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Clinical Trial News

Sanbexin Sublingual Tablets Granted FDA Breakthrough Therapy Designation for Ischemic Stroke

  • Simcere Pharmaceuticals' Sanbexin sublingual tablets receive Breakthrough Therapy designation from the FDA for ischemic stroke treatment.
  • The designation aims to expedite the development and regulatory review of Sanbexin, addressing a critical unmet need in stroke therapy.
  • Phase III clinical trial data demonstrated significant improvements in neurological recovery and autonomy for ischemic stroke patients compared to placebo.
  • Sanbexin's unique sublingual formulation allows for rapid absorption, potentially enhancing treatment flexibility and improving patient outcomes.

FDA Approves Roche's Ocrevus ZUNOVO for Relapsing and Progressive Multiple Sclerosis

  • The FDA has approved Ocrevus ZUNOVO (ocrelizumab & hyaluronidase-ocsq) for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
  • Ocrevus ZUNOVO is administered via a roughly 10-minute subcutaneous injection twice a year by a healthcare professional.
  • The approval is based on the Phase III OCARINA II trial, demonstrating similar efficacy and safety to the IV formulation of Ocrevus.
  • Ocrevus and Ocrevus ZUNOVO remain the only therapies approved for both RMS and PPMS, offering increased flexibility for patients and providers.

Rinatabart Sesutecan Shows Promise in Heavily Pretreated Ovarian and Endometrial Cancers

  • Rinatabart sesutecan (Rina-S) demonstrated a 50% confirmed objective response rate (ORR) in ovarian cancer patients at 120 mg/m2 Q3W, regardless of FRα expression levels.
  • The Phase 1/2 study results support Rina-S potential in advanced ovarian and endometrial cancers, especially in platinum-resistant cases, warranting further Phase 3 evaluation.
  • Common treatment-emergent adverse events included anemia, neutropenia, and nausea, with infrequent dose reductions and no observed ocular toxicities or interstitial lung disease.

Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

NCT05579366RecruitingPhase 1
ProfoundBio US Co.
Posted 12/7/2022

FDA's Biosimilar Landscape: Growing Market Share and Policy Changes Shape Future Access

  • The U.S. biosimilars market is experiencing rapid growth, with 56 FDA-approved products and projected sales reaching up to $129 billion over the next 5 years, demonstrating increasing adoption in healthcare systems.
  • Recent policy changes include CMS implementing temporary payment increases for biosimilars under Medicare Part B, offering ASP plus 8% reimbursement to encourage market competition and improve accessibility.
  • Healthcare systems implementing strategic biosimilar programs have achieved significant cost savings, with Providence St. Joseph Health system reporting $26.9 million in savings and 62% biosimilar adoption over 22 months.

Pembrolizumab Demonstrates Sustained Survival Benefits in Advanced Melanoma After 10-Year Follow-Up

  • The KEYNOTE-006 study shows pembrolizumab provides a significant overall survival (OS) benefit compared to ipilimumab in advanced melanoma patients over 10 years.
  • After 10 years, the OS rate in the pembrolizumab arm was 34.0% compared to 23.6% in the ipilimumab arm (HR, 0.71; 95% CI, 0.60-0.85).
  • Patients who completed at least 94 weeks of pembrolizumab treatment had impressive 6- and 8-year OS rates from week 94 of 91.8% and 80.8%, respectively.
  • A second course of pembrolizumab showed promising activity, with 5 patients achieving complete response and a median modified PFS of 51.8 months.

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

NCT03486873RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 8/21/2018

Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006)

NCT01866319CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 8/28/2013

Bicycle Therapeutics Presents Promising Oncology Pipeline Updates at ESMO 2024

• Zelenectide pevedotin shows a 45% ORR in metastatic urothelial cancer (mUC) with an 11.1-month median duration of response and a favorable safety profile. • BT5528 demonstrates a 45% ORR in mUC patients at 6.5 mg/m2 every two weeks, with a differentiated safety profile and emerging antitumor activity. • BT7480 exhibits a favorable safety profile and preliminary antitumor activity in advanced Nectin-4-associated solid tumors, supporting further dose exploration. • Bicycle Toxin Conjugates show relatively low rates of treatment-related peripheral neuropathy, suggesting improved tolerability compared to other drug conjugates.

JSKN003 Demonstrates Promising Efficacy in HER2-Positive Cancers and Platinum-Resistant Ovarian Cancer

• JSKN003, an anti-HER2 bispecific antibody-drug conjugate, shows a 56.8% objective response rate in heavily pretreated platinum-resistant ovarian cancer patients. • In HER2-positive solid tumors, JSKN003 achieves a 75% objective response rate and an 89.3% disease control rate, indicating strong antitumor activity. • The bispecific ADC exhibits a favorable safety profile with manageable adverse events, supporting further clinical evaluation in various cancer types. • These findings, presented at ESMO Congress 2024, highlight JSKN003's potential as a novel treatment option for advanced, heavily pretreated cancers.

First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors

NCT05494918CompletedPhase 1
Alphamab (Australia) Co Pty Ltd.
Posted 9/2/2022

Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors

NCT05744427RecruitingPhase 1
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Posted 3/15/2023

FDA Approves Ocrevus Zunovo as First Subcutaneous Option for Multiple Sclerosis

  • The FDA has approved Ocrevus Zunovo, a subcutaneous formulation of ocrelizumab, for relapsing and primary progressive multiple sclerosis.
  • Ocrevus Zunovo offers a twice-yearly, 10-minute injection, providing an alternative to intravenous infusions.
  • The approval is supported by Phase III OCARINA II trial data, demonstrating comparable efficacy and safety to intravenous Ocrevus.
  • This new formulation aims to improve treatment access and flexibility for patients and healthcare providers.

A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

NCT05232825CompletedPhase 3
Hoffmann-La Roche
Posted 5/3/2022

RYBREVANT® Plus Chemotherapy Shows Positive Overall Survival Trend in EGFR-Mutated Lung Cancer

  • Updated results from the Phase 3 MARIPOSA-2 study reveal that RYBREVANT® (amivantamab) combined with chemotherapy demonstrates consistent benefits in post-progression outcomes for patients with EGFR-mutated NSCLC.
  • The combination therapy shows a favorable trend toward improved overall survival compared to chemotherapy alone, suggesting a potential shift in the treatment landscape for this patient population.
  • Amivantamab plus chemotherapy significantly improves treatment discontinuation rates, with nearly five times as many patients remaining on therapy at 18 months compared to chemotherapy alone.
  • Patients treated with the amivantamab combination experienced a 27 percent reduction in the risk of symptomatic progression, highlighting the potential for more durable treatment options.

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT04988295Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/17/2021

Luvelta Plus Bevacizumab Shows Promise in Late-Stage Ovarian Cancer

  • Sutro Biopharma's luvelta, combined with bevacizumab, achieved a 56% objective response rate at the recommended phase 2 dose (4.3 mg/kg) in late-stage ovarian cancer patients.
  • The combination therapy demonstrated a 35% overall response rate, irrespective of Folate Receptor-α (FRα) expression, offering a potential non-biomarker-driven treatment approach.
  • An expansion phase with an additional 23 patients is ongoing, with initial data expected in the first half of 2025, to further evaluate the efficacy and safety of the combination.
  • No new safety signals were observed, reinforcing the tolerability of luvelta in combination with bevacizumab, with neutropenia being the most common adverse event.

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