Taiho Oncology, Inc. Announces Results from TAS-102 Global Phase III RECOURSE Trial in Refractory Metastatic Colorectal Cancer

– TAS-102 demonstrated a statistically significant improvement in overall survival and progression-free survival –

– Study findings form foundation for regulatory submissions in the U.S. and Europe –

BARCELONA, Spain and PRINCETON, New Jersey, June 28, 2014 /PRNewswire/ -- Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), announced today detailed findings from its global Phase III RECOURSE trial of TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug. TAS-102 achieved statistically significant improvements in overall survival (OS) and progression-free survival (PFS) in patients with refractory metastatic colorectal cancer (mCRC) whose disease had progressed after or who were intolerant to standard therapies. TAS-102 demonstrated a safety profile consistent with that observed in earlier clinical trials. The TAS-102 data were presented today during an oral presentation at the European Society for Medical Oncology (ESMO) 16th World Congress on Gastrointestinal Cancer in Barcelona, Spain.

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The TAS-102 RECOURSE trial met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR = 0.68, p < 0.0001). TAS-102 reduced the risk of mortality by 32% when compared to placebo. Median overall survival was 7.1 months (95% CI: 6.5-7.8) and 5.3 months (95% CI: 4.6-6.0) for TAS-102 and placebo, respectively, and was improved in favor of TAS-102 by 1.8 months. There was also a statistically significant 52% decrease in the risk of disease progression between the two arms (HR = 0.48, p < 0.0001). In addition, the disease control rate of patients treated with TAS-102 was 44.0% versus 16.3% for patients treated with placebo (p < 0.0001). These results were consistent across study regions.

"The results of the RECOURSE study demonstrate a clinically relevant improvement in the overall survival of patients treated with TAS-102 who have metastatic colorectal cancer that has progressed after treatment with standard therapies," said Professor Eric Van Cutsem, MD, PhD, (head Digestive Oncology), University Hospitals Leuven, Belgium.

The most commonly reported adverse events included hematological (anemia, neutropenia, and leukopenia) and gastrointestinal (diarrhea, nausea, and vomiting) events. Laboratory grade III/IV neutropenia in TAS-102 vs placebo was 37.9% vs 0%, anemia was 18.2% vs 3.0%, and thrombocytopenia was 5.1% vs 0.4%. Febrile neutropenia was 3.8% vs 0%. Grade III/IV diarrhea was 3.0% vs 0.4%, vomiting was 2.1% vs 0.4%, nausea was 1.9% vs 1.1%, fatigue was 3.9% vs 5.7%, and stomatitis was 0.4% vs 0%.

"Taiho is extremely pleased with the results of this important trial in refractory metastatic colorectal cancer. We would like to thank the patients and their families, who participated in this trial," said Fabio Benedetti, M.D., Taiho Oncology's Senior Vice President and Chief Medical Officer. "The TAS-102 RECOURSE study data presented will serve as the foundation for our regulatory submissions, which we plan in the U.S. at the end of 2014 and in Europe in the first quarter of 2015."

About The RECOURSE Study
The RECOURSE trial was a global, randomized, double-blind, placebo-controlled Phase III comparison trial evaluating the efficacy and safety of orally administered TAS-102 in patients with refractory mCRC. The trial enrolled 800 patients in North America, Japan, Europe and Australia who received at least two prior regimens of standard chemotherapies for mCRC and were refractory to, or failed, those chemotherapies. Patients were randomized (2:1) to receive TAS-102 (35 mg/m²) or placebo, plus best supportive care, twice daily. The primary objective of the RECOURSE trial was improvement in overall survival (OS) versus placebo.

The principal investigators are Dr. Robert J. Mayer of the Dana Farber Cancer Institute (USA), Dr. Eric Van Cutsem of the University Hospitals Leuven (Belgium) and Dr. Atsushi Ohtsu of the National Cancer Center (Japan).

About Metastatic Colorectal Cancer
Colorectal cancer is the third most common cancer worldwide. In 2014, it is estimated that 136,830 patients (71,830 men and 65,000 women) will be diagnosed with, and 50,310 patients will die from, cancer of the colon or rectum in the United States.^[i] Colorectal cancer was the second most common cancer in Europe in 2012. In addition, it was estimated that 447,000 patients (242,000 men and 205,000 women) were diagnosed with and 215,000 patients died of colorectal cancer in Europe during 2012.^[ii]

About TAS-102
TAS-102 is an oral combination anticancer drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase.

About Taiho Oncology, Inc.
Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. and Otsuka Holdings Co., Ltd., has built a world class clinical development organization that works urgently to develop innovative cancer treatments and is in the process of building commercial businesses in the USA and Europe. Taiho has an oral oncology pipeline consisting of both novel antimetabolic agents and selectively targeted agents. Advanced technology, dedicated researchers, and state of the art facilities are helping us to define the way the world treats cancer. It's our work; it's our passion; it's our legacy.

For more information about Taiho Oncology, please visit: www.taihooncology.com 

About Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma focusing on the three fields of oncology, allergies and immunology, and urology. Its corporate philosophy takes the form of a pledge: "We strive to improve human health and contribute to a society enriched by smiles." In the field of oncology in particular, Taiho Pharmaceutical is known as a leading company in Japan and around the world for developing innovative medicines for the treatment of cancer. In areas other than oncology, as well, the company creates quality products that effectively treat medical conditions and can help improve people's quality of life. Always putting customers first, Taiho Pharmaceutical also aims to offer over-the-counter medicinal products that support people's efforts to lead fulfilling and rewarding lives.

For more information about Taiho Pharmaceutical, please visit http://www.taiho.co.jp/english/.

About Otsuka Holdings Co., Ltd.
The Otsuka Group is a global organization of 166 healthcare companies with nearly 44,000 employees. Otsuka Holdings Co., Ltd. is the Group's holding company. The Group operates in 26 countries and regions, conducting diversified businesses in four segments all connected by a focus on health: pharmaceuticals, nutraceuticals, consumer products, and others.

The Group's corporate philosophy of "Otsuka-people creating new products for better health worldwide," is supported by the corporate ethic of "JISSHO (Proof through Execution) and SOZOSEI (Creativity)." The Otsuka Group thus seeks to foster a culture and vitality appropriate to an enterprise involved with human health and to create innovative products that contribute to the health and wellness of people worldwide.

For more information, please visit the company's website at http://www.otsuka.com/en/.

Media Contact:
Chris Bath
Sentrix Health for Taiho Oncology, Inc.
chris.bath@sentrixhealth.com
+44 (0) 7552 211914

References
[i] Cancer facts & figures 2014. American Cancer Society.
[ii] Ferlay, J. et. al. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012. European Journal of Cancer. 49; 1374-1403.