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Clinical Trial News

Zydus Healthcare to Conduct Phase III Trial for Glycopyrrolate/Indacaterol Inhaler

  • Zydus Healthcare will conduct a Phase III clinical trial for its fixed-dose combination of glycopyrrolate and indacaterol metered-dose inhalation, as recommended by the CDSCO panel.
  • The decision follows a review of Zydus Healthcare's bioequivalence study report and justification for a Phase III clinical trial waiver by the Subject Expert Committee (SEC).
  • The glycopyrrolate and indacaterol combination is intended for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
  • The Phase III clinical trial protocol must be submitted to CDSCO for further review by the committee before the trial can commence.

Combination Therapies Reshape Frontline HCC Treatment Landscape

  • Combination regimens, including STRIDE (single tremelimumab and regular-interval durvalumab), are transforming first-line HCC treatment, offering personalized options.
  • HIMALAYA trial's 5-year data showed STRIDE achieved a median OS of 16.43 months versus 13.77 months with sorafenib, marking the longest follow-up in unresectable HCC.
  • LEAP-012 study indicated that lenvatinib plus pembrolizumab and TACE improved median PFS to 14.6 months compared to 10.0 months with TACE alone.
  • Real-world data from the STELLAR trial supports the use of TKIs like lenvatinib for patients ineligible for or failing immunotherapy, showing manageable safety profiles.

Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)

NCT03713593CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 12/31/2018

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

A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

NCT04102098Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 12/31/2019

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

NCT03298451Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/11/2017

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

NCT04039607Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 9/30/2019

An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer

NCT01658878CompletedPhase 1
Bristol-Myers Squibb
Posted 10/30/2012

A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma

NCT02519348Active, Not RecruitingPhase 2
MedImmune LLC
Posted 10/19/2015

A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

NCT03778957Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/30/2018

A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

NCT03434379CompletedPhase 3
Hoffmann-La Roche
Posted 3/15/2018

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy

NCT03755791Active, Not RecruitingPhase 3
Exelixis
Posted 6/10/2018

A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma

NCT04763408Completed
Eisai Inc.
Posted 4/9/2021

EZH2 Enzyme Drives Drug Resistance in Prostate Cancer via Novel Mechanism

  • Researchers identified that the enzyme EZH2 shifts its function in the absence of PKCλ/ι, promoting tumor growth in aggressive prostate cancer.
  • The altered EZH2 activity activates protein synthesis and growth factors like TGF-β, fostering resistance to androgen receptor inhibitors.
  • Targeting EZH2's alternative activities or the TGF-β pathway could re-sensitize cancer cells to androgen receptor inhibitors, offering new therapeutic strategies.
  • The study suggests combining androgen receptor inhibitors with EZH2 or TGF-β inhibitors, warranting precision medicine approaches for effective treatment.

Zymeworks Receives Buy Rating Following FDA Approval of Zanidatamab for Biliary Tract Cancer

• Zymeworks received a Buy rating from Bloom Burton following FDA accelerated approval of zanidatamab for HER2-positive biliary tract cancer. • The approval allows Zymeworks to address a niche market with a rare cancer, potentially capitalizing on a first-mover advantage. • A Phase 3 confirmatory trial evaluating zanidatamab in combination with standard-of-care therapy supports potential market expansion. • Analysts anticipate peak global annual sales of zanidatamab to reach $55 million, reinforcing the Buy rating for Zymeworks' stock.

Handok's Open Innovation Strategy Drives New Drug Development and Global Expansion

• Handok Pharmaceutical has embraced open innovation since 2007, collaborating with companies like Genexine and ABL Bio to expedite new drug R&D. • The company's strategic investments, including HDB001A for biliary tract cancer, have led to Phase 2/3 trials approved by the FDA, with top-line results expected in early 2025. • Handok is also focusing on digital transformation and AI to boost productivity in clinical trials and new drug development, aiming to launch multiple new products. • With its 70th anniversary, Handok aims to solidify its position as a 'best partner' in the Korean market and expand into Southeast Asia.

Siremadlin Plus Ribociclib Shows Promise in MDM2/CDK4-Amplified Liposarcoma

• The combination of siremadlin and ribociclib demonstrates encouraging efficacy and a manageable safety profile in patients with advanced MDM2/CDK4-amplified liposarcoma. • In a subset of liposarcoma patients, the combination therapy resulted in a median overall survival of 23 months, significantly longer than historical controls. • The MEGAMOST trial suggests that targeting both MDM2 and CDK4/6 pathways may be a beneficial therapeutic approach in liposarcomas with specific genetic profiles. • The study highlights the potential of molecularly driven treatment strategies to improve outcomes in advanced solid tumors.

Functional Precision Medicine Shows Promise in Pediatric Cancer Treatment

  • A study shows functional precision medicine, combining drug sensitivity testing and genomic profiling, can guide treatment for pediatric patients with relapsed or refractory cancers.
  • The approach demonstrated improved progression-free survival and objective response rates in patients who received functionally guided treatments compared to physician's choice.
  • Functional precision medicine uses direct perturbations of tumor-derived living cells to provide personalized data for therapy, potentially impacting clinical decision-making.
  • Integrating functional precision medicine with genomics and AI could enhance the identification of novel biomarkers and personalize cancer care for individual patients.

CRISPR Therapeutics Faces Slow Casgevy Launch Despite Regulatory Approvals

• CRISPR Therapeutics' stock has declined despite FDA and EU approvals of Casgevy for sickle cell disease and transfusion-dependent beta thalassemia. • Casgevy's initial sales have been slow due to the complexity of the therapy and a conditioning regimen that carries risks. • Promising Phase 1 trial results for CTX112, a blood-cancer treatment, and a strong cash position offer potential for future growth. • Analysts suggest caution due to the high-risk nature of the stock, advising investors to consider their risk tolerance.

Ixo-Vec Gene Therapy Shows Long-Term Promise for Wet AMD in LUNA and OPTIC Trials

  • Data from the LUNA Phase 2 trial indicates that Ixo-vec (ixoberogene soroparvovec) significantly reduces treatment burden for wet AMD patients over 52 weeks.
  • The OPTIC trial's 4-year follow-up demonstrates that Ixo-vec provides long-term improvement and reduces the need for frequent anti-VEGF injections in nAMD patients.
  • A patient preference survey in LUNA revealed that approximately 93% of participants favored Ixo-vec over their prior anti-VEGF therapies, highlighting patient satisfaction.
  • Adverum Biotechnologies plans to initiate a Phase 3 trial (ARTEMIS) in the first half of 2025, comparing Ixo-vec to aflibercept for treating wet AMD.

NMDA Receptor Research Reveals Novel Mechanism for Brain Stabilization and Potential Depression Treatments

  • Researchers at Tel Aviv University have discovered that NMDA receptors (NMDARs) play a crucial role in maintaining brain stability, or homeostasis, beyond their known function in learning and memory.
  • The study suggests that ketamine's rapid antidepressant effects may stem from its ability to reset the brain's baseline activity by blocking NMDARs, offering insights into treating brain instability-related conditions.
  • Experiments on neurons, mice, and computational models demonstrated that NMDARs control baseline activity in brain networks, influencing signal transmission and reducing background noise.
  • These findings pave the way for developing targeted therapies for depression, Alzheimer’s, and epilepsy by focusing on stabilizing brain activity through NMDAR modulation.

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