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GSK announces the start of a phase III study with eltrombopag in patients with myelodysplastic syndromes

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the start of a Phase III study, SUPPORT (TRC112121), to evaluate the platelet supportive care effects of eltrombopag (Promacta/Revolade) in combination with azacitidine (the current standard of care) versus placebo in combination with azacitidine in intermediate-1, intermediate-2 or high risk patients with myelodysplastic syndromes (MDS). The global study will assess the proportion of patients who are platelet transfusion free during the first four cycles of treatment.

MDS is a type of cancer in which the bone marrow does not make enough healthy blood cells and there are abnormal (blast) cells in the blood and/or bone marrow.[i] The disease usually manifests itself with 1 or more cytopenias, or reductions in the number of blood cells, and patients typically present with complications related to anaemia (fatigue), neutropenia (infections), or thrombocytopenia (bleeding).[ii] MDS may evolve into acute myeloid leukaemia (AML) in up to 45 percent of patients.[iii]

Dr. Rafael Amado, Senior Vice President Oncology RD at GSK, said:

“Cytopenias are important complications of MDS which tend to worsen with azacitidine treatment. Currently, there are no approved treatments for MDS that stimulate platelet production. The initiation of this study is an important step toward providing a potential treatment option that may support platelets and avoid transfusions in thromobocytopenic patients with MDS undergoing chemotherapy treatment.”

About the SUPPORT study

SUPPORT (StUdy of eltromboPag in myelodysPlastic SyndrOmes Receiving azaciTidine) is a Phase III, randomised, double-blind, placebo-controlled, multi-centre study of eltrombopag or placebo in combination with azacitidine in subjects with MDS. It is estimated that 350 patients across 30 countries and 156 study sites with a baseline platelet count of 75Gi/L, and intermediate-1, intermediate-2 or high risk MDS (by International Prognostic Scoring System) will be enrolled in the study. Eligible patients will be randomised to receive either eltrombopag (200 mg once daily [100 mg for East Asians]) plus azacitidine (75 mg/m2 subcutaneously once daily for 7 days) every 28 days, for at least 6 cycles, or placebo plus azacitidine. Dose modifications of eltrombopag or placebo will be permitted to ensure that patient platelet counts remain at a safe and effective level.

The primary efficacy endpoint will determine the platelet supportive care effects of eltrombopag in combination with azacitidine versus placebo in combination with azacitidine by comparing the proportion of subjects receiving eltrombopag plus azacitidine who are platelet transfusion free during the first four cycles of azacitidine, versus those treated with placebo plus azacitidine. Secondary objectives will compare the following between treatment arms: overall survival, disease response, haematologic improvement, platelet and red blood cell transfusions, adverse events (≥ Grade 3), safety and tolerability, health related quality of life and medical resource utilization.

About eltrombopag

Eltrombopag—marketed as Promacta in the U.S. and as Revolade in Europe and other countries across the world—works by interacting with the TPO receptor leading to increased platelet production. Eltrombopag is not approved or licensed anywhere in the world for use in patients with myelodysplastic syndromes.

For full US Prescribing Information for Promacta® (eltrombopag), including Boxed Warning, please visit: https://www.gsksource.com/gskprm/htdocs/documents/PROMACTA-PI-MG-COMBINED.PDF. For the European Union (EU) Summary of Product Characteristics (SPC) for Revolade® (eltrombopag) in approved indications, please visit http://health.gsk.com/.

Promactaand Revoladeare trademarks of the GSK group of companies.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

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References

[i] National Cancer Insitute. Myelodysplastic Syndromes Treatment (PDQ®). Available at: http://www.cancer.gov/cancertopics/pdq/treatment/myelodysplastic/Patient/page1. Accessed June 12, 2014.

[ii] Faderl S, Kantarjian H. Myelodysplastic Syndromes. In: Devita V, Hellman S, Rosenberg S, editor. Cancer: Principles Practice of Oncology 7th Edition. Philadelphia, PA:Lippincott, Williams Wilkins, 2005:2144-2154.

[iii] Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997; 89: 2079-2088.

Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.

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