LONSURF® Receives a Positive Recommendation from the Pan-Canadian Oncology Drug Review for the Treatment of Adults with Metatastic Gastric Cancer

This oral medication addresses a vital unmet need as it has been shown to significantly improve survival among patients with few treatment options

OAKVILLE, ON, March 27, 2020 /CNW/ - Taiho Pharma Canada, Inc., a Canadian subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced that the pan-Canadian Oncology Drug Review (pCODR) recommends reimbursement for LONSURF® (trifluridine and tipiracil [as tipiracil hydrochloride] tablets) for the treatment of adult patients with metastatic gastric (stomach) cancer or adenocarcinoma of the gastroesophageal junction.ⁱ LONSURF is a treatment for patients who have been previously treated with at least two prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan and if appropriate with HER2/neu-targeted therapy.ⁱⁱ

The pCODR clinical guidance panel concluded that there is a net overall clinical benefit to LONSURF in the treatment of advanced gastric adenocarcinoma after progression on two prior lines of chemotherapy based on a high-quality randomized controlled trial (TAGs) that demonstrated a clinically and statistically significant benefit in overall survival compared with placebo. In addition, the adverse event profile for LONSURF was manageable and there was no difference in quality of life compared to placebo.ⁱⁱⁱ LONSURF addresses a vital unmet medical need among people living with metastatic gastric cancer as it is the only drug approved in Canada to treat these patients in the third-line treatment setting and beyond.

"This positive recommendation is good news for patients with end-stage metastatic gastric cancer who have few treatment options to extend their survival," said Dr. Christine Brezden-Masley, medical director of the Cancer Program at Sinai Health. "LONSURF provides a much-needed treatment option in the third-line setting or beyond for Canadian patients where no options existed before. Since the data shows that the treatment has the potential to extend overall survival for some of these patients, it is vital they can access it. I am hopeful that the pCODR recommendation will open the doors to public reimbursement, which may allow more patients to benefit and extend their survival."

It is estimated that more than four thousand Canadians are diagnosed with gastric cancer and nearly two thousand will die from the disease each year.^iv Most gastric cancers are diagnosed when the disease is advanced and has spread to other sites of the body.^v

"We know all too well how devastating it is for those living with metastatic gastric cancer to be unable to access approved treatment options that may prolong their lives and allow them to spend more quality time with their loved ones," said Teresa Tiano, Chair and Co-Founder of My Gut Feeling - Stomach Cancer Foundation of Canada. "We are hopeful that this positive recommendation from pCODR will encourage health authorities across the country to provide public access to this important treatment option as soon as possible so that patients who may benefit from this therapy can do so no matter where they live in Canada."

"At Taiho Pharma, we are united in our goal of helping people with advanced cancers to live longer and with a better quality of life," said Ross Glover, General Manager of Taiho Pharma Canada Inc. "We applaud pCODR's decision and are actively working with provincial authorities across Canada to ensure public reimbursement is available to eligible patients who can benefit from this treatment."

About LONSURF
LONSURF is an oral nucleoside antitumor agent discovered and developed by Taiho Pharmaceutical Co., Ltd. LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation. 

LONSURF is also approved by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) as well as the Ministry of Health, Labour and Welfare (MHLW), as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma.  In addition, LONSURF is approved in Canada for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents.^vi  As of March 2020, LONSURF has been approved as a treatment for advanced metastatic gastric cancer in 42 countries and regions worldwide.

Since 2015, Taiho Pharmaceutical and Servier have been in an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico, and Asia.^vii

About Taiho Pharma Canada, Inc. (Canada) Taiho Pharma Canada, Inc., a Canadian subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), is located in Oakville, Ontario and managed by Taiho Oncology, Taiho's U.S. R&D and commercial operations, based in Princeton, New Jersey. Taiho Oncology has established world-class clinical development and commercial organizations that work urgently to develop and market innovative cancer treatments in the U.S. and Canada. Taiho Oncology Inc. has an oral oncology pipeline consisting of both novel anti-metabolic agents and selectively targeted agents. Advanced technology, dedicated researchers, and state of the art facilities are helping Taiho define the way the world treats cancer. It's our work; it's our passion; it's our legacy.

For more information about Taiho Pharma Canada, please visit: https://www.taihopharma.ca/en/.

LONSURF® (trifluridine and tipiracil [as tipiracil hydrochloride] tablets) monotherapy is indicated for the treatment of adult patients with metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan and if appropriate with HER2/neu-targeted therapy.

LONSURF® (trifluridine and tipiracil [as tipiracil hydrochloride] tablets) is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents.

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i pan-Canadian Oncology Drug Review Final Clinical Guidance Report. March 24, 2020. https://www.cadth.ca/trifluridine-tipiracil-lonsurf-gastric-cancer-details.

ii Taiho Pharma. LONSURF® Product Monograph. Updated 2019.

iii pan-Canadian Oncology Drug Review Initial Clinical Guidance Report. March 2, 2020. https://www.cadth.ca/trifluridine-tipiracil-lonsurf-gastric-cancer-details.

iv Canadian Cancer Society. Stomach Cancer Statistics 2019. Available at: https://www.cancer.ca/en/cancer-information/cancer-type/stomach/statistics/?region=on

v Shitara, K., Doi, T., Dvorkin, M., et al. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology. 2018;19(11): 1437-1438. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30739-3/fulltext.

vi Taiho Pharma. LONSURF® Product Monograph. Updated 2019.

vii Servier is an international pharmaceutical company governed by a non-profit foundation with its headquarters in France (Suresnes).  More information: www.servier.com

SOURCE Taiho Pharma Canada, Inc.

FOR MEDIA INFORMATION: Fiona Buchanan, [email protected], [phone]