FOTIVDA®▼ (tivozanib) Now Licensed in the European Union for the First-Line Treatment of Advanced Renal Cell Carcinoma

EUSA Pharma (EUSA), today announced that the European Commission (EC) has licensed FOTIVDA® for the management of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. Tivozanib is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) 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.¹ Tivozanib is an oral, once-daily*, potent selective vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKI).

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. However, we are still in need of effective and well tolerated new treatments in metastatic RCC and thus, tivozanib is a welcomed addition.”

The authorisation from the EC follows the recommendation from the Committee for Medicinal Products for Human Use (CHMP).² The decision was primarily based on data from global, open-label, randomised, multi-centre Phase III trial (TiVO-1)^1,3 which evaluated the efficacy and tolerability of tivozanib compared to a currently available comparator VEGFR-TKI treatment (sorafenib) in the treatment of 517 patients with advanced RCC. Patients treated with tivozanib experienced superior PFS (11.9 vs. 9.1 months in the overall 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]) versus sorafenib.³ There was also an improved side effect profile with tivozanib, with only 14% (versus 43% with sorafenib) requiring a dose reduction due to adverse events (AEs). In addition, fewer people on tivozanib experienced burdensome side effects, such as diarrhoea (23% vs 33%), and hand-foot syndrome (14% vs 54%).³

“Today’s licensing of tivozanib by the European Commission is an important step in expanding treatment options for patients with advanced renal cell carcinoma, where, despite advancements in therapy, survival rates in advanced disease remain low,” said Dr Jon Morgan, Medical Director, EUSA Pharma. “The licensing of tivozanib is supported by results from the TiVO-1 pivotal study which demonstrated efficacy of tivozanib as a first-line treatment.”

Lee Morley, EUSA Pharma’s Chief Executive Officer said, “Tivozanib has the potential to become an important new first-line therapy and the EU licensing is a great achievement for the EUSA team. EUSA Pharma is making great strides in building a leading specialty pharmaceutical business. In our short history we have made significant progress in expanding our portfolio of specialist medicines, and we look forward to further strengthening our portfolio focused in the oncology field.”

Following EC licensing, EUSA Pharma will now work with the necessary health authorities to make tivozanib available to advanced RCC patients across Europe as quickly as possible.

-ENDS-

NOTES TO EDITORS

About tivozanib and renal cell carcinoma (RCC)

Kidney cancer is the seventh most common cancer in Europe, with more than 115,000 new cases diagnosed each year.⁴ RCC is the most common form of kidney cancer, accounting for 80% of cases⁵ and there are an estimated 49,000 deaths from kidney cancer each year in Europe.⁶ 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.⁷

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 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 specialty pharmaceutical company with a focus on oncology and oncology supportive care. The company has commercial operations in the US 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 specialty pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners.

For more information visit www.eusapharma.com.

About AVEO

AVEO PHARMACEUTICALS, INC is a biopharmaceutical company that is focused on developing and commercialising its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor, 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma. AVEO is leveraging multiple partnerships to develop and commercialise tivozanib in non-oncologic indications worldwide and oncology indications outside of North America. For more information, please visit the company’s website at www.aveooncology.com.

References

*1340 microgram capsule
¹ http://ec.europa.eu/health/documents/community-register/index_en.htm
² CHMP summary of opinion. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004131/WC500229916.pdf Last accessed July 2017
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 July 2017.
⁵ 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 July 2017.
⁶ Cancer Research UK. Kidney Cancer Statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer#heading-One Last accessed July 2017.
⁷ 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 July 2017.

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Contact information

EUSA Pharma
Lee Morley
Chief Executive
Tel +44 (0) 330 5001140