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Clinical Trial News

Semaglutide Outperforms Liraglutide for Weight Loss in Real-World Study

• Semaglutide (Ozempic, Wegovy) leads to ≥10% weight loss in 61% of obesity patients and 23% of diabetes patients, significantly higher than liraglutide (Saxenda). • Liraglutide achieved similar weight loss in only 29% of obesity patients and 12% of type 2 diabetes patients over one year. • The study highlights that higher doses of semaglutide and adherence to the drug schedule are associated with greater weight loss. • Findings emphasize the importance of medication persistence and patient-specific factors in achieving clinically significant weight reduction with GLP-1 receptor agonists.

AstraZeneca's Truqap (capivasertib) Launched in Korea as First AKT Inhibitor for Breast Cancer

  • AstraZeneca Korea has launched Truqap (capivasertib), the first AKT inhibitor approved in Korea, for HR-positive/HER2-negative breast cancer patients with specific mutations.
  • The approval was based on the CAPItello-291 trial, which showed a significant improvement in median progression-free survival when combined with fulvestrant.
  • Truqap targets PIK3CA, AKT1, or PTEN mutations, present in approximately 50% of HR-positive/HER2-negative breast cancer patients, addressing a critical need for effective second-line therapies.
  • Concerns remain regarding the financial burden on patients due to the high cost of next-generation sequencing (NGS) required to identify eligible patients.

Inhaled Colistimethate Shows Promise for Bronchiectasis, Despite COVID-19 Impact

  • In the PROMIS-I trial, inhaled colistimethate sodium significantly reduced the mean annual exacerbation rate in bronchiectasis patients with Pseudomonas aeruginosa infections.
  • The PROMIS-II trial, impacted by the COVID-19 pandemic, did not show a significant reduction in exacerbation rates with the same treatment.
  • A meta-analysis of PROMIS-I, pre-pandemic PROMIS-II data, and an earlier phase II study supported the efficacy of colistimethate sodium in reducing exacerbation rates.
  • Inhaled colistimethate sodium demonstrated a safety profile similar to placebo, with low rates of bronchospasm and manageable adverse events.

Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I)

NCT03093974CompletedPhase 3
Zambon SpA
Posted 6/6/2017

Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.

NCT03460704TerminatedPhase 3
Zambon SpA
Posted 1/29/2018

Endo's Collagenase Clostridium Histolyticum Shows Promise in Phase 2 Plantar Fibromatosis Study

  • Endo presented Phase 2 clinical trial data of collagenase clostridium histolyticum (CCH) for plantar fibromatosis at the AOFAS annual meeting.
  • The study demonstrated a trend toward pain reduction with CCH treatment compared to placebo, as measured by the Foot Function Index.
  • CCH showed nominally significant improvements in investigator assessments of the condition, nodule hardness, and nodule consistency.
  • The safety profile of CCH in the study was consistent with previous findings, with mostly mild to moderate local adverse events reported.

Librexia Program Aims for Inclusive Cardiovascular Clinical Trials

  • The Librexia program is a Phase 3 clinical trial focusing on novel treatments for blood clotting diseases, including acute coronary syndrome and atrial fibrillation.
  • The trial actively recruits women and people of color to ensure inclusive and equitable results relevant to all patient populations.
  • Cardiovascular diseases and stroke remain leading causes of death, with disparities in care partly due to underrepresentation in clinical trials.
  • Diverse representation in clinical trials is crucial for understanding medication benefits across all population segments, according to Dr. Roxana Mehran.

Moderna Adjusts Financial Outlook and Product Timelines, Shares Decline

  • Moderna has revised its financial projections, pushing back its break-even target to 2028 due to adjustments in its product development timeline and commercial challenges.
  • The company forecasts 2025 sales between $2.5 billion and $3.5 billion, falling short of analysts' expectations and its own 2024 projections, impacting investor confidence.
  • Moderna is pacing its new product launches, including flu and cancer vaccines, with regulatory processes taking longer than initially anticipated.
  • Despite the financial adjustments, Moderna plans to submit an FDA application to expand the approval of its mRESVIA shot for RSV to high-risk adults under 60.

Trastuzumab Deruxtecan Shows Promise in HER2+ Breast Cancer with Brain Metastases

  • Trastuzumab deruxtecan (T-DXd) demonstrates substantial and durable clinical activity in HER2-positive advanced breast cancer patients, including those with brain metastases.
  • The DESTINY-Breast12 trial showed a 12-month progression-free survival rate of 61.6% in patients with baseline brain metastases treated with T-DXd.
  • Central nervous system overall response rate was 71.7% in patients with measurable CNS disease, indicating significant intracranial activity of T-DXd.
  • Safety profile of T-DXd was consistent with previous reports, though interstitial lung disease remains an important risk, especially with concomitant steroid use.

Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

NCT04987203Active, Not RecruitingPhase 3
AVEO Pharmaceuticals, Inc.
Posted 9/9/2021

Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

NCT00542451CompletedPhase 2
Dana-Farber Cancer Institute
Posted 10/1/2007

Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study

NCT03820063Active, Not RecruitingPhase 2
Borstkanker Onderzoek Groep
Posted 2/27/2019

A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC

NCT05246514Active, Not RecruitingPhase 2
AstraZeneca
Posted 7/13/2022

Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

NCT04685135Active, Not RecruitingPhase 3
Mirati Therapeutics Inc.
Posted 2/23/2021

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

NCT02564900CompletedPhase 1
Daiichi Sankyo Co., Ltd.
Posted 9/1/2015

Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

NCT04784715Active, Not RecruitingPhase 3
AstraZeneca
Posted 4/26/2021

NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial

NCT05569811Active, Not RecruitingPhase 2
SOLTI Breast Cancer Research Group
Posted 11/25/2022

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

NCT03529110Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 8/9/2018

Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

NCT04644237CompletedPhase 2
Daiichi Sankyo
Posted 3/19/2021

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

NCT04739761Active, Not RecruitingPhase 3
AstraZeneca
Posted 6/22/2021

T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)

NCT01853748Active, Not RecruitingPhase 2
Dana-Farber Cancer Institute
Posted 5/1/2013

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]

NCT03329690CompletedPhase 2
Daiichi Sankyo Co., Ltd.
Posted 11/2/2017

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

NCT03734029Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/27/2018

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

NCT03523585Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 8/1/2018

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT03735121CompletedPhase 3
Hoffmann-La Roche
Posted 12/14/2018

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

NCT02614794CompletedPhase 2
Seagen Inc.
Posted 1/28/2016

Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases

NCT04752059CompletedPhase 2
Medical University of Vienna
Posted 7/28/2020

DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)

NCT04014075CompletedPhase 2
Daiichi Sankyo
Posted 11/26/2019

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

NCT04494425Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/24/2020

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

NCT03505710TerminatedPhase 2
Daiichi Sankyo
Posted 5/21/2018

Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer

NCT04744831CompletedPhase 2
Daiichi Sankyo
Posted 3/5/2021

DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease

NCT04420598CompletedPhase 2
MedSIR
Posted 5/25/2020

Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens

NCT04989816CompletedPhase 2
AstraZeneca
Posted 8/20/2021

Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2

NCT01996267Active, Not RecruitingPhase 3
The Netherlands Cancer Institute
Posted 12/1/2013

A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression

NCT04610528Active, Not RecruitingEarly Phase 1
SOLTI Breast Cancer Research Group
Posted 12/22/2020

A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

NCT04482309RecruitingPhase 2
AstraZeneca
Posted 8/18/2020

Enhertu Demonstrates Significant Activity in HER2-Positive Metastatic Breast Cancer with Brain Metastases

• Enhertu showed substantial clinical activity in HER2-positive metastatic breast cancer patients, including those with active brain metastases, based on a post-hoc analysis. • In patients with active brain metastases who had not received prior local CNS therapy, Enhertu achieved a CNS Objective Response Rate (ORR) of 82.6%. • For patients with brain metastases who had progressed following prior local CNS therapy, Enhertu demonstrated a CNS ORR of 50.0%. • The safety profile of Enhertu was consistent with previous trials, with interstitial lung disease (ILD) or pneumonitis observed in both cohorts with and without brain metastases.

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]

NCT03329690CompletedPhase 2
Daiichi Sankyo Co., Ltd.
Posted 11/2/2017

Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer

NCT04744831CompletedPhase 2
Daiichi Sankyo
Posted 3/5/2021

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

NCT03505710TerminatedPhase 2
Daiichi Sankyo
Posted 5/21/2018

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

NCT03529110Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 8/9/2018

A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC

NCT05246514Active, Not RecruitingPhase 2
AstraZeneca
Posted 7/13/2022

Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

NCT04644237CompletedPhase 2
Daiichi Sankyo
Posted 3/19/2021

Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens

NCT04989816CompletedPhase 2
AstraZeneca
Posted 8/20/2021

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

NCT03734029Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/27/2018

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

NCT04739761Active, Not RecruitingPhase 3
AstraZeneca
Posted 6/22/2021

A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

NCT04482309RecruitingPhase 2
AstraZeneca
Posted 8/18/2020

DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)

NCT04014075CompletedPhase 2
Daiichi Sankyo
Posted 11/26/2019

Oshkosh Defense Submits Proposal for Robotic Combat Vehicle (RCV) Phase II

  • Oshkosh Defense has submitted its proposal for the U.S. Army's Robotic Combat Vehicle (RCV) Phase II program, aiming to provide innovative technologies for enhanced soldier performance.
  • The Oshkosh RCV is designed to be modular and payload agnostic, allowing for rapid integration of future technologies and adaptability in multi-domain operations.
  • Oshkosh delivered two RCV Platform Prototypes in August 2024 as part of Phase I, supporting mobility testing and soldier feedback for Phase II selection.
  • Phase II, valued at $118.9 million, requires contractors to deliver nine RCV Production Representative Prototypes by early 2026.

FDA Approves Hearing Aid Software for AirPods, Tremfya for Ulcerative Colitis, and Grants Breakthrough Therapy Designation to Plozasiran

  • The FDA has approved over-the-counter hearing aid software for certain Apple AirPods Pro models, demonstrated to provide comparable performance to professionally fitted hearing aids.
  • Guselkumab (Tremfya) has received FDA approval for treating moderate to severe active ulcerative colitis in adults, based on Phase 2b/3 QUASAR study results showing significant clinical remission.
  • Plozasiran, an investigational RNAi therapy, was granted Breakthrough Therapy designation by the FDA for reducing triglycerides in adults with familial chylomicronemia syndrome (FCS).

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