Associated tags: Health, Urology, Allergy, Taiho Pharmaceutical, Medication, Patient, Oncology, Progression-free survival, Pharmaceutical industry, OS, Trifluridine/tipiracil, Bevacizumab, MD, Medical imaging, Safety, Research, PFS
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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.
ZUG, Switzerland, July 4, 2023 /PRNewswire/ -- Taiho Oncology Europe GmbH and Taiho Pharmaceutical Co., Ltd., announced today that the European Commission has granted conditional marketing authorization for LYTGOBI® (futibatinib) monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Key Points:
- "LYTGOBI is an oral molecularly targeted medication that may provide clinically meaningful outcomes for patients undergoing treatment for CCA."
- In this trial, patients received LYTGOBI orally once daily at a dose of 20mg until disease progression or unacceptable toxicity.
- Under the specific obligation to complete post-authorization measures for the conditional marketing authorization, Taiho has until October 2027 to provide additional clinical data on LYTGOBI.
- LYTGOBI should not be used during pregnancy unless the clinical condition of the women requires treatment with LYTGOBI.
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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:
Thursday, November 12, 2020
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Taiho Pharmaceutical Co., Ltd. Taiho Pharmaceutical Co., Ltd, (Taiho) and Lung Therapeutics, Inc. (Lung Tx) announced today an exclusive license agreement of LTI-01 , a recombinant human single-chain urokinase plasminogen activator, currently under development by Lung Tx for loculated pleural effusions , for the territory of Japan.
Key Points:
- Taiho Pharmaceutical Co., Ltd, (Taiho) and Lung Therapeutics, Inc. (Lung Tx) announced today an exclusive license agreement of LTI-01 , a recombinant human single-chain urokinase plasminogen activator, currently under development by Lung Tx for loculated pleural effusions , for the territory of Japan.
- View the full release here: https://www.businesswire.com/news/home/20201112005439/en/
Under the terms of the agreement, Taiho will obtain the rights for the development and commercialization of LTI-01 in Japan.
- LTI-01 is anticipated to promote drainage in LPE patients by lysis of fibrinous scar tissue in the pleural cavity.
- LTI-01 has the potential to be the first and only approved therapeutic for loculated pleural effusion patients, stated Brian Windsor, CEO of Lung Tx .
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Oncology PRINCETON, N.J., June 14, 2018 /PRNewswire/ --Taiho Oncology, Inc. and Servier today announced that clinical data for LONSURF (trifluridine and tipiracil, TAS-102) are being presented at the ESMO 20th World Congress on Gastrointestinal Cancer 2018 (ESMO-GI) in Barcelona, Spain, June 20 to 23.
Key Points:
- PRINCETON, N.J., June 14, 2018 /PRNewswire/ --Taiho Oncology, Inc. and Servier today announced that clinical data for LONSURF (trifluridine and tipiracil, TAS-102) are being presented at the ESMO 20th World Congress on Gastrointestinal Cancer 2018 (ESMO-GI) in Barcelona, Spain, June 20 to 23.
- In addition, Taiho announced that data for TAS-120, the Company's investigational compound being studied for the potential treatment of patients with cholangiocarcinoma, will be presented.
- The trial enrolled 507 subjects and was conducted in Japan, North America, Europe, Russia and Turkey, among other locations.
- In June 2015, Taiho Pharmaceutical Co., Ltd. entered into an exclusive license agreement with Servier for the co-development and commercialization of LONSURF.
TAS-114, combined with S-1, demonstrated a manageable safety profile and preliminary efficacy in heavily pretreated patients with advanced solid tumors.
Key Points:
- TAS-114, combined with S-1, demonstrated a manageable safety profile and preliminary efficacy in heavily pretreated patients with advanced solid tumors.
- In June 2015, Taiho Pharmaceutical Co., Ltd. entered into an exclusive license agreement with Servier for the co-development and commercialization of LONSURF.
- Obtain complete blood counts prior to and on day 15 of each cycle of LONSURF and more frequently as clinically indicated.
- Entirely independent, the Group reinvests 25 percent of its turnover (excluding generic drugs) in research and development and uses all its profits for development.
