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Clinical Trial News

GSK Seeks FDA Approval for Blenrep Combination Therapy in Multiple Myeloma

  • GSK's Blenrep, previously withdrawn, seeks FDA approval in combination with Velcade and dexamethasone for multiple myeloma patients after one prior therapy.
  • The application is based on DREAMM-7 and DREAMM-8 Phase III trials, demonstrating statistically significant improvements in progression-free survival.
  • Blenrep's combination offers a potential advantage over CAR-T therapy due to its off-the-shelf nature and simpler administration.
  • GlobalData forecasts Blenrep to generate $1.4 billion in 2030, offering new competition in the BCMA-targeted therapy landscape.

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT04246047Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 5/7/2020

Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

NCT04484623Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 10/1/2020

China Approves MSD's Welireg (belzutifan) for VHL-Associated Tumors

  • China's NMPA has approved MSD's Welireg (belzutifan) for treating specific von Hippel-Lindau (VHL) disease-associated tumors in adults, offering a non-surgical option.
  • The approval is based on Phase II LITESPARK-004 trial results, demonstrating significant objective response rates in renal cell carcinoma, CNS hemangioblastomas, and pNET.
  • Welireg, a hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, marks the 17th global approval for this indication, providing a systemic therapy option for Chinese patients.
  • MSD is continuing to investigate Welireg in advanced renal cell carcinoma and other tumor types through a comprehensive clinical development program.

Clearside Biomedical Highlights Suprachoroidal Delivery Technology at Global Medical Meetings

  • Clearside Biomedical presented its suprachoroidal delivery technology and pipeline program data at medical meetings across Asia, Europe, and the United States.
  • ODYSSEY trial topline results for CLS-AX in wet AMD were presented at the Ophthalmology Innovation Summit and the Asia-Pacific Vitreo-Retina Society (APVRS) Congress.
  • Clearside hosted suprachoroidal injection procedure demonstrations at APVRS, showcasing the SCS Microinjector® technology and novel delivery approach.
  • Arctic Vision is advancing XIPERE towards potential approval in China, Australia, and Singapore, increasing interest in Clearside's delivery approach.

FDA Clears Philips' ROCC for Remote Radiology Operations

  • Philips secures FDA 510(k) clearance for its Radiology Operations Command Center (ROCC), enhancing remote scanning and protocol management capabilities.
  • The ROCC system, compatible with various MR and CT systems, connects imaging experts with technologists across different locations.
  • A pilot study showed a 9% increase in scanning throughput with no exam recalls, demonstrating the system's efficiency.
  • The remote capabilities empower clinicians to deliver timely diagnoses and improve patient care by addressing the shortage of skilled technologists.

Merck's Winrevair Shows Promise in Phase 3 PAH Trial, Prompting Early Stop

  • Merck's Winrevair (sotatercept-csrk) significantly reduced morbidity or mortality risk in PAH patients in the Phase 3 ZENITH trial compared to placebo.
  • The independent data monitoring committee recommended an early halt to the ZENITH trial due to the positive results, allowing all participants access to Winrevair.
  • Winrevair, already approved in the U.S. and other countries, modulates vascular proliferation and has shown promise in improving hemodynamics in PAH.
  • The five-year mortality rate for PAH patients is approximately 43%, highlighting the critical need for effective treatments like Winrevair.

Merck's Winrevair Shows Significant Morbidity and Mortality Reduction in PAH Patients

  • Merck's Winrevair (sotatercept-csrk) met the primary endpoint in the Phase 3 ZENITH trial, significantly reducing morbidity and mortality in PAH patients.
  • The trial was stopped early due to overwhelming efficacy, and participants will be offered Winrevair through an open-label extension study.
  • Winrevair is the first activin signaling inhibitor approved for PAH, improving the balance between pro- and anti-proliferative signaling.
  • The drug is already approved in the U.S. and other countries, with recent submission for approval in Japan based on positive trial results.

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

NCT04896008CompletedPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 12/1/2021

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

NCT04796337Active, Not RecruitingPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 5/12/2021

Merck's Winrevair Shows Overwhelming Efficacy in Phase 3 ZENITH Trial for Advanced PAH

  • Merck's WINREVAIR™ (sotatercept-csrk) demonstrated overwhelming efficacy in the Phase 3 ZENITH trial for treating advanced pulmonary arterial hypertension (PAH).
  • The ZENITH trial was halted early due to WINREVAIR's significant impact on reducing the risk of death, lung transplantation, or PAH-related hospitalizations.
  • All participants in the ZENITH study will be offered the opportunity to receive WINREVAIR, highlighting its potential to change PAH management practices.
  • WINREVAIR is already approved in the U.S. and other countries based on the STELLAR trial, with recent submission for approval in Japan.

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

NCT04896008CompletedPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 12/1/2021

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

NCT04796337Active, Not RecruitingPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 5/12/2021

Advantage Therapeutics Launches Klothea Bio to Develop Klotho-Based Anti-Aging Therapies

  • Advantage Therapeutics has spun off a new subsidiary, Klothea Bio, focused exclusively on developing mRNA therapies that boost Klotho protein production to combat age-related diseases.
  • The newly formed Klothea Bio has secured seed funding led by Longevitytech.fund, a venture capital firm specializing in longevity biotechnology, with initial research targeting metabolic syndrome.
  • Klotho protein, which naturally decreases with age, offers multiple anti-aging properties including neuroprotection, antioxidative effects, and tumor suppression, with potential applications in Alzheimer's disease, cancer, and obesity.

Merck Halts Phase 3 HYPERION Trial of Winrevair Early After Positive ZENITH Results

  • Merck's Phase 3 HYPERION trial of Winrevair (sotatercept) for pulmonary arterial hypertension (PAH) is stopped early due to positive results from the ZENITH trial.
  • The decision, made with the FDA and a steering committee, allows all HYPERION participants access to Winrevair in the SOTERIA extension study.
  • Winrevair, already approved in the U.S. and 38 countries, showed significant efficacy in the STELLAR and ZENITH trials, leading to the HYPERION halt.
  • HYPERION findings will be available later this year, adding to the growing evidence supporting Winrevair's role in PAH treatment.

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)

NCT04576988CompletedPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 1/25/2021

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension

NCT03738150CompletedPhase 2
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 4/19/2019

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

NCT04796337Active, Not RecruitingPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 5/12/2021

Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

NCT04811092CompletedPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 3/18/2022

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)

NCT03496207CompletedPhase 2
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 6/13/2018

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

NCT04896008CompletedPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 12/1/2021

Eton Pharmaceuticals Acquires U.S. Rights to Amglidia for Neonatal Diabetes

• Eton Pharmaceuticals has acquired U.S. rights to Amglidia (glyburide oral suspension) from AMMTeK for treating neonatal diabetes mellitus. • Amglidia, already EMA-approved and available in Europe, addresses the unmet need for an FDA-approved oral treatment for this rare condition. • Eton plans to meet with the FDA in early 2025 and anticipates submitting an NDA for Amglidia in 2026, leveraging existing European safety and efficacy data. • The acquisition aligns with Eton's focus on pediatric endocrinology and expands its portfolio of treatments for rare diseases.

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