Clinical Trial News
ROCK2 Inhibition With Belumosudil (KD025) Shows Promise in Treating Chronic Graft-Versus-Host Disease
A phase IIa study on belumosudil (KD025), a selective ROCK2 inhibitor, demonstrated significant efficacy in treating chronic graft-versus-host disease (cGVHD), with high overall response rates, quality-of-life improvements, corticosteroid dose reductions, and limited toxicity. The study involved 54 patients with cGVHD who had received one to three prior lines of therapy, showing promising results across various doses.
Highlighted Clinical Trials:
Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
Kadmon, a Sanofi Company
Posted 10/11/2018
Kadmon, a Sanofi Company
Posted 9/15/2016
FDA Grants Orphan Drug Status to Novel IRAK4 Inhibitor for AML and MDS Treatment
The FDA has granted orphan drug designation to CA-4948, a novel IRAK4 inhibitor, for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). This designation marks a significant step in developing a disease-modifying treatment for these rare hematological malignancies. CA-4948 is currently under investigation in a phase 1 clinical trial to determine its safety and efficacy.
Highlighted Clinical Trials:
Curis, Inc.
Posted 7/6/2020
FDA Revokes Emergency Use Authorization for Bamlanivimab Monotherapy Against COVID-19
• The FDA revoked the EUA for bamlanivimab monotherapy due to increasing SARS-CoV-2 variants resistant to the treatment, raising the risk of treatment failure.
• Data from the CDC showed a significant increase in resistant variants, from 5% in mid-January to approximately 20% in mid-March 2021.
• Alternative monoclonal antibody therapies, such as REGEN-COV and bamlanivimab with etesevimab, remain available under EUA for COVID-19 treatment.
• The FDA emphasizes the importance of using monoclonal antibody therapies effective against prevalent variants to minimize treatment failure in high-risk patients.
Real-World Study Confirms Lyme Vaccine Effectiveness Before Market Withdrawal
• A matched case-control study assessed the real-world effectiveness of the Lyme vaccine (LYMErix) before its market withdrawal in 2002.
• The study found that three or more doses of the LYMErix vaccine were 71% effective in preventing Lyme disease in clinical practice.
• This research provides the first evidence of the Lyme vaccine's effectiveness in a real-world setting, mirroring prelicensure clinical trial efficacy.
• The findings highlight the potential public health benefit that was lost when the vaccine was discontinued, given the rise in Lyme disease cases.
FDA Approves Ide-cel CAR T-Cell Therapy for Relapsed or Refractory Multiple Myeloma
• The FDA has approved idecabtagene vicleucel (Abecma), a CAR T-cell therapy, for multiple myeloma patients who have not responded to or relapsed after at least four prior lines of therapy.
• Clinical trial results showed a 72% overall response rate with ide-cel, including complete remissions in 28% of patients, offering a significant improvement over existing treatments.
• Ide-cel targets BCMA, a protein highly expressed in multiple myeloma cells, using genetically engineered T cells to enhance the immune system's ability to eliminate cancer cells.
• The treatment carries risks of serious side effects, including cytokine release syndrome and neurotoxicity, requiring specialized training and monitoring for healthcare providers.
NCCN Announces Projects to Study Oral Decitabine and Cedazuridine
The National Comprehensive Cancer Network (NCCN) Oncology Research Program has selected three projects to study the combination of oral decitabine and cedazuridine, aiming to explore its potential in tumor suppression. The studies, funded by Taiho Oncology, will commence in 2021 and focus on various cancer treatments, including AML relapse, androgen pathway inhibitors, and immune checkpoint blockade in melanoma.
Neoadjuvant Chemohormonal Therapy Before Radical Prostatectomy for High-Risk Prostate Cancer
A study evaluated the feasibility and safety of neoadjuvant chemohormonal therapy (NCHT) before radical prostatectomy (RP) for Japanese patients with high-risk localized prostate cancer (PCa). The study found NCHT to be safe and feasible, with a significant difference in biochemical progression-free survival (bPFS) between very high-risk (VHR) and not very high-risk (nVHR) groups. However, more extensive treatment modalities are needed to improve outcomes, especially in VHR patients.
Pfizer's Sasanlimab-BCG Combination Shows Significant Improvement in High-Risk Bladder Cancer Trial
• Pfizer's phase III CREST trial demonstrated that sasanlimab, an anti-PD-1 monoclonal antibody, in combination with BCG therapy significantly improved outcomes in patients with high-risk non-muscle invasive bladder cancer.
• The combination therapy was evaluated as both induction therapy and with maintenance treatment in BCG-naïve patients, showing promising results for this difficult-to-treat patient population.
• This development follows similar positive results from AstraZeneca's POTOMAC trial, where Imfinzi (durvalumab) plus BCG therapy showed statistically significant improvement in disease-free survival compared to BCG alone.
Controversy Surrounds FDA Approval of Pembrolizumab for High TMB Solid Tumors
A recent analysis has sparked controversy over the FDA's accelerated approval of pembrolizumab for treating solid tumors with a high tumor mutational burden (TMB), citing concerns over the broadness of the approval criteria and the neglect of survival data in certain tumor types. The approval was based on the KEYNOTE-158 study, which showed a 29% overall response rate in patients with TMB greater than 10 mutations per megabase, but critics argue it overlooks more meaningful clinical endpoints like survival and quality of life.
Highlighted Clinical Trials:
Merck Sharp & Dohme LLC
Posted 12/18/2015
Advancements in PSMA-Targeted Radionuclide Therapy for Metastatic Prostate Cancer
• PSMA-PET imaging with small molecule delivery of radionuclides is effective for defining intra-prostatic and metastatic prostate cancer, especially at low PSA levels.
• 177Lu-PSMA-617 has shown promising results in mCRPC treatment, with studies reporting significant PSA decline and manageable toxicities.
• The TheraP study demonstrated that 177Lu-PSMA-617 achieved a higher PSA response rate compared to cabazitaxel chemotherapy in mCRPC patients.
• The ongoing phase III VISION trial is evaluating 177Lu-PSMA-617 plus standard of care versus standard of care alone for radiographic progression-free and overall survival in mCRPC.
Highlighted Clinical Trials:
Weill Medical College of Cornell University
Posted 12/1/2016
Peter MacCallum Cancer Centre, Australia
Posted 4/21/2020
Memorial Sloan Kettering Cancer Center
Posted 1/19/2017