Servier announce updated overall survival results of exploratory TASCO1 phase II study of LONSURF ® + bevacizumab in a first-line setting for patients with unresectable mCRC non-eligible for intensive therapy

Servier announced today updated results from the exploratory phase II TASCO1 study evaluating LONSURF^® (trifluridine/tipiracil) + bevacizumab and capecitabine + bevacizumab (C-B) in a first-line setting for patients with unresectable metastatic colorectal cancer (mCRC) who are non-eligible for intensive therapy.¹ The data were announced today during an oral presentation at the 2021 ASCO Gastrointestinal Cancers Symposium (ASCO-GI). Patients with mCRC who are not eligible for chemotherapy face a large unmet need, with fewer treatment options available to them and lower survival rates.

Colorectal cancer (CRC) makes up 9.7% of total global cancer cases, with almost 1.4 million new cases of CRC each year.² In Europe, CRC is the second most common cause of death due to cancer, and those with a metastatic disease have a 5-year survival rate of just 11%.³

“For patients with metastatic colorectal cancer, those non-eligible for standard combination therapy have few options left and we are continuously searching for new ways to give these patients more hope,” said Professor Eric Van Cutsem, Leuven, Belgium “The data from TASCO1 are very encouraging and provide evidence that trifluridine/tipiracil + bevacizumab is a beneficial treatment combination for these patients.”

In the exploratory phase II TASCO1 study, 153 patients were randomized and followed until September 1, 2020.¹ The updated results showed that the median overall survival (OS) was 22.3 months with LONSURF + bevacizumab, whereas it was 17.6 months with C-B. This data translates into an improved median OS of 4.6 months with LONSURF + bevacizumab when compared with C-B (HR, 0.78; 95% CI, 0.55, 1.10). The survival probability at 18 months with LONSURF + bevacizumab was 0.62 (95% CI, 0.50, 0.72) and 0.47 (95% CI, 0.35, 0.57) with C-B.¹ It should be noted that this was an exploratory, non-comparative study.

“We are very pleased with the updated results from the phase II TASCO1 study and we are continuing with our research into this promising combination in multiple mCRC settings. These data support all efforts that went into the confirmatory phase III SOLSTICE study. The results are expected in 2021,” said Patrick Therasse, M.D., Ph. D., Head of Servier Late Stage and Life Cycle Management Oncology, “Patients with mCRC who are not eligible for intensive chemotherapy have limited options and further clinical trials for additional treatments are highly anticipated by the clinical and patient communities alike.”

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About TASCO1

TASCO1 is an open-label, randomized, non-comparative Phase II study evaluating LONSURF^® + bevacizumab and capecitabine plus bevacizumab in patients with previously untreated metastatic colorectal cancer who are non-eligible for intensive therapy. From April 2016 to March 2017, 153 patients were randomized and followed until end-of-study on September 1, 2020. The primary endpoint was progression-free survival, and the key secondary endpoint was overall survival.

For more information on TASCO1, please visit www.ClinicalTrials.gov (https://www.clinicaltrials.gov/ct2/show/NCT02743221). The ClinicalTrials.gov Identifier is NCT02743221.

About SOLSTICE

SOLSTICE is an open-label, randomized, multicentre Phase III trial in 854 unresectable metastatic colorectal cancer patients who are not candidates for, or do not require, intensive therapy. Patients were randomized 1:1 to receive first-line LONSURF^® + bevacizumab versus capecitabine + bevacizumab. The primary objective is to demonstrate superior progression-free survival with LONSURF^® + bevacizumab over capecitabine + bevacizumab. The first patient was enrolled in March 2019. Results are expected in 2021.

For more information on SOLSTICE, please visit www.ClinicalTrials.gov (https://www.clinicaltrials.gov/ct2/show/NCT03869892). The ClinicalTrials.gov Identifier is NCT03869892.

About Metastatic Colorectal Cancer (mCRC)

Colorectal cancer is the third most common cancer worldwide with approximately 1.8 million new diagnoses in 2018. Each year there are over 880,000 deaths, making it the second biggest cancer killer worldwide (after lung cancer).³

For those with metastatic disease (where the cancer has spread from the primary site), the average 5-year survival is approximately 11%.⁴ Standard chemotherapy regimens for advanced mCRC include fluoropyrimidines, oxaliplatin, irinotecan or targeted treatments, such as those that target vascular endothelial growth factors (VEGF) or endothelial growth factor receptors (EGFR).

Over the last decade, clinical outcomes for patients with mCRC have improved considerably due to the advent of novel treatment agents, predictive biomarkers, and a more strategic approach to the delivery of systemic therapies. Currently, the median overall survival for patients with mCRC being treated both in phase III trials and in large observational series or registries is 30 months – more than double that of 20 years ago.^5,6,7

About LONSURF^®8

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.

In the EU, LONSURF^® is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti- VEGF agents, and anti-EGFR agents. LONSURF^® is also indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer (mGC), including adenocarcinoma of the gastroesophageal junction (mGEJC), who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

As of November 2020, LONSURF^® has been approved in 91 countries for the treatment of advanced mCRC and in 56 countries for the treatment of advanced mGC/mGEJC.

LONSURF^® was discovered and developed by Taiho Pharmaceutical. In June 2015, Taiho Pharmaceutical and Servier entered into 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.

About Servier

Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 150 countries and a total revenue of 4.6 billion euros in 2019, Servier employs 22,000 people worldwide. Entirely independent, the Group invests on average 25% of its total revenue (excluding generics) every year in research and development and uses all its profits for its development. Corporate growth is driven by Servier’s constant commitment in five areas of excellence: cardiovascular, immune-inflammatory, and neurodegenerative diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development. More information: www.servier.com

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¹ Van Cutsem E, Danielewicz I, Saunders MP, et al. Phase II study evaluating trifluridine/tipiracil + bevacizumab and capecitabine + bevacizumab in first-line unresectable metastatic colorectal cancer (mCRC) patients who are non-eligible for intensive therapy (TASCO1): results of the final analysis on the overall survival. ASCO GI 2021.

² Digestive Cancers Europe. Prevalence of Colorectal Cancer. https://digestivecancers.eu/colorectal-cancer/prevalence-of-colorectal-cancer-prevalence/?menu_id=13873 Last accessed December 2020.

³ World Health Organisation. GLOBOCAN. Cancer today. Estimated age-standardized incidence rates (World) in 2018, all cancers, both sexes, all ages. https://gco.iarc.fr/today/online-analysis-map?v=2018&mode=population&mode_population=continents&population=900&populations=900&key=asr&sex=0&cancer=39&type=0&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&nb_items=10&group_cancer=1&include_nmsc=1&include_nmsc_other=1&projection=natural-earth&color_palette=default&map_scale=quantile&map_nb_colors=5&continent=0&rotate=%255B10%252C0%255D Last accessed May 2020.

⁴ American Cancer Society. Survival Rates for Colorectal Cancer, by Stage. https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html Last accessed December 2020.

⁵ Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet (London, England). 2014;383(9927):1490-1502.

⁶ Price TJ, Segelov E, Burge M, et al. Current opinion on optimal systemic treatment for metastatic colorectal cancer: outcome of the ACTG/AGITG expert meeting ECCO 2013. Expert Rev Anticancer Ther. 2014;14(12):1477-1493.

⁷ Van Cutsem E, Cervantes A, Adam R, et al. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016;27(8):1386-1422.

⁸ European Medicines Agency. LONSURF European Public assessment report. https://www.ema.europa.eu/en/medicines/human/EPAR/LONSURF#authorisation-details-section Last accessed December 2020.

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