HEMEL HEMPSTEAD, England -- (BUSINESS WIRE) --

EUSA Pharma (EUSA) welcomes the news that FOTIVDA^®▼ (tivozanib) has been included in the new European Society of Medical Oncology (ESMO) clinical practice guidelines for renal cell carcinoma (RCC), published on 21^st February 2019.¹

In the new guidelines tivozanib is included as a first-line treatment recommendation for advanced RCC (aRCC) clear cell histology patients. The guidelines have also positioned tivozanib as a treatment standard for good (or favourable) risk patients and a treatment option for intermediate risk patients.¹

Dr Bernard Escudier, Medical Oncologist and member of the Genitourinary Tumour Board of Gustave Roussy, France, commented “This is excellent news for patients with metastatic RCC. Outcomes in this disease have greatly improved with the introduction of targeted therapies, meaning that patients are living for longer, although currently available therapies can be associated with burdensome toxicities. We are still in need of effective and well tolerated new treatments in metastatic RCC and thus, tivozanib is a welcomed addition. We also look forward to continuing our investigations of potential combination approaches with other therapeutic agents.”

The inclusion of tivozanib in the new 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 improved progression free survival and lower rates of certain adverse events compared to those receiving another VEGFR-TKI, sorafenib.³

“I am pleased that the important European guidelines have been updated to include tivozanib as a recommendation for first line treatment for aRCC,” commented Lee Morley, Chief Executive Officer, EUSA Pharma. “With kidney cancer expected to be one of the fastest increasing cancers over the next ten years,⁴ we remain committed to ensuring the availability of tivozanib across the EU in line with the indication as a monotherapy in the first-line setting treatment of aRCC.”

Kidney cancer is the 12^th most commonly occurring cancer⁵ worldwide – the 9^th in men and the 14^th in women, with over 400,000 new cases in 2018.⁶ RCC is the most common form of kidney cancer, accounting for approximately 80% of cases.¹

^a 1340 microgram capsule

-ENDS-

NOTES TO EDITORS

About tivozanib

Tivozanib is an oral, once-daily,^b 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 aRCC.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.

^b 1340 microgram capsule

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 Escudier B, Porta C, Schmidinger M et al. Renal Cell Carcinoma: ESMO Clinical Practice Guidelines For Diagnosis and Treatment Follow Up. Available at: https://www.esmo.org/Guidelines/Genitourinary-Cancers/Renal-Cell-Carcinoma. Last accessed March 2019.

² European Medicines Agency. Fotivda. Available at: https://www.ema.europa.eu/medicines/human/EPAR/fotivda. Last accessed March 2019.

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 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 March 2019.

⁵ World Cancer Research Fund, Kidney cancer. Available at: https://www.wcrf.org/dietandcancer/kidney-cancer. Last accessed March 2019.

⁶ World Cancer Research Fund, Kidney cancer statistics. Available at: https://www.wcrf.org/dietandcancer/cancer-trends/kidney-cancer-statistics. Last accessed March 2019.