SERVIER
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.”
#ENDS#
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
Follow us on Social Media:
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210116005002/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Deciphera Announces Oral Presentation of Positive Topline Results from Phase 2a Study of Sapablursen in Polycythemia Vera at the 67th American Society of Hematology (ASH) Annual Meeting6.12.2025 15:30:00 CET | Press release
Results from Phase 2a IMPRSSION study demonstrate sapablursen significantly reduced phlebotomy rate, controlled hematocrit and increased serum hepcidin Sapablursen was generally safe and well tolerated Results support further development of sapablursen in a Phase 3 study Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced the oral presentation of positive results from the Phase 2a IMPRSSION study of sapablursen in patients with polycythemia vera (PV) at the 67th American Society of Hematology (ASH) Annual Meeting, taking place December 6-9, 2025, in Orlando, FL. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251206361611/en/ The results were presented by Ionis Pharmaceuticals, who discovered and developed sapablursen and conducted the IMPRSSION study. In March 2025, Ionis and Ono entered into a license agreement in which On
Protagonist and Takeda Present Longer-Term Data at ASH 2025 Showing Rusfertide Delivers Durable Response and Hematocrit Control in Polycythemia Vera6.12.2025 15:30:00 CET | Press release
52-Week Results from the Phase 3 VERIFY Study of Rusfertide Demonstrated Sustained Hematocrit Control and Response, Defined by Absence of Phlebotomy Eligibility, with No New Safety SignalsThese Data Build on Positive 32-Week Primary Analysis from VERIFY, Which Met its Primary Efficacy Endpoint and All Four Key Secondary EndpointsPatients Crossing Over from Placebo to Rusfertide at 32 Weeks Achieved a Similar Response Rate to Those Initially Randomized to Rusfertide, with 77.9% Achieving Absence of Phlebotomy Eligibility Between Weeks 40-52Four-Year Results from the Combined REVIVE and Long-Term Extension THRIVE Study Demonstrated a 13-Fold Reduction in Annual Rate of Phlebotomies from Baseline Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) announce that new 52-week results from the pivotal Phase 3 VERIFY study evaluating rusfertide in patients with polycythemia vera (PV) will be presented in an oral presentation at the 67th American Society
Vertex Presents New Data on CASGEVY®, Including First-Ever Data in Children Ages 5-11 Years, at the American Society of Hematology Annual Meeting and Announces Plan for Global Regulatory Submissions6.12.2025 13:01:00 CET | Press release
- Data from pivotal studies of CASGEVY in children ages 5-11 years with severe sickle cell disease or transfusion-dependent beta thalassemia demonstrates the transformative potential of the therapy in younger patients -- Efficacy and safety data in children 5-11 years are consistent with the durable and positive benefit/risk profile established from clinical studies in patients 12 years of age and older -- Vertex expects to initiate global regulatory submissions for CASGEVY in children 5-11 years in 1H 2026 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data from multiple studies demonstrating the clinical benefits of CASGEVY® (exagamglogene autotemcel) in people ages 5 years and older living with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT). The results, including the first presentation of clinical data from pivotal studies in children ages 5-11 years, and longer-term data from the pivotal studies of people with severe SCD and
Leading Global Scientists Gather at Tengchong Scientists Forum to Explore Innovative Pathways in Frontier Technologies6.12.2025 12:31:00 CET | Press release
The 2025 Tengchong Scientists Forum opened on Saturday in southwest China’s Yunnan Province, convening leading scientists and academic figures to examine innovation across frontier fields including artificial intelligence, biodiversity and quantum technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251205499197/en/ Opening ceremony of Tengchong Scientists Forum on 6th December, 2025 Notable participants include Nobel Physics laureate Konstantin Novoselov, Fields Medalist Efim Zelmanov and Turing Award winner Andrew Chi-Chih Yao, who join 127 academicians, 77 university presidents from China and abroad, over 400 scholars and more than 600 entrepreneurs and financiers. The gathering aims to deepen collaboration between cutting-edge research and industrial development. Under the theme “Science · AI changing the World,” the forum features ten sub-forums, academic sessions and thematic events supporting major cooperation p
Lattice Wins 2025 Global Semiconductor Alliance Award6.12.2025 00:49:00 CET | Press release
‒ Named Most Respected Public Semiconductor Company Achieving $100 Million to $500 Million in Annual Sales ‒ Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, today announced that it was selected as ‘Most Respected Public Semiconductor Company’ at the 2025 Global Semiconductor Alliance (GSA) Awards. The GSA awards recognize companies that have demonstrated excellence through their success, vision, strategy, and future opportunities in the industry as determined by votes from GSA members. “We are honored to be recognized by the Global Semiconductor Alliance and our peers as one of 2025’s most respected public semiconductor companies. This recognition reflects the dedication of the Lattice team and the trust of our customers, partners, suppliers, and investors. Looking ahead, we remain laser-focused on driving innovation and strengthening our role as the trusted low power programmable leader for semiconductor and system solutions,” said Ford Tamer, Chief Executive
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom