New ESMO Guidelines Include FOTIVDA®▼(tivozanib) Recommendation for Patients with Advanced Renal Cell Carcinoma

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 21st 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,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,
4we
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 12th most commonly occurring cancer5
worldwide – the 9th in men and the 14th 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.

Contacts

Simon Goldsborough
Open Health Patient & Brand Communications
Tel
+44 (0)207 861 2808