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Clinical Trial News

FDA Clears Epitomee Capsule for Weight Management

  • The FDA has cleared the Epitomee capsule as an adjunct to lifestyle modification for weight management in adults with a BMI of 25 to 40 kg/m2.
  • The Epitomee capsule expands in the stomach to create a feeling of fullness, later disintegrating in the intestines for natural elimination.
  • Clinical trial data demonstrated significantly greater weight reduction with Epitomee compared to placebo (P < .0001) over 24 weeks.
  • A significant 55.5% of patients taking Epitomee achieved at least 5% body weight loss, demonstrating its effectiveness in weight management.

The Effect of Extended Use of the EPITOMEE CAPSULE (ELECT)

NCT04994769CompletedNot Applicable
Epitomee medical
Posted 8/31/2021

The Effect of Epitomee Capsule on Body Weight in Patients With Overweight and Obesity

NCT04222322CompletedNot Applicable
Epitomee medical
Posted 9/15/2020

GENFIT Reports Positive Financial Results in H1 2024 Driven by Iqirvo's U.S. Launch

  • GENFIT reported €61.6 million in cash and equivalents as of June 30, 2024, excluding a €48.7 million milestone from Ipsen for Iqirvo's U.S. launch.
  • The company's revenues reached €59.0 million, boosted by the €48.7 million milestone payment invoiced in June 2024.
  • A positive opinion from the EMA for Iqirvo anticipates a final decision in H2 2024, potentially triggering a €26.5 million milestone upon pricing approval.
  • Phase 2 trial for VS-01 in Acute on-Chronic Liver Failure (ACLF) is progressing with protocol modifications to address recruitment challenges.

ESMO 2024: Key Breast Cancer Advances Highlighted

  • Final KEYNOTE-522 data confirmed pembrolizumab's benefit in neoadjuvant chemotherapy for early-stage triple-negative breast cancer, improving 5-year overall survival.
  • NATALEE trial's 4-year update showed ribociclib plus aromatase inhibition significantly improved invasive disease-free survival in high-risk, hormone receptor-positive early breast cancer.
  • DESTINY-Breast12 trial demonstrated trastuzumab deruxtecan's significant intracranial activity in HER2-positive metastatic breast cancer patients with brain metastases.
  • ICARUS-BREAST01 trial revealed promising objective response rates and progression-free survival with patritumab deruxtecan in HER3-positive, hormone receptor-positive, HER2-negative metastatic breast cancer.

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

NCT03701334Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 12/7/2018

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

NCT04472429Active, Not RecruitingPhase 3
Incyte Corporation
Posted 1/12/2021

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

Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44)

NCT02676349Active, Not RecruitingPhase 2
Institut de Cancérologie de Lorraine
Posted 10/13/2016

Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO

NCT03815890RecruitingPhase 2
The Netherlands Cancer Institute
Posted 10/4/2019

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

NCT03036488Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 3/7/2017

A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma

NCT03116412RecruitingNot Applicable
Uppsala University
Posted 6/8/2017

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

NCT03522246Active, Not RecruitingPhase 3
pharmaand GmbH
Posted 5/14/2018

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

NCT04246177Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/22/2020

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

NCT04221945Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/12/2020

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

NCT03997123Active, Not RecruitingPhase 3
AstraZeneca
Posted 6/25/2019

Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer

NCT04965766Active, Not RecruitingPhase 2
Gustave Roussy, Cancer Campus, Grand Paris
Posted 5/11/2021

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

NCT04634877Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 1/10/2021

Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)

NCT02362594Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 7/16/2015

Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery

NCT03493425RecruitingPhase 2
ECOG-ACRIN Cancer Research Group
Posted 3/12/2019

Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence

NCT03127995Active, Not RecruitingNot Applicable
UNICANCER
Posted 9/1/2016

A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors

NCT04503278RecruitingPhase 1
BioNTech Cell & Gene Therapies GmbH
Posted 9/16/2020

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

NCT03732677Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/16/2018

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

Phase III Radium 223 mCRPC-PEACE III

NCT02194842Active, Not RecruitingPhase 3
European Organisation for Research and Treatment of Cancer - EORTC
Posted 10/1/2015

Pembrolizumab Approved for Mesothelioma; Patritumab Deruxtecan Shows Promise in NSCLC

  • FDA has expanded the approval of pembrolizumab (Keytruda) in combination with pemetrexed and cisplatin for previously untreated advanced/metastatic malignant pleural mesothelioma.
  • Patritumab deruxtecan demonstrated a statistically significant improvement in progression-free survival versus doublet chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
  • A novel three-drug regimen yielded an 80% response rate in a small study of patients with advanced chronic myelogenous leukemia or high-risk acute myeloid leukemia.

Regulatory Roundup: Key Approvals and Submissions in Late September 2024

  • Apellis received regulatory approval for its geographic atrophy treatment, offering a new option for patients facing this vision-threatening condition.
  • Glycomine secured orphan drug designation for its therapeutic aimed at addressing a rare metabolic disorder, potentially expediting its development.
  • Regulatory submissions and approvals spanned multiple companies, including Merck, Novartis, and Sanofi, highlighting continued pharmaceutical innovation.

Rezolute's Ersodetug Advances in Phase 3 for Hyperinsulinism; RZ402 Shows Promise in DME

  • Rezolute's ersodetug receives FDA clearance to proceed with Phase 3 sunRIZE study in the U.S. for congenital hyperinsulinism (HI) treatment.
  • A Phase 3 study for ersodetug in tumor HI is slated to commence in the first half of 2025, expanding its clinical application.
  • RZ402 demonstrates positive Phase 2 results in diabetic macular edema (DME) patients, showing significant reduction in central subfield thickness.
  • Rezolute's financial position remains stable with $127.1 million in cash, despite an increased net loss due to higher R&D expenses.

Rogaratinib Plus Atezolizumab Shows Promise in Cisplatin-Ineligible Urothelial Cancer

  • A phase 1b trial evaluated rogaratinib combined with atezolizumab in cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma (UC) overexpressing FGFR mRNA.
  • The recommended dose of rogaratinib 600 mg plus atezolizumab 1200 mg demonstrated a manageable safety profile and a high objective response rate of 53.8%.
  • Efficacy was observed in tumors with low PD-L1 expression and was not dependent on FGFR3 gene alterations, suggesting broad potential benefit.
  • The combination therapy provides a potential treatment option for patients with locally advanced/metastatic UC who are not eligible for cisplatin-based chemotherapy.

Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma

NCT03473756CompletedPhase 1
Bayer
Posted 5/15/2018

EMA Backs Wegovy for Obesity-Related Heart Failure, Expanding Therapeutic Uses

  • The European Medicines Agency (EMA) has endorsed Novo Nordisk's Wegovy for treating heart failure in obese patients, marking its second supported use beyond weight loss.
  • Clinical trials demonstrated that Wegovy reduces heart failure-related symptoms and improves physical limitations and exercise function in patients with obesity-related HFpEF.
  • The EMA's decision reinforces Novo Nordisk's position on Wegovy's versatile health benefits, with a label update expected shortly to reflect these expanded uses.
  • Novo Nordisk plans to resubmit data to the FDA in 2025 regarding Wegovy's effectiveness in treating heart failure associated with obesity.

FDA Approves 420-mg Dosage of Trastuzumab-strf Biosimilar for HER2-Overexpressing Cancers

  • The FDA has approved the 420-mg strength of trastuzumab-strf (Hercessi), a biosimilar to trastuzumab (Herceptin), for HER2-overexpressing cancers.
  • This approval expands the availability of trastuzumab-strf, which was initially approved in a 150-mg dose in April 2024.
  • Trastuzumab-strf is now approved for metastatic breast and gastric/gastroesophageal junction cancers that overexpress HER2.
  • The approval is based on data from pharmacokinetic similarity trials and a phase 3 trial demonstrating comparable safety and efficacy to the reference product.

Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer

NCT03084237CompletedPhase 3
Shanghai Henlius Biotech
Posted 11/1/2016

Elanco's Zenrelia (Ilunocitinib) Receives FDA Approval for Canine Dermatitis

  • Elanco's Zenrelia (ilunocitinib) has gained FDA approval as a once-daily oral treatment for pruritus associated with allergic dermatitis and atopic dermatitis in dogs.
  • A randomized, double-blind study demonstrated Zenrelia's noninferiority to a market-leading JAK inhibitor in relieving itch and skin lesions in dogs with atopic dermatitis.
  • Zenrelia is priced competitively, offering a potentially more affordable option for pet owners, with a consistent once-daily dosing regimen.
  • The drug's label includes a boxed warning regarding vaccine administration, advising discontinuation before and after vaccination due to potential risks.

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