Trifluridine

AMGEN PRESENTS NEW LUMAKRAS® (SOTORASIB) PLUS VECTIBIX® (PANITUMUMAB) DATA IN PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER

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Sunday, October 22, 2023

THOUSAND OAKS, Calif., Oct. 22, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced data from the global Phase 3 CodeBreaK 300 trial evaluating two doses of LUMAKRAS® (sotorasib) (960 mg or 240 mg) in combination with Vectibix® (panitumumab). Both doses demonstrated a statistically significant superiority in progression-free survival (PFS) over the investigator's choice of therapy in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). The results are being presented today at the Presidential Symposium 2 session as a late-breaking oral presentation (LBA10) during the European Society for Medical Oncology (ESMO) 2023 Congress in Madrid, Spain, with simultaneous publication in the New England Journal of Medicine.

Key Points: 
  • Both doses demonstrated a statistically significant superiority in progression-free survival (PFS) over the investigator's choice of therapy in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC).
  • Among secondary endpoints, higher objective response rate (ORR) and disease control rate (DCR) were observed in patients treated with LUMAKRAS plus Vectibix at both doses versus investigator's choice of care.
  • Patients at both dose regimens of LUMAKRAS plus Vectibix experienced a longer duration of treatment than those treated with investigator's choice therapy.
  • Based on the CodeBreaK 300 primary analysis results, Amgen is planning to submit these data to regulatory authorities.

Bold Therapeutics Selected as 2023 'Company to Watch' by Life Sciences British Columbia

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Thursday, September 14, 2023

VANCOUVER, BC, Sept. 14, 2023 /PRNewswire/ -- Bold Therapeutics, a clinical-stage biopharmaceutical company developing novel metallotherapeutics, is announcing its selection by Life Sciences British Columbia (LSBC) for the 2023 'Company to Watch' Honour Roll.

Key Points: 
  • VANCOUVER, BC, Sept. 14, 2023 /PRNewswire/ -- Bold Therapeutics, a clinical-stage biopharmaceutical company developing novel metallotherapeutics, is announcing its selection by Life Sciences British Columbia (LSBC) for the 2023 'Company to Watch' Honour Roll.
  • This year marks the 25th Annual Life Sciences BC Awards that brings together industry leaders, researchers, investors, and stakeholders to celebrate their remarkable achievements.
  • The ceremony will provide an opportunity to showcase the cutting-edge research, technological advancements, and collaborations that drive innovation in British Columbia's thriving life sciences community and takes place on September 14, 2023 at the Vancouver Convention Centre.
  • Bold Therapeutics' BOLD-100 is a first-in-class metallotherapeutic with a unique multimodal mechanism-of-action.

Merck and Eisai Provide Update on Phase 3 Trials of KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) In Certain Patients With Advanced Melanoma (LEAP-003) and Metastatic Colorectal Cancer (LEAP-017)

Retrieved on: 
Friday, April 7, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230405005809/en/
    LEAP-003: Merck and Eisai are discontinuing the Phase 3 LEAP-003 trial evaluating KEYTRUDA plus LENVIMA for the first-line treatment of adults with unresectable or metastatic melanoma.
  • Merck and Eisai are informing study investigators of the decision and advising them to reach out to patients in the study regarding treatment.
  • In both the LEAP-003 and LEAP-017 trials, the safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination.
  • Results from the LEAP-003 and LEAP-017 trials do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination.

Drug Combination Meets Survival Endpoint in Phase III Pivotal Trial Involving Participants With Refractory Metastatic Colorectal Cancer

Retrieved on: 
Monday, September 12, 2022

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).

Bold Therapeutics' BOLD-100 Early mCRC Data to be Showcased at 2022 Metals in Medicine Gordon Research Conference

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Friday, June 24, 2022

VANCOUVER, BC, June 24, 2022 /PRNewswire/ --Bold Therapeutics, a clinical-stage biopharmaceutical company, announced that they will be attending the Metals in Medicine Gordon Research Conference focusing on Advancing the Use of Metal-Based Compounds and Nanotheranostics for Personalized Medicine.

Key Points: 
  • VANCOUVER, BC, June 24, 2022 /PRNewswire/ --Bold Therapeutics, a clinical-stage biopharmaceutical company, announced that they will be attending the Metals in Medicine Gordon Research Conference focusing on Advancing the Use of Metal-Based Compounds and Nanotheranostics for Personalized Medicine.
  • Adam Carie, Director of CMC & Nonclinical Development, will be presenting on behalf of Bold Therapeutics in the "Clinical Advances for Metals in Medicine" session.
  • "Bold Therapeutics is excited to present these remarkable results at the Gordon Research Metals in Medicine Conference showcasing the cutting-edge, multi-disciplinary work being performed at Vancouver-based Bold Therapeutics" noted Dr. Carie.
  • For more information about Bold Therapeutics, please visit: https://www.bold-therapeutics.com/
    For more information about the Gordon Research Conference, please visit:

City of Hope Researchers Help Find Improved Treatment Options for Patients With Advanced Colorectal Cancer

Retrieved on: 
Tuesday, December 14, 2021

City of Hope, a world-renowned cancer research and treatment organization, today announced study results of a Phase 2 clinical trial showing monotherapy with sotorasib resulted in anti-tumor activity and a favorable benefit-risk profile among heavily pretreated patients with advanced colorectal cancer.

Key Points: 
  • City of Hope, a world-renowned cancer research and treatment organization, today announced study results of a Phase 2 clinical trial showing monotherapy with sotorasib resulted in anti-tumor activity and a favorable benefit-risk profile among heavily pretreated patients with advanced colorectal cancer.
  • Colorectal cancer is the third most common cancer diagnosed in the United States and the second leading cause of cancer death, according to the Centers for Disease Control and Prevention.
  • Currently, overall response rate for patients with recurrent metastatic colorectal cancer who take approved options, such as trifluridine and regorafenib, ranges from 1-4%, Fakih said.
  • A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nations Best Hospitals in cancer by U.S. News & World Report.

Servier announces outcome from the primary analysis of the Phase III SOLSTICE trial assessing LONSURF® (trifluridine/tipiracil) + bevacizumab in a 1st line setting for patients with unresectable mCRC non-eligible for intensive therapy

Retrieved on: 
Friday, October 22, 2021

SOLSTICE was designed to evaluate the superiority of LONSURF (trifluridine/tipiracil) + bevacizumab over capecitabine + bevacizumab in 1st line unresectable metastatic colorectal cancer (mCRC) in patients non-eligible for intensive therapy.

Key Points: 
  • SOLSTICE was designed to evaluate the superiority of LONSURF (trifluridine/tipiracil) + bevacizumab over capecitabine + bevacizumab in 1st line unresectable metastatic colorectal cancer (mCRC) in patients non-eligible for intensive therapy.
  • D., Head of Late Stage and Life Cycle Management, and Deputy Head Oncology and Immuno-Oncology Therapeutic Area, Servier.
  • The clinical value of LONSURF in its current indications remains unchanged, and the ongoing Phase III SUNLIGHT trial (LONSURF + bevacizumab versus LONSURF in 3rd line mCRC) is proceeding as planned.
  • SOLSTICE is an open-label, randomized, multicentre Phase III trial in 856 unresectable metastatic colorectal cancer patients who are not candidates for, or do not require, intensive therapy.