Efficacy and Safety of Trifluridine/tipiracil (TAS-102) Combined with Bevacizumab and Putalimab in the Treatment of Patients with MCRC After Cytoreductive Surgery: a Single-arm, Single-center Clinical Study

Colorectal cancer (CRC) is one of the most common malignant tumors. With the rapid development of China's economy, people's living standards have been significantly improved, and lifestyles and dietary structures have changed. Smoking, drinking, high-fat, high-energy diets, etc. have led to an increase in the incidence of colorectal cancer year by year. Data show that in 2022, there will be 510,000 new cases of colorectal cancer in China, and about 240,000 deaths related to colorectal cancer. Radical surgery is the main initial treatment for early and middle-stage colorectal cancer and some metastatic colorectal cancer. Although the level of surgical treatment of colorectal cancer has been greatly improved and can achieve cure for some patients, its 5-year overall survival rate is only about 60%, and the main cause of death is distant metastasis and recurrence. In recent years, with the in-depth understanding of the treatment mechanism of metastatic colorectal cancer (mCRC), a variety of new treatment options have been proposed and applied in clinical practice in order to improve the quality of life of patients and prolong their survival.
Trifluridine/tipivirine (TAS-102) is a new type of cytotoxic drug that exerts anti-tumor effects by directly incorporating into DNA chains to destroy DNA function. Its mechanism of action is different from that of fluorouracil drugs, and it can resist 5-fluorouracil (5-FU) resistance, providing a new treatment option for mCRC patients. TAS-102 has been approved in China for mCRC patients who have previously received fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, as well as those who have previously received or are not suitable for anti-vascular endothelial growth factor (VEGF) therapy and anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type). Bevacizumab, as a monoclonal antibody targeting VEGF, exerts its anti-tumor effect by inhibiting tumor angiogenesis. Putlimumab, as an immune checkpoint inhibitor, enhances the body's immune response to tumors by blocking the PD-1/PD-L1 signaling pathway.
Combination therapy has attracted much attention due to its possible synergistic effect. Studies have shown that TAS-102 combined with bevacizumab can achieve longer overall survival (OS) than TAS-102 monotherapy. In addition, TAS-102 combined with bevacizumab for refractory mCRC has also been approved by the FDA, showing its potential and importance in the treatment of mCRC. Therefore, this study aims to explore the efficacy and safety of TAS-102 combined with bevacizumab and putelimab in patients with mCRC after cytoreductive surgery, in order to provide a more effective treatment for mCRC patients. Through the design of a single-arm, single-center clinical study, we can have a deeper understanding of the efficacy and safety of this combined treatment in a specific patient population, providing a scientific basis for future clinical applications.

开始日期2025-05-01

申办/合作机构

浙江大学医学院附属第二医院（浙江省第二医院）

NCT06873763

/ Not yet recruiting临床1/2期

A Multi-center, Single-group, Open Phase Ib/2 Study of Nelmastobart in Combination with Trifluridine/Tipiracil and Bevacizumab in Metastatic Colorectal Cancer Patients with Resistance or Intolerance to Oxaliplatin and Irinotecan-based Chemotherapy

The objective of this multi-center, single-group, open-label Phase Ib/II study is to evaluate the safety, pharmacokinetics, and efficacy of nelmastobart in combination with trifluridine/tipiracil and bevacizumab in metastatic or recurrent colorectal cancer patients with resistance or intolerance to oxaliplatin- and irinotecan-based chemotherapy, and to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and the efficacy and safety of the combination therapy in BTN1A1-positive patients.

开始日期2025-05-01

申办/合作机构

STCube, Inc.

NCT06607458

/ Not yet recruiting临床2期

An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment with Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients with Refractory Metastatic Colorectal Cancer with Liver Dominant Disease

The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with colorectal cancer that has spread to the liver is safe and tolerable. The clinical trial will also learn if the liver-directed therapy with high dose chemotherapy works on the disease in the liver. Investigators will compare the use of the liver-directed therapy with high dose chemotherapy followed by approved cancer treatment or approved cancer treatment alone.
Participants will:
* Undergo up to two liver-directed therapy with high dose chemotherapy procedures followed by approved cancer treatment or take approved cancer treatment alone
* Visit clinic at least every two weeks for checkups and tests
* Complete scans approximately every two months

开始日期2025-05-01

申办/合作机构

Delcath Systems, Inc.

100 项与曲氟尿苷替匹嘧啶相关的临床结果

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100 项与曲氟尿苷替匹嘧啶相关的专利（医药）

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项与曲氟尿苷替匹嘧啶相关的文献（医药）

2025-04-01·Cancer Medicine

Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy in Resectable Esophageal and Gastroesophageal Junction Adenocarcinoma: A Phase II Study

Article

作者: Fungtammasan, Arkarachai ; Yu, Han ; Fujiwara, Yu ; Chatley, Sarah ; Attwood, Kristopher ; Kukar, Moshim ; Fountzilas, Christos ; Hatoum, Hassan ; Pattnaik, Harsha ; Liao, Chih‐Yi ; Brown, Alyson ; George, Anthony ; Spickard, Erik ; Catalfamo, Kayla ; George, Sagila ; Mukherjee, Sarbajit ; Advani, Shailesh ; Iyer, Renuka ; Vadehra, Deepak

ABSTRACT:

Background:

Preoperative chemoradiation (CRT) followed by surgery for localized esophageal and gastroesophageal junction adenocarcinoma (EGAC) is a standard of care with a pathologic complete response (pCR) rate of 20%. We evaluated a novel combination of trifluridine/tipiracil with oxaliplatin as induction chemotherapy (IC) followed by CRT.

Methods:

We enrolled patients with potentially resectable localized EGAC (T3, T4aN0, or node‐positive disease) in this open‐label, single‐arm, multicenter, Phase II trial between January 2020 and October 2022. Patients received three cycles of IC with trifluridine/tipiracil and oxaliplatin and then underwent concurrent CRT with weekly carboplatin and paclitaxel followed by surgery. The primary objective was to evaluate the pCR rate. The secondary objectives were to evaluate 2‐year progression‐free survival (PFS), 2‐year overall survival (OS), and toxicities. Circulating tumor DNA (ctDNA) was measured at prespecified intervals to assess its correlation with clinical outcomes.

Results:

Of the 22 enrolled patients, 19 (86.4%) were male and 20 (90.9%) were Caucasian. The median age was 61 years, and 12 (54.5%) had their primary disease at the gastroesophageal junction. Twenty (90.9%) patients had T3 disease, and 15 (68.2%) had node‐positive disease. Only two patients had pCRs, and an additional five had near pCRs. Since we could not meet our predefined pCR rate at the interim analysis, the study was closed. After a median follow‐up of 15.8 months, 2‐year OS and PFS were 43% and 41%, respectively. ctDNA clearance was associated with a significantly higher OS rate (p = 0.012) and PFS rate (p = 0.008). Nausea (59.1%) and fatigue (59.1%) were common treatment‐related adverse events (AEs); nine (40.9%) patients had Grade 3 or higher AEs.

Conclusion:

IC with trifluridine/tipiracil and oxaliplatin followed by CRT did not improve pCR rate in resectable EGAC compared to pCR from previous reports with CRT alone. We found a correlation between ctDNA clearance and improved survival, which merits further investigation.

Clinical Trial Information:

NCT04097028.

2025-03-10·ONCOLOGIST

Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer: safety analysis of FRESCO-2

Article

作者: Yao, James ; Pallai, Rajash ; Eng, Cathy ; Sartore-Bianchi, Andrea ; Sobrero, Alberto ; Dasari, Arvind ; Tomasek, Jiri ; Garcia-Carbonero, Rocio ; Satoh, Taroh ; Yang, Zhao ; Schelman, William ; Yoshino, Takayuki ; Tabernero, Josep ; Kocsis, Judit ; Randrian, Violaine ; Garcia-Alfonso, Pilar ; Chong, Geoff ; Elez, Elena ; Guevara, Ferdinand ; Lonardi, Sara ; Gracian, Antonio Cubillo

Abstract:

Background:

Fruquintinib is a highly selective, oral inhibitor of all 3 VEGF receptors. The global, randomized, double-blind phase 3 FRESCO-2 trial (NCT04322539) met its primary endpoint demonstrating significantly improved overall survival in patients with refractory metastatic colorectal cancer (mCRC) who received fruquintinib plus best supportive care (BSC) versus placebo plus BSC. Here we report detailed safety data from FRESCO-2 including an analysis of treatment-related adverse events of special interest (AESIs).

Patients and methods:

Patients with mCRC eligible for FRESCO-2 had received all standard chemotherapies and prior anti-VEGF and anti-EGFR therapies if indicated, and displayed progression on, or intolerance to, TAS-102 and/or regorafenib. Prespecified AESIs based on VEGFR tyrosine kinase inhibitor drug classes were evaluated.

Results:

Incidences of treatment-related AESIs were 64.9% with fruquintinib + BSC versus 23.0% with placebo + BSC. The most frequent all-grade treatment-related AESIs for fruquintinib were hypertension (28.9%; grade ≥3 10.7%), palmar-plantar erythrodysesthesia syndrome/hand-foot skin reaction (PPE 18.6%; grade ≥3 6.1%), and hypothyroidism (15.6%; grade ≥3 0.4%). Dose reductions due to treatment-related AESIs were reported in 10.3% of patients who received fruquintinib + BSC versus 0.4% with placebo + BSC. The most common treatment-related AESIs resulting in dose reduction for fruquintinib were PPE syndrome (5.0%), hypertension (2.9%), and proteinuria (1.3%). Overall, 5.9% versus 0.9% had treatment-related AESIs resulting in study drug discontinuation.

Conclusion:

Fruquintinib + BSC demonstrated a predictable and manageable safety profile in pretreated patients with mCRC and is a novel oral treatment option that prolongs survival and enriches the continuum of care in this population.

2025-02-01·EClinicalMedicine

Trifluridine-tipiracil in previously treated patients with oestrogen receptor-positive, HER2-negative metastatic breast cancer (BOOG 2019-01 TIBET trial): a single-arm, multicentre, phase 2 trial

Article

作者: Nieboer, Peter ; Guchelaar, Niels A D ; Bijlsma, Rhodé M ; Heijns, Joan B ; Hamming, Lisanne ; de Boer, Maaike ; van Bekkum, Marlies L ; Bos, Monique E M M ; van den Berg, Susan M ; Beelen, Karin J ; Mathijssen, Ron H J ; Kessels, Lonneke W ; van Rosmalen, Mandy M ; Hoop, Esther Oomen-de ; Vriens, Birgit E P J

Background:

Effective later-line chemotherapy treatment options are scarce for patients with metastatic breast cancer (MBC). Trifluridine-tipiracil has shown survival benefit in heavily pre-treated patients with metastatic colorectal and in gastric cancer refractory to a fluoropyrimidine. This study aimed to investigate the efficacy of trifluridine-tipiracil in a Western population of previously treated patients with oestrogen receptor (ER+), HER2- MBC to facilitate further optimization of this treatment strategy.

Methods:

Adult patients at least 18 years old diagnosed with hormone receptor positive, HER2- receptor negative MBC with a performance status of 0 or 1 who have been treated with capecitabine in the metastatic setting and up to two other lines of chemotherapy, including a taxane, were enrolled in this single-arm, multicentre, phase 2 study in the Netherlands. The participants received trifluridine-tipiracil 35 mg/m² orally twice a day on days 1-5 and days 8-12 during a 28-day cycle until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the disease control rate (DCR) at 8 weeks, defined as the percentage of patients that had stable disease, partial response or complete response according to RECIST 1.1, in all patients that received at least one dose of trifluridine-tipiracil and met the key eligibility criteria defined a priori. Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and quality of life and were performed in all patients that received at least one dose of trifluridine-tipiracil. The primary endpoint was considered met, justifying further research of this treatment regimen, if the lower boundary of the 80% confidence interval (CI) exceeded 30%. The study was registered within ClinicalTrials.gov (NCT04489173) and is closed for inclusion.

Findings:

Fifty female patients were enrolled from September 2020 to July 2023, with a median of 3 (IQR, 2-3) previous endocrine therapy lines and 2 (IQR, 2-3) chemotherapy lines for MBC. The DCR rate at 8 weeks was 64.0% (n = 32, 95% CI: 50.1-75.9%; 80% CI: 55.0-72.1%), thereby meeting the primary endpoint of this study. At data cutoff (January 8, 2024), the median follow-up time was 18.2 months (IQR, 13.1-25.1 months). The median PFS was 5.4 months (95% CI: 2.0-7.2 months) and the median OS 14.0 months (95% CI: 8.8-17.8 months). The safety profile of trifluridine-tipiracil aligned with expected toxicities and included leukopenia (n = 36, 69%), neutropenia (n = 43, 83%), and fatigue (n = 43, 83%). The most common grade 3-4 AEs were primarily haematological disorders and included neutropenia (n = 38, 73%), leukopenia (n = 15, 29%) and anaemia (n = 6, 12%). The most common SAEs (any grade) with a possible relationship with trifluridine-tipiracil included anaemia (n = 2) and vomiting (n = 2). No treatment-related deaths occurred. Quality of life scores remained stable throughout the treatment.

Interpretation:

Trifluridine-tipiracil demonstrated promising efficacy in heavily pre-treated patients with MBC, despite prior exposure to a fluoropyrimidine. Clinically, this suggests that trifluridine-tipiracil holds potential as a viable oral later-line treatment option with a manageable toxicity profile while maintaining quality of life. Preparations for a phase 3 trial are underway.

Funding:

Servier, France.

203

项与曲氟尿苷替匹嘧啶相关的新闻（医药）

2025-04-24

·PRNewswire

Oncolytics Biotech® to Showcase New Pancreatic Cancer Data at ASCO Highlighting Pelareorep's Tumor-Fighting Mechanism of Action

ASCO data expected to highlight how pelareorep activates immune responses in pancreatic cancer patients Ongoing updates support potential of pelareorep combination therapies in one of the deadliest and hardest-to-treat cancers SAN DIEGO and CALGARY, AB, April 24, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, will present new data from Cohort 1 of the GOBLET study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago May 30-June 3, 2025 demonstrating pelareorep's anti-tumor activity in pancreatic ductal adenocarcinoma (PDAC) - the most common form of pancreatic cancer characterized by its poor prognosis and limited treatment options. "Pelareorep continues to deliver encouraging results in pancreatic cancer, where few effective treatments exist," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "In multiple studies, pelareorep has repeatedly demonstrated its ability to engage the immune system to attack pancreatic cancer tumors, which has the potential to improve outcomes for patients battling this difficult-to-treat cancer." Abstract Number: 2562 Title: Role of pelareorep in activating anti-tumor immunity in PDAC. Presentation Type: Poster Session Title: Developmental Therapeutics – Immunotherapy Session Date and Time: June 2, 2025, 1:30 - 4:30 p.m. CT Abstracts will be published on the ASCO website at 5:00 p.m. ET on May 22, 2025. About GOBLET The GOBLET ( Gastrointestinal tum Ors exploring the treatment com Binations with the oncolytic reovirus pe Lar Eorep and an Ti-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with modified FOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our belief that there are multiple clinical and regulatory options for bringing pelareorep to patients; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 [email protected] Media Contact for Oncolytics Michael Rubenstein LifeSci Communications [email protected] Logo - SOURCE Oncolytics Biotech® Inc. 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临床结果免疫疗法ASCO会议快速通道临床2期

2025-04-24

·oncolyticsbiotech.com

Oncolytics Biotech® to Showcase New Pancreatic Cancer Data at ASCO Highlighting Pelareorep’s Tumor-Fighting Mechanism of Action

ASCO data expected to highlight how pelareorep activates immune responses in pancreatic cancer patients Ongoing updates support potential of pelareorep combination therapies in one of the deadliest and hardest-to-treat cancers SAN DIEGO and CALGARY, AB, April 24, 2025 /PRNewswire/ — Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, will present new data from Cohort 1 of the GOBLET study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago May 30-June 3, 2025 demonstrating pelareorep’s anti-tumor activity in pancreatic ductal adenocarcinoma (PDAC) – the most common form of pancreatic cancer characterized by its poor prognosis and limited treatment options. “Pelareorep continues to deliver encouraging results in pancreatic cancer, where few effective treatments exist,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. “In multiple studies, pelareorep has repeatedly demonstrated its ability to engage the immune system to attack pancreatic cancer tumors, which has the potential to improve outcomes for patients battling this difficult-to-treat cancer.” Abstract Number: 2562Title: Role of pelareorep in activating anti-tumor immunity in PDAC.Presentation Type: PosterSession Title: Developmental Therapeutics – ImmunotherapySession Date and Time: June 2, 2025, 1:30 – 4:30 p.m. CT Abstracts will be published on the ASCO website at 5:00 p.m. ET on May 22, 2025. About GOBLET The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with modified FOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our belief that there are multiple clinical and regulatory options for bringing pelareorep to patients; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon PattonDirector of IR & Communicationjpatton@oncolytics.ca Investor Relations for Oncolytics Mike MoyerLifeSci Advisors+1-617-308-4306mmoyer@lifesciadvisors.com Media Contact for Oncolytics Michael RubensteinLifeSci Communicationsmrubenstein@lifescicomms.com Logo – https://mma.prnewswire.com/media/2408622/5284957/Oncolytics_Biotech_Inc_Logo.jpg SOURCE Oncolytics Biotech® Inc.

临床结果免疫疗法ASCO会议快速通道临床2期

2025-04-20

·信狐药迅

上海信致首个血友病B基因治疗药物BBM-H901获批上市| 新获批(4.14-4.20）

每周药品注册获批数据，分门别类呈现，一目了然。(4.14-4.20）新药上市申请药品名称企业注册分类受理号BBM-H901注射液上海信致医药科技有限公司1CXSS2400078新药临床申请药品名称企业注册分类受理号HS-10529片江苏豪森药业集团有限公司1CXHL2500182HS-10529片江苏豪森药业集团有限公司1CXHL2500181HS-20118片江苏豪森药业集团有限公司1CXHL2500153HS-20118片江苏豪森药业集团有限公司1CXHL2500152HS-20118片江苏豪森药业集团有限公司1CXHL2500151双环醇缓释片海南广升誉制药有限公司2.2CXHL2500119MIRSRT缓释片吉林天衡药业有限公司2.2CXHL2500098MIRSRT缓释片吉林天衡药业有限公司2.2CXHL2500097MIRSRT缓释片吉林天衡药业有限公司2.2CXHL2500096普卢格列汀二甲双胍缓释片(Ⅱ)石药集团欧意药业有限公司2.3CXHL2500187普卢格列汀二甲双胍缓释片(Ⅰ)石药集团欧意药业有限公司2.3CXHL2500185TAP-1503 乳膏上海泽德曼医药科技有限公司2.4CXHL2500154重组呼吸道合胞病毒疫苗(CHO细胞)北京吉诺卫生物科技有限公司1.2CXSL240093120价肺炎球菌多糖结合疫苗云南沃森生物技术股份有限公司2.2CXSL2500061注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500144IAH0968盛禾(中国)生物制药有限公司1CXSL2500141CM326注射液上海津曼特生物科技有限公司1CXSL2500133CM326注射液上海津曼特生物科技有限公司1CXSL2500132IBI3020信达生物医药科技(杭州)有限公司1CXSL2500123HWS116注射液武汉人福创新药物研发中心有限公司1CXSL2500125SHR-4849注射液苏州盛迪亚生物医药有限公司1CXSL2500111注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500120注射用LBL-024南京维立志博生物科技股份有限公司1CXSL2500112LBL-007注射液南京维立志博生物科技股份有限公司1CXSL2500113注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500116注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500118注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500115注射用BL-M09D1成都百利多特生物药业有限责任公司1CXSL2500103注射用KH815成都康弘生物科技有限公司1CXSL2500104XS411细胞注射液士泽生物医药(苏州)有限公司1CXSL2500066IBR854细胞注射液英百瑞(杭州)生物医药有限公司1CXSL2500064异体人再生胰岛注射液(E-islet 01)智新浩正(上海)医药科技有限公司1CXSL2500063XS228细胞注射液士泽生物医药(苏州)有限公司1CXSL2500055BBM-D101注射液信中医药科技(北京)有限公司1CXSL2500060靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液上海邦耀生物科技有限公司1CXSL2500053注射用卡瑞利珠单抗苏州盛迪亚生物医药有限公司2.2CXSL2500135SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500110注射用重组人TNK组织型纤溶酶原激活剂石药集团明复乐药业(广州)有限公司2.2CXSL2500054仿制药申请药品名称企业注册分类受理号叶酸注射液北京布霖生物科技有限公司3CYHS2303593叶酸注射液北京布霖生物科技有限公司3CYHS2303592叶酸注射液华夏生生药业(北京)有限公司3CYHS2303354叶酸注射液华夏生生药业(北京)有限公司3CYHS2303353吲哚布芬片山西德元堂药业有限公司3CYHS2303321氯化钾颗粒贵州瑞和制药有限公司3CYHS2303245氯化钾颗粒贵州瑞和制药有限公司3CYHS2303244磷酸奥司他韦干混悬剂宏越科技(湖州)有限公司3CYHS2303054法莫替丁注射液海南慧通生物医药科技有限公司3CYHS2303043法莫替丁注射液成都欣捷高新技术开发股份有限公司3CYHS2303025磷酸奥司他韦干混悬剂石药集团中诺药业(石家庄)有限公司3CYHS2302914氟哌啶醇注射液安徽长江药业有限公司3CYHS2302850地塞米松磷酸钠注射液四川美大康华康药业有限公司3CYHS2302827磷酸奥司他韦干混悬剂济南同路医药科技发展有限公司3CYHS2302681盐酸拉贝洛尔氯化钠注射液江苏迪赛诺制药有限公司3CYHS2302560巯嘌呤片浙江诚意药业股份有限公司3CYHS2302394盐酸丙卡特罗片江苏万高药业股份有限公司3CYHS2302320硫酸镁注射液福建天泉药业股份有限公司3CYHS2302240硫酸镁注射液福建天泉药业股份有限公司3CYHS2302238重酒石酸间羟胺注射液湖南华纳大药厂股份有限公司3CYHS2302186硝酸甘油注射液中山万汉制药有限公司3CYHS2302118硝酸甘油注射液中山万汉制药有限公司3CYHS2302117西吡氯铵含片成都倍特药业股份有限公司3CYHS2301984地奈德乳膏江苏知原药业股份有限公司3CYHS2301899氨溴特罗口服溶液天大药业(珠海)有限公司3CYHS2301803注射用苯唑西林钠广东金城金素制药有限公司3CYHS2301673盐酸伐地那非口腔崩解片安徽四环科宝制药有限公司3CYHS2301661氯化钾颗粒济川药业集团有限公司3CYHS2301588氯化钾颗粒济川药业集团有限公司3CYHS2301587氨溴特罗口服溶液合肥国高药业有限公司3CYHS2300951氨溴特罗口服溶液合肥国高药业有限公司3CYHS2300950富马酸福莫特罗吸入溶液海南斯达制药有限公司3CYHS2300585卡络磺钠注射液中润药业有限公司3CYHS2300270卡络磺钠注射液中润药业有限公司3CYHS2300269氧(液态)河北舜广联合气体有限公司4CYHS2401856注射用头孢比罗酯钠深圳华润九新药业有限公司4CYHS2401317地夸磷索钠滴眼液重庆苯立方医药科技有限公司4CYHS2400789普伐他汀钠片浙江诺得药业有限公司4CYHS2400709阿戈美拉汀片安徽艾立德制药有限公司4CYHS2400657左氧氟沙星滴眼液江苏万高药业股份有限公司4CYHS2400357盐酸罗匹尼罗缓释片植恩生物技术股份有限公司4CYHS2400315吲达帕胺缓释片南京易亨制药有限公司4CYHS2400061达格列净二甲双胍缓释片(I)南京方生和医药科技有限公司4CYHS2303581罗沙司他胶囊山东新时代药业有限公司4CYHS2303539罗沙司他胶囊山东新时代药业有限公司4CYHS2303538熊去氧胆酸胶囊湖南醇健制药科技有限公司4CYHS2303487地氯雷他定片四川依科制药有限公司4CYHS2303388丙酸氟替卡松乳膏江苏知原药业股份有限公司4CYHS2303335盐酸哌甲酯缓释片合肥立方制药股份有限公司4CYHS2303218中/长链脂肪乳注射液(C6-24)四川科伦药业股份有限公司4CYHS2303032曲氟尿苷替匹嘧啶片山东新时代药业有限公司4CYHS2302922曲氟尿苷替匹嘧啶片山东新时代药业有限公司4CYHS2302921洛索洛芬钠凝胶贴膏哈尔滨力强药业有限责任公司4CYHS2302637阿仑膦酸钠片菲洋生物科技(吉林)有限公司4CYHS2302539泊沙康唑注射液浙江海正药业股份有限公司4CYHS2302492唑来膦酸注射液山东百诺医药股份有限公司4CYHS2302415注射用厄他培南广东金城金素制药有限公司4CYHS2301909蒙脱石混悬液成都归合科技有限公司4CYHS2300052铜[64Cu]氧奥曲肽注射液江苏华益科技有限公司3CYHL2500038阿瑞匹坦注射液山东百诺医药股份有限公司3CYHL2500021布立西坦口服溶液江西科睿药业有限公司3CYHL2500019琥珀酰明胶电解质醋酸钠注射液内蒙古白医制药股份有限公司4CYHL2500020地舒单抗注射液华兰基因工程(河南)有限公司3.3CXSL2500127进口申请药品名称企业注册分类受理号佩玛贝特片Kowa Company, Ltd.5.1JXHS2300098九价人乳头瘤病毒疫苗(酿酒酵母)Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.3.1JXSS2300076九价人乳头瘤病毒疫苗(酿酒酵母)Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.3.1JXSS2300075注射用厄他培南Gland Pharma Limited5.2JYHS2300082注射用硫酸多黏菌素BXellia Pharmaceuticals ApS5.2JYHS2101056国;JYHS2101056Bexicaserin口服溶液Longboard Pharmaceuticals, Inc.1JXHL2500013放射性药物镓[68Ga]oxodotreotide注射液配制用药盒Novartis Pharma AG2.4JXHL2500020Tezepelumab注射液AstraZeneca AB2.2JXSL2500021中药相关申请药品名称企业注册分类受理号反流清颗粒江西银涛药业股份有限公司1.1CXZL2500005吾斯提库都斯颗粒和田维吾尔药业股份有限公司1.1CXZL2500004三芪颗粒广西中恒创新医药研究有限公司1.1CXZL2500003温经汤颗粒国药集团德众(佛山)药业有限公司3.1CXZS2300022注：橙色字体部分结论为不批准或收到通知件；

疫苗基因疗法上市批准核酸药物

100 项与曲氟尿苷替匹嘧啶相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	曲氟尿苷替匹嘧啶	L01BC	DB08937

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HER2阳性胃癌	韩国	Jeil Pharmaceutical Co., Ltd.	2019-10-17
转移性胃癌	澳大利亚	SERVIER LABORATORIES (AUST.) PTY. LTD.	2017-05-23
转移性胃食管结合部腺癌	澳大利亚	SERVIER LABORATORIES (AUST.) PTY. LTD.	2017-05-23
胃食管交界处腺癌	欧盟	Les Laboratoires Servier SAS	2016-04-25
胃食管交界处腺癌	冰岛	Les Laboratoires Servier SAS	2016-04-25
胃食管交界处腺癌	列支敦士登	Les Laboratoires Servier SAS	2016-04-25
胃食管交界处腺癌	挪威	Les Laboratoires Servier SAS	2016-04-25
转移性结直肠癌	美国	Taiho Oncology, Inc.	2015-09-22
结直肠癌	日本	Taiho Pharmaceutical Co., Ltd.	2014-03-24
胃癌	日本	Taiho Pharmaceutical Co., Ltd.	2014-03-24

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
RAS/BRAF基因野生型结直肠癌	临床3期	美国	Adir SRL	2022-04-21
RAS/BRAF基因野生型结直肠癌	临床3期	日本	Adir SRL	2022-04-21
RAS/BRAF基因野生型结直肠癌	临床3期	比利时	Adir SRL	2022-04-21
RAS/BRAF基因野生型结直肠癌	临床3期	丹麦	Adir SRL	2022-04-21
RAS/BRAF基因野生型结直肠癌	临床3期	芬兰	Adir SRL	2022-04-21
RAS/BRAF基因野生型结直肠癌	临床3期	匈牙利	Adir SRL	2022-04-21
实体瘤	临床3期	法国	Servier Group	2022-01-30
大肠腺癌	临床2期	法国	Les Laboratoires Servier SAS	2025-03-21
双氢嘧啶脱氢酶缺乏	临床2期	法国	Les Laboratoires Servier SAS	2025-03-21
胃食管交界处癌	临床2期	法国	Les Laboratoires Servier SAS	2025-03-21

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04097028 (Pubmed \| Cancer Med)	临床2期	胃食管交界处腺癌 circulating tumor DNA (ctDNA)	22	Trifluridine/Tipiracil and Oxaliplatin	醖觸憲夢選簾鑰餘鬱淵(網顧憲築蓋鏇選鏇壓顧) = 醖範鑰簾範壓選構獵觸選艱繭壓遞醖鹽廠憲選 (觸淵選獵襯窪夢鬱顧廠 ) 更多	不佳	2025-04-01
NCT04489173 (BOOG 2019-01 TIBET trial, Pubmed \| EClinicalMedicine)	临床2期	转移性HER2阴性乳腺癌 oestrogen receptor-positive \| HER2-negative	50	Trifluridine-tipiracil 35 mg/m2	壓糧壓醖艱壓齋蓋繭壓(齋網壓獵糧鏇艱鑰構鑰) = 壓膚顧衊齋鑰網衊築鏇選築網襯衊廠醖願齋鹽 (願簾積積蓋醖選夢願膚, 50.1 ~ 75.9) 更多	积极	2025-02-01
ASCO_GI2025 人工标引	N/A	转移性结直肠癌	639	trifluridine-tipiracil	鹽淵夢築鹽壓積壓網窪(窪糧網繭淵窪觸衊願窪) = 網顧憲鏇構壓簾蓋範鏇製齋鬱網繭衊繭齋餘蓋 (製膚遞襯選鑰鹹窪選鑰, 5.7 ~ 6.9) 更多	积极	2025-01-23
				trifluridine-tipiracil+bevacizumab	鹽淵夢築鹽壓積壓網窪(窪糧網繭淵窪觸衊願窪) = 襯選製廠選壓鹹淵積鏇製齋鬱網繭衊繭齋餘蓋 (製膚遞襯選鑰鹹窪選鑰, 7.8 ~ 16.0) 更多
ASCO_GI2025 人工标引	N/A	转移性结直肠癌	3,680	trifluridine-tipiracil	艱襯構蓋積築糧鹽願鹹(廠鏇願壓廠製簾簾糧襯) = 鏇夢憲艱鬱選齋繭鏇築鑰醖窪廠餘選糧簾遞觸 (築餘淵選夢遞遞願獵網, 6.1 ~ 6.6) 更多	积极	2025-01-23
				trifluridine-tipiracil+bevacizumab	艱襯構蓋積築糧鹽願鹹(廠鏇願壓廠製簾簾糧襯) = 構膚鬱鏇餘鬱廠艱壓齋鑰醖窪廠餘選糧簾遞觸 (築餘淵選夢遞遞願獵網, 8.0 ~ 10.1) 更多
NCT04457297 (ALTAIR, ASCO_GI2025) 人工标引	临床3期	结直肠癌	243	Trifluridine/Tipiracil (FTD/TPI)	鹽廠築選襯夢選醖簾鑰(鬱憲壓襯艱壓構餘鑰選) = 鹽構鑰襯繭築構壓淵淵鬱範衊範簾衊醖構鏇繭 (觸餘齋廠築鏇築鬱願製 ) 未达到更多	不佳	2025-01-23
				Placebo	鹽廠築選襯夢選醖簾鑰(鬱憲壓襯艱壓構餘鑰選) = 鏇觸齋遞壓構簾淵願夢鬱範衊範簾衊醖構鏇繭 (觸餘齋廠築鏇築鬱願製 ) 未达到更多
NCT02848079 (ASCO_GI2025)	临床1/2期	结直肠癌 RAS mutated	54	TAS102 with oxaliplatin (TASOX)	壓選鬱憲壓積網壓簾餘(憲壓醖顧鏇餘醖齋艱觸) = 膚齋願壓顧鹽製壓憲鑰餘醖鏇廠網壓範顧醖範 (鹽衊鏇網製壓鏇夢網蓋 ) 更多	积极	2025-01-23
ChiCTR2300078241 (ASCO_GI2025)	临床2期	转移性结直肠癌三线 RAS mutations	26	Fruquintinib	憲鏇簾製鬱窪蓋範憲鹽(齋選製繭鹽膚蓋醖願艱) = 遞選襯繭蓋觸構蓋膚製衊壓壓願觸觸壓鹹製獵 (蓋選衊築蓋鑰齋糧選積 ) 更多	积极	2025-01-23
				TAS-102	憲鏇簾製鬱窪蓋範憲鹽(齋選製繭鹽膚蓋醖願艱) = 襯鬱顧顧範齋範選築鹽衊壓壓願觸觸壓鹹製獵 (蓋選衊築蓋鑰齋糧選積 ) 更多
BeTAS trial (ASCO_GI2025)	N/A	转移性结直肠癌三线 RAS mutations	208	Trifluridine/tipiracil and bevacizumab (FTD/TPI+BEV)	憲鏇壓醖範壓蓋鏇網艱(夢獵襯繭構壓齋壓獵築) = 鏇範淵遞廠範繭選壓選簾觸齋遞廠壓鹹齋遞艱 (範繭憲觸築簾鏇鑰醖構 ) 更多	积极	2025-01-23
NCT06202001 (ASCO_GI2025)	临床2期	转移性结直肠癌二线	60	Trifluridine/tipiracil (TAS-102) + Irinotecan + Bevacizumab	鏇憲餘顧構範繭鬱壓觸(壓餘憲顧壓鬱鹽廠蓋鬱) = 淵鹹蓋淵蓋鹹選鹽鹹繭選簾選襯鹽糧構糧鬱鏇 (醖製網衊膚願願窪壓範 ) 更多	积极	2025-01-23
ASCO_GI2025	N/A	结直肠癌三线	75	TAS-102	築糧廠餘糧鹽獵襯鑰觸(鑰壓觸築構齋網觸築醖) = 鏇鏇築選簾鹽網願積壓遞廠夢網顧憲願簾鏇鹽 (觸蓋壓鏇築夢壓壓壓餘 )	不佳	2025-01-23
				Chemotherapy rechallenge	築糧廠餘糧鹽獵襯鑰觸(鑰壓觸築構齋網觸築醖) = 觸製願糧鏇繭壓淵憲壓遞廠夢網顧憲願簾鏇鹽 (觸蓋壓鏇築夢壓壓壓餘 )