Associated tags: Bone marrow, Patient, Cancer, Caregiver, Pharmaceutical industry, Society, Health, Safety, Medical imaging
Locations: CANADA, ONTARIO, SWITZERLAND
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Sunday, December 10, 2023
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Hematology Data from the study were shared during an oral presentation ( Abstract #548 ) at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition.
Key Points:
- Data from the study were shared during an oral presentation ( Abstract #548 ) at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition.
- Based on these results and the potential for reduced treatment burden, oral decitabine and cedazuridine may be a viable alternative to intravenous or subcutaneous HMAs."
- In this study of 1,569 patients, 160 received oral DEC-C and 1,409 received intravenous/subcutaneous (IV/SC) HMAs.
- As a leader in the development of orally administered anti-cancer agents, Taiho Oncology is pleased to see how outcomes of this real-world study show some of the potential benefits of an oral therapy in myelodysplastic syndromes."
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MD PRINCETON, N.J. and CAMBRIDGE, Mass., Aug. 3, 2023 /PRNewswire/ -- Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc., announced today the launch of the REZILIENT3 trial (NCT05973773, Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors), a global Phase 3 clinical trial evaluating the combination of zipalertinib and chemotherapy as a potential first-line treatment for adult patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutation and who meet additional criteria.
Key Points:
- Phase 3 trial will assess progression-free survival of zipalertinib plus chemotherapy versus chemotherapy in adult patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR exon 20 insertion mutations
PRINCETON, N.J. and CAMBRIDGE, Mass., Aug. 3, 2023 /PRNewswire/ -- Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc., announced today the launch of the REZILIENT3 trial ( NCT05973773 , Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors), a global Phase 3 clinical trial evaluating the combination of zipalertinib and chemotherapy as a potential first-line treatment for adult patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutation and who meet additional criteria.
- NSCLC is a common form of lung cancer and up to 4% of all cases have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype.1 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations, with insertions at exon 20 accounting for up to 12% of these mutations.1
"Patients with NSCLC who have EGFR exon 20 insertion mutations are known to have poorer outcomes than those with more common EGFR mutations,1" said Volker Wacheck, MD, PhD, Senior Vice President, Clinical Development, Taiho Oncology, Inc. "Advancing care for this subset of patients with NSCLC is essential to advancing care in NSCLC overall."
- The launch of the REZILIENT3 trial follows a Phase 1 / 2a clinical trial ( NCT04036682 ) of zipalertinib in patients with NSCLC harboring EGFR exon 20 insertion mutations.
- Results demonstrated the therapeutic potential of zipalertinib in heavily pretreated patients and were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.2 Updated data from this trial were recently published in the Journal of Clinical Oncology.3
"The initiation of the Phase 3 trial for zipalertinib in the first-line setting is an important step forward for this clinical research program, as it represents an opportunity for zipalertinib to help more patients with EGFR exon 20 insertion mutation NSCLC," said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology, Inc. "We look forward to working with our partners at Taiho to rapidly assess zipalertinib in the front line, while in parallel continuing to advance our pivotal Phase 2b trial in patients who have received prior systemic treatment for locally advanced or metastatic disease."
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Wednesday, August 2, 2023
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Pharmaceutical industry PRINCETON, N.J., Aug. 2, 2023 /PRNewswire/ -- Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved LONSURF® (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
Key Points:
- PRINCETON, N.J., Aug. 2, 2023 /PRNewswire/ -- Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved LONSURF® (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
- "Notably, the use of LONSURF plus bevacizumab in these patients did not result in an increase in potentially intolerable side effects that might limit the utility of this combination."
- On July 31, 2023, Servier, which conducted the SUNLIGHT trial with Taiho Oncology, received approval from the European Commission for LONSURF in combination with bevacizumab for the treatment of adult patients with mCRC who have received two prior anti-cancer treatment regimens, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.
- The Marketing Authorization covers the 27 countries of the European Union as well as Iceland, Northern Ireland, Liechtenstein and Norway.
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Tuesday, January 17, 2023
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Pharmaceutical industry These data will be shared during an oral presentation (Abstract #392020) on January 21, 2023 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco.
Key Points:
- These data will be shared during an oral presentation (Abstract #392020) on January 21, 2023 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco.
- The SUNLIGHT trial investigated the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone in patients with refractory mCRC following disease progression or intolerance on two prior chemotherapy regimens.
- This improvement in OS represents a 39% reduction in the risk of death in patients with refractory mCRC.
- Findings from the SUNLIGHT trial represent an important development, which will be welcomed by the colorectal cancer community."
Retrieved on:
Tuesday, January 17, 2023
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Laboratoires Servier These data will be shared during an oral presentation (Abstract #392020) on January 21, 2023 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco.
Key Points:
- These data will be shared during an oral presentation (Abstract #392020) on January 21, 2023 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco.
- This improvement in OS represents a 39% reduction in the risk of death in patients with refractory mCRC.
- “Coupled with the fact that cases of colorectal cancer are increasing, there is an urgent need for new treatment options that can extend survival in patients with metastatic colorectal cancer in the later stages of disease.
- The percentage of patients who experienced severe adverse events (Grade ≥3) was similar in the trifluridine/tipiracil plus bevacizumab and trifluridine/tipiracil groups: 72.4% versus 69.5%, respectively.
Retrieved on:
Monday, December 12, 2022
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MD PRINCETON, N.J. and PLEASANTON, Calif., Dec. 12, 2022 /PRNewswire/ -- Taiho Oncology, Inc. and Astex Pharmaceuticals, Inc. today announced preliminary data from the Phase 3 ASCERTAIN trial assessing overall and leukemia-free survival in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML) harboring biallelic TP53 mutations following treatment with oral decitabine and cedazuridine (ASTX727). The data are being presented today as an oral presentation (Abstract #854) at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans.
Key Points:
- The data are being presented today as an oral presentation ( Abstract #854 ) at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans.
- In the study, the population of patients harboring a TP53 mutation (44 of 125 patients) was characterized by allelic status: 14 patients had biallelic mutations and 30 patients had monoallelic mutations without other chromosomal deletions.
- The primary endpoint of the study was total 5-day area-under-the-curve (AUC) equivalence of oral decitabine and cedazuridine and IV decitabine.
- Astex, the Astex logo, Taiho Oncology, the Taiho Oncology logo and INQOVI are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries.
Retrieved on:
Friday, September 30, 2022
LYTGOBI previously received breakthrough, orphan drug and priority review designations from the FDA.
Key Points:
- LYTGOBI previously received breakthrough, orphan drug and priority review designations from the FDA.
- Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- In this trial, patients received LYTGOBI orally once daily at a dose of 20mg until disease progression or unacceptable toxicity.
- LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
Retrieved on:
Friday, September 30, 2022
LYTGOBI previously received breakthrough, orphan drug and priority review designations from the FDA.
Key Points:
- LYTGOBI previously received breakthrough, orphan drug and priority review designations from the FDA.
- Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- In this trial, patients received LYTGOBI orally once daily at a dose of 20mg until disease progression or unacceptable toxicity.
- LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
Retrieved on:
Monday, September 12, 2022
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Cancer Combining trifluridine/tipiracil with bevacizumab demonstrated the potential to extend survival in these patients who have limited therapeutic options.
Key Points:
- Combining trifluridine/tipiracil with bevacizumab demonstrated the potential to extend survival in these patients who have limited therapeutic options.
- New treatment options are urgently needed as we seek to reduce the growing global burden of colorectal cancer.
- SUNLIGHT is a multinational, open-label, active-controlled, two-arm Phase III trial to investigate the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in patients with refractory mCRC following two chemotherapy regimens.
- The primary objective was to demonstrate the superiority of trifluridine/tipiracil plus bevacizumab over trifluridine/tipiracil alone, in terms of OS (primary endpoint).
Retrieved on:
Wednesday, March 30, 2022
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Taiho Futibatinib is an investigational, oral, potent, selective and irreversible small-molecule inhibitor of FGFR1, 2, 3 and 4.
Key Points:
- Futibatinib is an investigational, oral, potent, selective and irreversible small-molecule inhibitor of FGFR1, 2, 3 and 4.
- The FDA provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of September 30, 2022.
- It is this subset of patients with CCA that encompasses the NDA for futibatinib.
- "The Taiho group, working as one, will continue to do its utmost to deliver this agent to those in need."
