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Cabozantinib/Nivolumab Shows Consistent Benefits in RCC, Except for Favorable-Risk Group

  • CheckMate 9ER trial data confirms that cabozantinib plus nivolumab significantly improves progression-free survival (PFS) and overall survival (OS) in metastatic clear cell RCC patients.
  • Favorable-risk RCC patients do not experience the same OS benefit from cabozantinib/nivolumab compared to intermediate- and poor-risk groups, mirroring findings from other TKI/IO combinations.
  • Cabozantinib/nivolumab demonstrates manageable toxicity and allows patients to stay on therapy longer, with potential post-discontinuation benefits attributed to immunotherapy's long half-life.
  • The combination of nivolumab and ipilimumab has shown long-term benefits, including treatment-free survival, in intermediate- and poor-risk RCC, according to extended follow-up data from CheckMate 214.

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

NCT03141177Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 7/23/2017

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

NCT02811861Active, Not RecruitingPhase 3
Eisai Inc.
Posted 10/13/2016

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

NCT02231749CompletedPhase 3
Bristol-Myers Squibb
Posted 10/16/2014

Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)

NCT02853331Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 9/16/2016

Patritumab Deruxtecan Shows Promise in HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitor Resistance

  • Patritumab deruxtecan (HER3-DXd) demonstrates a 53.5% response rate in heavily pre-treated HR+/HER2- metastatic breast cancer patients resistant to CDK4/6 inhibitors.
  • The ICARUS-BREAST01 phase II trial reports a median progression-free survival of 9.4 months with patritumab deruxtecan, suggesting improved outcomes compared to conventional third-line chemotherapies.
  • Researchers identified potential factors influencing treatment response, including the distribution of HER3-positive cells within the tumor and drug-induced immune response.
  • Patritumab deruxtecan may represent a new therapeutic option for advanced hormone-dependent breast cancer, warranting further investigation in larger studies.

Tivozanib Monotherapy Shows Superiority Over Tivozanib Plus Nivolumab in Metastatic RCC After ICI Progression

  • The phase 3 TiNivo-2 trial revealed that tivozanib monotherapy demonstrated superior progression-free survival (PFS) compared to the combination of tivozanib and nivolumab in metastatic renal cell carcinoma (RCC).
  • Median PFS was 7.4 months with tivozanib alone versus 5.7 months with the combination, indicating that immune checkpoint inhibitor (ICI) rechallenge may not be beneficial in this setting.
  • The study suggests that tivozanib monotherapy at 1.34 mg can be considered a second-line treatment option for patients with RCC who have progressed after prior ICI therapy.
  • The reduced dose of tivozanib in the combination arm (0.89 mg) may have impacted the efficacy, highlighting the importance of optimal dosing in VEGFR TKI therapy.

Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC

NCT03136627CompletedPhase 1
AVEO Pharmaceuticals, Inc.
Posted 3/22/2017

A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment

NCT04338269CompletedPhase 3
Hoffmann-La Roche
Posted 7/28/2020

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

FDA Approves Subcutaneous Ocrelizumab (Ocrevus Zunovo) for Multiple Sclerosis

  • The FDA has approved subcutaneous ocrelizumab (Ocrevus Zunovo) for relapsing and primary progressive multiple sclerosis (MS).
  • Ocrevus Zunovo offers a new twice-yearly, 10-minute injection option, providing greater flexibility for patients and healthcare providers.
  • The approval was based on the OCARINA II trial, demonstrating comparable efficacy and safety to intravenous ocrelizumab.
  • Injection site reactions were the most common adverse events, but were generally mild to moderate and did not lead to treatment discontinuation.

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

NCT05232825Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 5/3/2022

Cidara Therapeutics Cuts Workforce to Prioritize CD388 Influenza Prevention Program

  • Cidara Therapeutics is reducing its workforce by 30%, impacting 20 positions, to focus on the clinical development of CD388, an influenza prevention therapy.
  • The company plans to initiate a Phase IIb trial of CD388 for influenza A and B prevention in the Northern Hemisphere's upcoming flu season.
  • Cidara reacquired rights to CD388 from Johnson & Johnson for $85 million and is now responsible for its development and marketing, with potential milestone payments to J&J.
  • Despite promising Phase IIa data showing a numerical decrease in influenza virus replication, the reduction was not statistically significant.

The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults

NCT05523089CompletedPhase 2
Cidara Therapeutics Inc.
Posted 9/9/2022

Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects

NCT05619536CompletedPhase 1
Cidara Therapeutics Inc.
Posted 10/18/2022

Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

NCT05285137CompletedPhase 1
Cidara Therapeutics Inc.
Posted 3/14/2022

Moberg Pharma's MOB-015 Phase 3 Trial Shows Lower Than Expected Clinical Cure Rate

  • Moberg Pharma reports that a subset of patients in their North American Phase 3 study of MOB-015 achieved clinical cure for nail fungus at a rate lower than anticipated.
  • Cipher Pharmaceuticals, which holds Canadian marketing rights to MOB-015, acknowledges the update from Moberg Pharma regarding the clinical trial results.
  • Cipher Pharmaceuticals emphasizes that the outcome of the MOB-015 trial does not currently impact the company's sales and earnings profile.
  • Cipher Pharmaceuticals remains focused on the integration of the Natroba™ business and other potential growth opportunities.

AZD8205 Shows Promise in Heavily Pretreated Solid Tumors: ESMO 2024

  • AZD8205, a novel antibody-drug conjugate, demonstrates a manageable safety profile in heavily pretreated patients with advanced or metastatic solid tumors.
  • The Phase I/II trial of AZD8205 showed promising clinical activity, particularly in gynecologic tumors and breast cancer, with partial responses observed.
  • Common grade 3 or higher adverse effects included neutropenia, anemia, and decreased white blood cell count, manageable with dose adjustments.
  • Phase II expansion cohorts are underway to further evaluate AZD8205 in ovarian, breast, endometrial, and biliary tract cancers.

A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies

NCT05123482RecruitingPhase 1
AstraZeneca
Posted 10/18/2021

Inflammatix Secures $57 Million to Advance TriVerity Sepsis Test

  • Inflammatix has raised $57 million to support regulatory filing and commercialization of its TriVerity rapid blood test for acute infection and sepsis.
  • The TriVerity system measures gene expression levels in blood related to immune response, providing results in about 30 minutes using machine learning.
  • The FDA granted breakthrough device designation to TriVerity, intended to expedite clearance and Medicare coverage; regulatory submission is already underway.
  • Inflammatix plans to expand its commercial team and conduct clinical studies while awaiting FDA clearance for the TriVerity test in the coming months.

FDA Approves Dupixent as First Biologic for Adolescents with Chronic Rhinosinusitis with Nasal Polyps

  • The FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
  • This approval marks the first time a biologic is specifically indicated for adolescent CRSwNP, offering an alternative to standard treatments like steroids and surgery.
  • The decision was supported by data from the SINUS-24 and SINUS-52 trials, which demonstrated significant improvements in nasal congestion, polyp size, and sense of smell.
  • Dupixent, a fully human monoclonal antibody, inhibits the IL-4 and IL-13 pathways, addressing type 2 inflammation, a key driver in CRSwNP, and is not an immunosuppressant.

Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

NCT02898454CompletedPhase 3
Sanofi
Posted 11/28/2016

A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps

NCT02912468CompletedPhase 3
Sanofi
Posted 12/5/2016

Engineered Toxoplasma Gondii Delivers Therapeutic Proteins to Mouse Brain

  • Researchers engineered Toxoplasma gondii to deliver large proteins across the blood-brain barrier in mice, overcoming a major obstacle in brain-targeted drug delivery.
  • The engineered parasite efficiently delivered various therapeutic proteins to neurons and could simultaneously deliver multiple proteins, demonstrating versatility.
  • Delivery of MeCP2, a target in Rett syndrome, to brain organoids showed the protein bound to methylated DNA and altered gene expression, indicating functionality.
  • In mice, the engineered T. gondii distributed MeCP2 throughout the brain, with highest levels in the cortex, suggesting a potential therapeutic approach.

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