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

Start Date01 May 2025

Sponsor / Collaborator

Delcath Systems, Inc.

NCT06245356

/ Not yet recruitingPhase 2IIT

TRIFLUOX-DP: Safety of Trifluridine/Tipiracil as Replacement of Fluoropyrimidines (5-fluorouracil and Capecitabine) Based Chemotherapy as First Line Metastatic Colorectal or Gastroesophageal Cancer Regimens in Patients With Dihydropyrimidine Dehydrogenase Deficiency: a Phase II Trial

The goal of this clinical trial is to test the safety of the trifluridine/tipiracil as replacement of fluoropyrimidines based chemotherapy as first line metastatic colorectal or gastroesophageal cancer regimens in patients with dihydropyrimidine dehydrogenase (DPD) deficiency.
The main questions it aims to answer are:
* Is this alternative chemotherapy option a better option in term of safety for this type of patients?
* Does the combination of treatments improves the overall safety?
* Does the combination of treatments improves the progression-free survival, overall survival, objective response rate and disease control rate?
* Does the combination of treatment have an effect on quality of life?
Participants will:
* Receive the trifluridine/tipiracil with oxaliplatin every 14 days, associated with:
* Panitumumab or bevacizumab for colorectal adenocarcinomas
* Nivolumab or trastuzumab for gastroesophageal adenocarcinomas.
* Have a CT-Scan every 2 months until disease progression
* Complete Health-related quality of life questionnaire every 2 months for a maximum of 6 months
* Participate to the optional translational research: Blood samples fo DPYD genotyping and pharmacokinetic analysis

Start Date31 Jan 2025

Sponsor / Collaborator

UNICANCER

[+1]

NCT06764680

/ Not yet recruitingPhase 2IIT

Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab With/without Involved Lesions Irradiation As 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer: a Phase 2, Double Cohort Clinical Trial

The current phase 2, double cohort clinical trial was designed to determine the effectiveness of Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab with/without involved lesions irradiation as 3rd- or later-line therapy for advanced MSS/pMMR colorectal cancer.

Start Date31 Dec 2024

Sponsor / Collaborator

Sun Yat-Sen University

100 Clinical Results associated with Tipiracil Hydrochloride/Trifluridine

100 Translational Medicine associated with Tipiracil Hydrochloride/Trifluridine

100 Patents (Medical) associated with Tipiracil Hydrochloride/Trifluridine

366

Literatures (Medical) associated with Tipiracil Hydrochloride/Trifluridine

14 Dec 2024·BRITISH JOURNAL OF CANCER

Phase II Study of Irinotecan, Trifluridine/tipiracil (TAS-102) plus Bevacizumab as a Later-line Therapy for Patients with Metastatic Colorectal Cancer (mCRC): a prospective single-center explorative study

Article

Author: Bi, Deying ; Yang, Wenwei ; Yang, Tingting ; Liu, Na ; Wu, Guifu ; Sun, Yongkun ; Li, Baoqi

Abstract:

Purpose:

To explore the efficacy and safety of the combination of irinotecan, trifluridine/tipiracil (TAS-102), and bevacizumab in a later‐line setting for metastatic colorectal cancer (mCRC) patients.

Patients and methods:

This was a single-center, phase II trial. The mCRC patients who are refractory to standard first-line and second-line treatment are eligible. Patients who previously received irinotecan while progressing during maintenance therapy are also eligible. The primary endpoint was the objective response rate (ORR).

Results:

Between August 1, 2022, and September 30, 2023, 35 patients were enrolled, and 31 of them were evaluable for efficacy. The ORR was 25.8% (8/31), and the disease control rate (DCR) was 93.5% (29/31). As of April 30, 2024, the median progression-free survival (PFS) was 9.2 months (95% CI 6.285-12.115), whereas the median overall survival (OS) was not reached with the 1-year OS rate of 73.5%. The most common grade 3/4 treatment-related adverse events were neutropenia (34.3%), anemia (17.1%), and thrombocytopenia (8.6%).

Conclusion:

Irinotecan, TAS-102 plus bevacizumab regimen preliminarily demonstrated promising efficacy with tolerable toxicity for mCRC patients as later‐line treatment. This regimen warrants further exploration in refractory mCRC patients.

06 Dec 2024·ONCOLOGIST

Association between sidedness and survival among chemotherapy refractory metastatic colorectal cancer patients treated with trifluridine/tipiracil or regorafenib

Article

Author: Hsieh, Meng-Che ; Liu, Kuang-Wen ; Rau, Kun-Ming ; Hsiao, Kai-Yuan ; Chang, Wei-Shan ; Liang, Hao-Yun ; Chen, Hsin-Pao ; Shia, Ben-Chang

Abstract:

Background:

The impact of sidedness on survival of later-line treatment in patients with metastatic colorectal cancer (mCRC) is undetermined. This study aimed to investigate the association between sidedness and survival among chemotherapy refractory patients with mCRC treated with trifluridine/tipiracil (TAS-102) or regorafenib or both.

Patients and Methods:

Patients with mCRC treated with TAS-102 or regorafenib between 2015 and 2020 was retrospectively collected. Patients were stratified into TAS-102 first and regorafenib first, then subdivided into TAS-102 followed by regorafenib (T-R) and regorafenib followed by TAS-102 (R-T) groups. The oncologic outcomes were presented with time-to-treatment failure (TTF) and overall survival (OS).

Results:

After matching, 376 TAS-102 patients and 376 regorafenib patients were included for outcomes comparison. TTF had insignificant differences while OS was significantly different between TAS-102 and regorafenib groups. Median TTF and OS were 1.9 months versus 2.0 months (P = .701) and 9.1 months versus 7.0 months (P = .008) in TAS-102 and regorafenib, respectively. The OS benefits were consistent regardless primary tumor location. Subgroup analysis with 174 T-R patients and 174 R-T patients was investigated for treatment sequences. TTF and OS had significant differences in both groups. Median TTF and OS were 8.5 months versus 6.3 months (P = .001) and 14.4 months versus 12.6 months (P = .035) in T-R and R-T groups, respectively. The TTF and OS benefits were persisted regardless primary tumor location.

Conclusion:

TAS-102 first provided a better survival benefit in chemotherapy refractory patients with mCRC across all sidedness. Further prospective studies are warranted to validate our conclusions.

01 Dec 2024·Clinical Colorectal Cancer

Impact of Treatment With Trifluridine/Tipiracil in Combination With Bevacizumab on Health-Related Quality of Life and Performance Status in Refractory Metastatic Colorectal Cancer: An Analysis of the Phase III SUNLIGHT Trial

Article

Author: Soler, Gemma ; Fakih, Marwan ; Taieb, Julien ; Roby, Lucas ; Ciardiello, Fortunato ; Barboux, Valentine ; Prager, Gerald W ; Tabernero, Josep ; Amellal, Nadia ; Van Cutsem, Eric ; Calleja, Elizabeth

BACKGROUND:

The efficacy of trifluridine/tipiracil (FTD/TPI) + bevacizumab compared to FTD/TPI for treatment of refractory metastatic colorectal cancer (mCRC) was demonstrated in the SUNLIGHT trial. This analysis of SUNLIGHT investigated the impact of treatment with FTD/TPI + bevacizumab on patient quality of life (QoL) and Eastern Cooperative Oncology Group performance status (ECOG PS).

METHODS:

Questionnaires (EORTC QLQ-C30 and EQ-5D-5L) and ECOG PS assessments were conducted at baseline and on Day 1 of each treatment cycle. Time to definitive deterioration (TTDD) of QoL and time to ECOG PS worsening between treatment arms was assessed. A repeated-measures mixed-effects model was used to compare changes in QoL and ECOG PS from baseline. Kaplan-Meier and Cox regression methods were used to assess TTDD of QoL, time to ECOG PS worsening to ≥ 2, and overall survival (OS) and progression-free survival (PFS) in patients maintaining an ECOG PS of 0-1.

RESULTS:

Both treatment arms showed similar QoL scores from baseline to cycle 6, with no clinically relevant change over time. Patients receiving FTD/TPI + bevacizumab had a longer TTDD of QoL than patients receiving FTD/TPI, as well as longer time to ECOG PS worsening. In patients with maintained ECOG PS, median OS and PFS was prolonged in the FTD/TPI + bevacizumab arm compared to the FTD/TPI arm.

CONCLUSION:

This analysis of SUNLIGHT showed that patients treated with FTD/TPI + bevacizumab had no clinically relevant changes in QoL, and prolonged TTDD and time to ECOG PS worsening, compared to patients treated with FTD/TPI.

101

News (Medical) associated with Tipiracil Hydrochloride/Trifluridine

22 Jan 2025

·www.prnewswire.com

Oncolytics Biotech® to Present Compelling New Efficacy and Safety Data in Anal and Pancreatic Cancers at 2025 ASCO GI Symposium

Pelareorep combination therapy shows continued meaningful improvement over checkpoint inhibitors alone in anal cancer patients Pelareorep-based therapy demonstrates strong safety profile with new chemotherapy regimen in pancreatic cancer patients SAN DIEGO and CALGARY, AB, Jan. 22, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today provided details from the abstracts featuring pelareorep that are being presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025. Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech, commented, "The posters that will be presented at the symposium later this week continue to show pelareorep's compelling potential in gastrointestinal cancers. In relapsed anal cancer, the efficacy signal that was initially reported continues to outperform historical control trials with the inclusion of additional patients. Importantly, the complete response we observed previously continued beyond the 12 months initially reported. Together, these results point to a clinically meaningful synergy between pelareorep and checkpoint inhibitors like atezolizumab. In pancreatic cancer, pelareorep previously demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel and atezolizumab. Our new safety data indicate its ability to also be combined with modified FOLFIRINOX, thus expanding its potential to benefit patients with metastatic pancreatic cancer. We will continue to provide updates on the safety and efficacy of pelareorep-based combination therapy from these cohorts as they become available." "I am quite pleased by these recent updates from the GOBLET study as they continue to provide potential new treatment options for patients in need of alternatives while maintaining a manageable safety profile," said Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "I've been especially impressed with the ability of pelareorep-based therapies to work across multiple challenging cancer indications and with multiple standards of care, including chemotherapy and checkpoint inhibitors, so I look forward to additional data readouts that can help improve the treatment paradigm." Abstract Number: 6 Title: GOBLET platform study: Preliminary safety and tumor response results for the relapsed anal carcinoma cohort in patients treated with pelareorep and atezolizumab. Presentation Type: Poster Session Title: Poster Session C: Cancers of the Colon, Rectum, and Anus Session Date and Time: January 25, 2025, 7:00 - 7:55 a.m. PT The fourth cohort of the GOBLET study is evaluating pelareorep combined with the checkpoint inhibitor atezolizumab in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The treatment combination met the pre-defined efficacy success criteria for Stage 1 of its Simon two-stage design, and Stage 2 enrollment of 18 additional evaluable patients has begun. Updated results from this cohort show that four of twelve evaluable patients achieved a partial response for an objective response rate of 33%. This includes one patient with a prolonged complete response that persisted for over 15 months. This is notable because historical response rates to checkpoint inhibitor monotherapy are low, generally 10-24%1-3. There continue to be no safety concerns with the treatment regimen. At treatment cycle four, tumor-infiltrating lymphocyte (TIL) clonal expansion has been observed in the three responding patients for which data is available. It is anticipated that the additional data from Stage 2 of this cohort will provide a sufficiently strong efficacy signal to move this treatment regimen into a registration-enabling study. Abstract Number: 730 Title: GOBLET study: Results of the safety run-in for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients treated with pelareorep + modified FOLFIRINOX +/- atezolizumab. Presentation Type: Poster Session Title: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract Session Date and Time: January 24, 2025, 11:30 a.m. – 1:00 p.m. PT A promising efficacy signal in metastatic pancreatic ductal adenocarcinoma (PDAC) was previously observed for the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab. To expand the potential of pelareorep to benefit PDAC patients, and after discussion with key opinion leaders, a cohort was added to the GOBLET study to evaluate pelareorep combined with modified FOLFIRINOX (mFOLFIRINOX) both with and without atezolizumab. This cohort is being funded by a US$5 million grant from the Pancreatic Cancer Action Network (PanCAN). The three-patient safety run-in for each treatment arm has completed enrollment, and patients have completed the necessary evaluation period. The safety data have been reviewed by the Data Safety Monitoring Board (DSMB) and Paul Ehrlich Institute (PEI), Germany's medical regulatory body, and they have recommended patient enrollment continue without modification. Abstracts from the ASCO Gastrointestinal Cancers Symposium are currently available on the event website, which can be accessed by clicking here. References Rao S, et al. Phase II study of retifanlimab in patients (pts) with squamous carcinoma of the anal canal (SCAC) who progressed following platinum-based chemotherapy. Annals of Oncology. 2020 September. doi: . Marabelle A, et al. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study. Lancet Gastroenterol Hepatol. 2022 May;7(5):446-454. doi: 10.1016/S2468-1253(21)00382-4. Lonardi S, et al. Randomized phase II trial of avelumab alone or in combination with cetuximab for patients with previously treated, locally advanced, or metastatic squamous cell anal carcinoma: the CARACAS study. J Immunother Cancer. 2021 November;9(11):e002996. doi: 10.1136/jitc-2021-002996. PMID: 34815354; PMCID: PMC8611452. 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 co-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 mFOLFIRINOX 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 plans to provide updates on the safety and efficacy of pelareorep-based combinations therapy; our expectation that additional data from the fourth cohort of our Stage 2 GOBLET study will provide a sufficiently strong efficacy signal to move the treatment regimen into a registration-enabling study; our plans to advance pelareorep to registration-enabling studies for the treatment of breast and pancreatic cancers; 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 Timothy McCarthy LifeSci Advisors +1-917-679-9282 [email protected] Media Contact for Oncolytics Michael Rubenstein LifeSci Communications [email protected] Logo - SOURCE Oncolytics Biotech® Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyASCOPhase 2Fast Track

21 Jan 2025

·www.businesswire.com

Natera to Present New Data at the 2025 ASCO GI Symposium

AUSTIN, Texas--( BUSINESS WIRE )-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that the first set of abstracts have been released from several studies that will be shared at the American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI) taking place Jan. 23 – 25, 2025 in San Francisco, CA. BESPOKE CRC Study New data will be presented in an oral presentation on Jan. 25 from BESPOKE CRC, a multicenter, prospective, observational study in colorectal cancer (CRC). The study underscores Signatera’s capability as a prognostic and a predictive biomarker in a cohort of over 1,000 patients wherein post-surgical Signatera-positivity was predictive of inferior outcomes in stage II patients [disease-free survival (DFS) (HR=10.4; p<0.0001), and stage III patients (HR=10.1; p<0.0001)]. 24-month DFS estimates for stages II-III combined were 91.7% for Signatera-negative and 41.4% for Signatera-positive. Signatera-positive patients benefitted from adjuvant treatment while Signatera-negative patients did not, and clearance of ctDNA during and after treatment led to superior DFS outcomes. Additional data from the study will be shared during the symposium illustrating the impact of MRD detection on clinical decision-making. The data show that even in the early days of MRD commercialization, a significant number of oncologists escalated or de-escalated post-surgical chemotherapy plans based on Signatera results, and the vast majority of oncologists found that Signatera results strengthened the treatment plan under consideration. In addition, surveillance with Signatera enabled a high rate of curative-intent surgery among recurrent patients. Readouts in Tissue-Free MRD and Early Cancer Detection Initial results from a clinical performance study on Natera’s novel tissue-free MRD detection test will be presented, where high sensitivity and specificity were observed in patients evaluable for clinical outcomes. The study demonstrated that the tissue-free MRD assay was prognostic, with MRD-positive patients showing inferior recurrence-free survival. The data also showed that the test was predictive, as MRD-positive patients benefited from adjuvant therapy whereas MRD-negative patients did not. In addition, the data showed strong concordance between the tissue-free MRD test and the gold standard Signatera test, with a positive percent agreement of 86% (95% CI:77-93%) and a negative percent agreement of 98% (95% CI: 95-100%). Natera will also present case-control data in early cancer detection, including data from screen-detected colorectal cancer cases from the CIRCULATE study and controls from the PROCEED-CRC study, respectively. The data reports an overall sensitivity of 95% (95% CI: 92-99%) and a specificity of 91% (95% CI: 88-94%). Among patients with stage I disease, sensitivity was 92% overall. Stage-adjusted sensitivity was 91% in screen-detected individuals. “ This data at ASCO GI demonstrates the ongoing strength of Signatera complemented by our exciting innovation pipeline,” said Adham Jurdi, MD, senior medical director in oncology at Natera. “ The results from BESPOKE CRC highlight the potential value of Signatera-based MRD detection for treatment-decision making, with strong findings in clinical utility. Our readouts in early cancer detection and tissue-free MRD offer great promise for expanding Natera’s portfolio to help millions of additional patients with cancer.” Full list of Signatera presentations and activities during ASCO GI Oral Presentations Jan. 25, 1:00 PM PT | Abstract # 15 | Stage II-III Colorectal Cancer (Oral Presentation) Presenter: Purvi K. Shah, MD, MBBS, Virginia Cancer Institute Circulating Tumor DNA for Detection of Molecular Residual Disease (MRD) in Patients (pts) with Stage II/III Colorectal Cancer (CRC): Final Analysis of the BESPOKE CRC sub cohort Jan. 25, 1:00 PM PT | Abstract # LBA14 | Colon Cancer (Oral Presentation) Presenter: Jonathan A. Nowak, MD, PhD, Brigham and Women's Hospital Prognostic and predictive role of circulating tumor DNA (ctDNA) in stage III colon cancer treated with celecoxib: Findings from CALGB (Alliance)/SWOG 80702 P osters Jan. 23, 11:30 AM PT | Abstract # TPS512 | Gastroesophageal adenocarcinoma (Poster) Presenter: Elizabeth Catherine Smyth, MD, Oxford University Hospitals NHS Foundation Trust A single arm phase II trial of trastuzumab deruxtecan in patients with gastroesophageal adenocarcinoma cancer who are ctDNA and HER2 posiative: DECIPHER Jan. 23, 11:30 AM PT | Abstract # 836 | Gastrointestinal cancers (Poster) Presenter: Sakti Chakrabarti, MD, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Short interval circulating tumor DNA (ctDNA) kinetics as a predictor of tumor response in patients with gastrointestinal (GI) cancer receiving immune checkpoint inhibitor (ICI)-based treatment Jan. 25, 7:00 AM PT | Abstract # 266 | Tissue-free MRD testing (Poster) Presenter: John Paul Y.C. Shen, MD, University of Texas MD Anderson Cancer Center Development of a methylation-based, tissue-agnostic test for the detection of molecular residual disease by circulating tumor DNA Jan. 25, 7:00 AM PT | Abstract # 232 | Early cancer detection: colorectal cancer (Poster) Presenter: Yoshiaki Nakamura, MD, PhD, Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East Performance of a blood-based screening test for the early detection of colorectal cancer Jan. 25, 7:00 AM PT | Abstract # TPS306 | Early cancer detection: Trial in Progress (Poster) Presenter: Sarah Sawyer, PhD, Clinical Trial Operations, Natera, Inc. Austin, TX, USA Trial in progress for a colorectal cancer detection blood test Jan. 25, 7:00 AM PT | Abstract # LBA 22 | Colorectal cancer (Poster) Presenter: Hideaki Bando, MD, National Cancer Center Hospital Japan A Randomized, Double-Blind, Phase III Study Comparing Trifluridine/Tipiracil (FTD/TPI) Versus Placebo in Patients with Molecular Residual Disease Following Curative Resection of Colorectal Cancer (CRC): The ALTAIR Study Jan. 25, 7:00 AM PT | Abstract # 220 | Metastatic colorectal cancer (Poster) Presenter: D.E. van Steijn, MSc, Netherlands Cancer Institute Longitudinal ctDNA measurements for treatment response monitoring in patients with metastatic colorectal cancer undergoing systemic therapy: The ORCA trial Jan. 25, 7:00 AM PT | Abstract # 284 | Locally advanced rectal cancer (Poster) Presenter: Jun Watanabe, MD, PhD, Department of Colorectal Surgery, Kansai Medical University Circulating tumor DNA for predicting complete response to total neoadjuvant therapy in locally advanced rectal cancer: ENSEMBLE-2 Jan 25, 7:00 AM PT | Abstract # 263 | Rectal adenocarcinoma (Poster) Presenter: Seth Felder, MD, H. Lee Moffitt Cancer Center Correlation of mid-chemoradiation ctDNA results and clinical complete response to total neoadjuvant therapy (TNT) for locally advanced rectal adenocarcinoma Jan 25, 7:00 AM PT | Abstract # 48 | Colorectal cancer (Poster) Presenter: Elisabeth Arrondo, BSc, Translational Research Support Office, National Cancer Center Hospital East Molecular characteristics and prognostic impact of GNAS mutation in colorectal cancer: An international collaborative study between United States and Japan About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov .

Clinical ResultASCOPhase 2ImmunotherapyPhase 3

15 Jan 2025

·www.prnewswire.com

Regulatory Approval Clears Path for Oncolytics Biotech® to Advance Promising Pancreatic Cancer Treatment, Following a Review of Safety Data

New pancreatic cancer cohort moves forward with full enrollment of 30 patients in Stage 1 SAN DIEGO and CALGARY, AB, Jan. 15, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients. Following a positive safety review by the independent Data Safety Monitoring Board (DSMB), which recommended continuation, the PEI's approval allows Cohort 5 to progress to full enrollment. Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year. "Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep's promise in this disease. GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy. Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed." About GOBLET Cohort 5 The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations. 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 co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate 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 PDAC 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 or later advanced and unresectable anal cancer patients; and Pelareorep in combination with mFOLFIRINOX 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; continued enrollment in the GOBLET study and the expansion thereof to additional participants; our belief that pelareorep is poised to advance to registration-enabling studies for the treatment of breast and pancreatic cancers; 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 Timothy McCarthy LifeSci Advisors +1-917-679-9282 [email protected] Logo - SOURCE Oncolytics Biotech® Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyASCOFast TrackPhase 2

100 Deals associated with Tipiracil Hydrochloride/Trifluridine

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KEGG	Wiki	ATC	Drug Bank
-	Tipiracil Hydrochloride/Trifluridine	L01BC	DB08937

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2-positive gastric cancer	KR	Jeil Pharmaceutical Co., Ltd.	17 Oct 2019
Metastatic Gastric Carcinoma	AU	SERVIER LABORATORIES (AUST.) PTY. LTD.	23 May 2017
Metastatic Gastroesophageal Junction Adenocarcinoma	AU	SERVIER LABORATORIES (AUST.) PTY. LTD.	23 May 2017
Gastroesophageal junction adenocarcinoma	EU	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	IS	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	LI	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	NO	Les Laboratoires Servier SAS	25 Apr 2016
Metastatic Colorectal Carcinoma	US	Taiho Oncology, Inc.	22 Sep 2015
Colorectal Cancer	JP	Taiho Pharmaceutical Co., Ltd.	24 Mar 2014
Stomach Cancer	JP	Taiho Pharmaceutical Co., Ltd.	24 Mar 2014

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	US	Adir SRL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	JP	Adir SRL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	BE	Adir SRL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	DK	Adir SRL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	FI	Adir SRL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	HU	Adir SRL	21 Apr 2022
Solid tumor	Phase 3	FR	Servier Group	30 Jan 2022
Adenocarcinoma of large intestine	Phase 2	FR	Les Laboratoires Servier SAS	31 Jan 2025
Dihydropyrimidine Dehydrogenase Deficiency	Phase 2	FR	Les Laboratoires Servier SAS	31 Jan 2025
Gastrooesophageal junction cancer	Phase 2	FR	Les Laboratoires Servier SAS	31 Jan 2025

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2300078241 (ASCO_GI2025)	Phase 2	Metastatic Colorectal Carcinoma Third line RAS mutations	26	Fruquintinib	iptgwfeewr(nizrzzwfat) = nrudthvnqz stjmfvxtes (lgjulkhuxn ) View more	Positive	23 Jan 2025
				TAS-102	iptgwfeewr(nizrzzwfat) = gbhwhfxrvw stjmfvxtes (lgjulkhuxn ) View more
SUNLIGHT (ASCO_GI2025)	Not Applicable	Metastatic Colorectal Carcinoma	-	FTD-TPI	crhdmfzsnl(gexoueopgt) = mqrccjfuip gxpyqkknby (nsminwruey, 6.1 - 6.6) View more	Positive	23 Jan 2025
				FTD-TPI+bev	crhdmfzsnl(gexoueopgt) = shqdmdiaij gxpyqkknby (nsminwruey, 8.0 - 10.1) View more
ASCO_GI2025	Not Applicable	Colorectal Cancer Third line	75	TAS-102	dqfwfkidci(wfnonpktoy) = fjbsrtczrc kuoruywehn (twdxbtaqxl )	Negative	23 Jan 2025
				Chemotherapy rechallenge	dqfwfkidci(wfnonpktoy) = gfudkafgaz kuoruywehn (twdxbtaqxl )
NCT02848079 (ASCO_GI2025)	Phase 1/2	Colorectal Cancer RAS mutated	54	TAS102 with oxaliplatin (TASOX)	ajwvpcvnhc(tlqfthulig) = btowlyhzos foleemgzba (kxehvgkbag ) View more	Positive	23 Jan 2025
NCT06202001 (ASCO_GI2025)	Phase 2	Metastatic Colorectal Carcinoma Second line	60	Trifluridine/tipiracil (TAS-102) + Irinotecan + Bevacizumab	yholgyykec(sihbxoaeul) = ahdicbqaav fmfccqhpfk (mfxhsipbvy ) View more	Positive	23 Jan 2025
BeTAS trial (ASCO_GI2025)	Not Applicable	Metastatic Colorectal Carcinoma Third line RAS mutations	208	Trifluridine/tipiracil and bevacizumab (FTD/TPI+BEV)	ryeycdxzuo(yasdeobylq) = uoyswhpalr nzgzevnpsb (rviweodxrd ) View more	Positive	23 Jan 2025
SUNLIGHT (ASCO_GI2025)	Phase 3	Metastatic Colorectal Carcinoma	639	FTD-TPI	nvedemxapy(mzcwcdakmt) = itllovdgsb oiwicpsqev (ywyfjdiebb ) View more	Positive	23 Jan 2025
				FTD-TPI+bev	nvedemxapy(mzcwcdakmt) = ubwblkxxne oiwicpsqev (ywyfjdiebb ) View more
ASCO_GI2025	Not Applicable	MSI-high \| deficient MMR	18	trifluridine/tipiracil (FTD/TPI + BEV)	kktnmscafs(roltvsccdm) = jufqsuemvx pezcjdeuzh (utrfihbyqw, 3.6 - 41.4) View more	Positive	23 Jan 2025
				trifluridine/tipiracil (FTD/TPI)	vywqauejsi(ysumfsvddq) = ooquqhhrvr etobboyyfn (qslulqavqi )
HGCSG2302 (ASCO_GI2025)	Not Applicable	Advanced gastric carcinoma	164	FTD/TPI plus Ramucirumab	whbofxzhci(ambddiswxc) = 48.6% vs 52.4% (p=0.707) uelpspimwg (duhxtbbfid ) View more	Positive	23 Jan 2025
				FTD/TPI
NCT05201352 (Pubmed) Manual	Phase 1	Metastatic Colorectal Carcinoma	17	XB2001 + FTD/TPI + bevacizumab	vxfsekkggk(gdriyqtlxm) = None dqjyusvmnd (fmlcmhfplu ) View more	Positive	17 Jan 2025

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