
A prostate cancer patient has said that he would likely survive the disease had a screening programme been available when he was younger.
Grant…
A prostate cancer patient has said that he would likely survive the disease had a screening programme been available when he was younger.
Grant…
Originally published in Synapse on October 12, 2000.
Three winners of the Nobel Prize in medicine were announced in Stockholm, Sweden on Oct. 9. Prize winners Arvid Carlsson, Paul Greengard, and Eric Kandel were honored for their research and…
They have sold out venues on both sides of the Atlantic. Their first-ever gig was opening for a former member of Arcade Fire. Their 2024 album has been acclaimed as sounding like a lost classic of 1970s rock. Their two top tracks, Bright and…
A train of solar storms is barreling toward Earth, with four coronal mass ejections (CMEs) expected to hit over the next few days. Any potential impact could trigger impressive auroras in northern skies and possibly even at…
Scientists have finally uncovered the exact DNA sequence where human chromosomes fuse to form Robertsonian chromosomes, a mystery that has puzzled researchers for over a century.
Using advanced genome sequencing at the Stowers…
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The addition of tucatinib (Tukysa) to maintenance therapy with trastuzumab (Herceptin) and pertuzumab (Perjeta) displayed a statistically significant improvement in progression-free survival (PFS) vs placebo as a first-line treatment for patients with HER2-positive metastatic breast cancer, according to a news release from the drug’s developer, Pfizer Inc.1
The investigational agent was assessed in combination with trastuzumab and pertuzumab across the aforementioned patient population in the
“[HER2-positive] breast cancer is a particularly challenging subtype, with many patients experiencing disease progression despite effective treatments in the first-line setting,” Erika Hamilton, MD, principal investigator of HER2CLIMB-05 and director of Breast Cancer Research at the Sarah Cannon Research Institute (SCRI), stated in the news release on the study findings.1 “The [phase 3] HER2CLIMB-05 results demonstrate that the addition of [tucatinib] to first-line maintenance therapy may further lower the risk of disease progression or death, with a treatment that has a well-established safety profile.”
The double-blind phase 3 trial enrolled patients with HER2-positive metastatic breast cancer following taxane-based induction therapy. Those who completed induction therapy with trastuzumab, pertuzumab, and a taxane with no evidence of disease progression were randomly assigned 1:1 to receive tucatinib (n = 326) or placebo (n = 328) plus trastuzumab and pertuzumab as maintenance.
Patients in both arms received trastuzumab at 6 mg/kg intravenously or 600 mg subcutaneously plus pertuzumab at 420 mg intravenously every 21 days as maintenance therapy.2 Those in the investigational arm received tucatinib at 300 mg orally twice daily every 21 days, with those in the control arm receiving matching placebo.
The primary end point of the trial was investigator-assessed PFS. Secondary end points included overall survival, PFS per blinded independent central review, central nervous system PFS, health-related quality of life, and adverse effects (AEs).2
Warnings and precautions of treatment with tucatinib include severe diarrhea, dehydration, hypotension, acute kidney injury, and death. Additionally, patients may be at risk of hepatotoxicity, including alanine aminotransferase increases, aspartate aminotransferase increases, and bilirubin increases. Furthermore, tucatinib may cause embryo-fetal toxicities among patients who are pregnant or of reproductive potential.
In the phase 3 HER2CLIMB trial (NCT02614794), serious AEs were reported in 26% of the tucatinib arm, the most common of which included diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). The most common fatal AEs included sudden death, sepsis, dehydration, and cardiogenic shock.
Dose reductions related to AEs occurred in 21% of patients, the most common of which were hepatotoxicity (8%) and diarrhea (6%).
Currently, tucatinib is approved for the treatment of patients with HER2-positive metastatic breast cancer in the third-line setting in the US as well as more than 50 countries. Additionally, it is approved by the FDA when used in combination with trastuzumab and capecitabine in adult patients with advanced unresectable or metastatic HER2-positive disease who received at least 1 prior HER2-based treatment in the metastatic setting in April 2020.3
“The positive results from HER2CLIMB-05, combined with [tucatinib’s] known safety profile in later-line settings, underscore its potential to play a meaningful role in front-line maintenance, where it may benefit a broader population of patients with [HER2-positive] disease,” Johanna Bendell, MD, chief development officer of Oncology at Pfizer, expressed in the news release.1 “We are grateful to the patients and investigators who contributed to this important research.”
London: Cleveland Clinic brought together global leaders in biotechnology, healthcare, academia, government and industry at today’s Life Science Summit to explore the transformative forces shaping the future of therapeutics.
During the international event – held at the Lanesborough Hotel near Cleveland Clinic London – Cleveland Clinic leaders also announced several new or expanded collaborations and shared details about Cleveland Clinic London’s new cancer centre.
The summit highlighted advancements in areas such as AI-driven drug discovery, personalized medicine and cancer treatments, offering attendees unique insights into the science, strategy and societal impact of modern medicine. With a dynamic mix of keynote addresses, scientific presentations and panel discussions, the event was designed to foster collaboration and highlight opportunities to fast-track the translation of research into transformative therapies.
“The Life Science Summit reflects our commitment to advancing medicine across the globe through innovation and collaboration,” said Tom Mihaljevic, M.D., CEO and President of Cleveland Clinic and holder of the Morton L. Mandel CEO Chair. “By bringing together international leaders from across disciplines, we aim to foster meaningful dialogue and accelerate progress in developing treatments that improve the lives of patients around the world.”
Panel discussions focused on topics such as AI, precision medicine, and next-generation therapies, as well as trends in life sciences investment. Highlighted sessions included:
The summit also featured a Cleveland Clinic Portfolio Showcase, highlighting cutting-edge therapies and technologies being developed through Cleveland Clinic Innovations.
Other new partnerships and updates were shared during the event and highlighted Cleveland Clinic’s steadfast progress in expanding state-of-the-art clinical care and robust life sciences research in the UK. These included:
As part of a global research enterprise, Cleveland Clinic London has made clinical research an integral component of daily operations, achieving several firsts in the UK private healthcare sector. Currently, 46 investigator-sponsored and commercial studies are open across all major specialties, with over 1,000 patients recruited to clinical trials by the end of 2024, including NHS portfolio multicentre studies. Additionally, Cleveland Clinic London caregivers authored more than 1,100 peer-reviewed papers in 2024.
Building on Cleveland Clinic’s partnership with IBM and the Science and Technology Facilities Council, Cleveland Clinic London is advancing AI-driven research to improve patient outcomes. In a pilot study, a research team is examining how common hospital procedures impact overall health and quality of life. Researchers are using clinical and advanced imaging data provided by Cleveland Clinic London BioResource, a repository which provides patients with the opportunity to consent to enhanced longitudinal data collection and analysis. Researchers aim to develop sophisticated AI models for multi-disease analysis, ultimately enhancing understanding and care for patients.
The Life Science Summit was supported by sponsorships from AstraZeneca, Bank of America, and Flagship Pioneering, as well as Jones Day and LifeArc.