivda . Last accessed October 2018.

³ Motzer R.J; Nosov D et al. Tivozanib Versus Sorafenib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma: Results From a Phase III Trial. Journal of Clinical Oncology. Volume 31. 2013: 30:3791

⁴ Cancer Research UK, Kidney Cancer Incidence. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer/incidence#heading-Ten . Last accessed October 2018.

⁵ World Cancer research Fund, Kidney cancer statistics. Available at: https://www.wcrf.org/dietandcancer/cancer-trends/kidney-cancer-statistics . Last accessed October 2018.

⁶ Escudier B; Porta C et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 27 (Supplement 5). 2016: v58–v68. Available at: http://www.esmo.org/Guidelines/Genitourinary-Cancers/Renal-Cell-Carcinoma . Last accessed October 2018.

⁷ Cancer Research UK. Kidney Cancer Statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer#heading-One . Last accessed October 2018.

⁸ Cancer Research UK. Kidney cancer rates are increasing, so what’s fuelling the surge? Available at: http://scienceblog.cancerresearchuk.org/2017/04/24/kidney-cancer-rates-are-increasing-so-whats-fuelling-the-surge/ . Last accessed October 2018.

^a 1340 microgram capsule

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Contact:

EUSA Pharma Lee Morley, +44 (0) 330 5001140 Chief Executive or Reynolds-MacKenzie Chiara Ennas, +44 (0) 207 861 2558

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