Clinical Trial News
Omission of Axillary Lymph Node Dissection in Breast Cancer Patients with Residual Nodal Disease After Neoadjuvant Chemotherapy
A study evaluating the impact of omitting axillary lymph node dissection (ALND) on oncological outcomes in breast cancer patients with residual nodal disease after neoadjuvant chemotherapy (NAC) found that sentinel lymph node biopsy (SLNBx) alone did not compromise oncological outcomes. The research suggests that the omission of ALND might be a viable option for axillary management in patients treated with NAC and postoperative radiotherapy.
Aducanumab Approval and Medicare Coverage: Implications for Alzheimer's Treatment
- The FDA's approval of aducanumab, an antiamyloid antibody for early Alzheimer's, sparked controversy due to unclear clinical benefits and high cost.
- CMS restricted Medicare coverage to patients in clinical trials, citing limited evidence and significant adverse effects, creating access barriers.
- Cost-effectiveness analyses suggest aducanumab's price is not justified by its clinical benefits, with ARIA-related costs adding to the financial burden.
- The aducanumab case impacts future Alzheimer's drug development, approval standards, and Medicare coverage policies for antiamyloid therapies.
Insilico Medicine's AI-Designed COVID-19 Drug Enters Clinical Trials
- Insilico Medicine's ISM3312, an AI-designed therapeutic, has entered clinical trials in China after promising preclinical results.
- The drug targets the 3CLpro protease in SARS-CoV-2, potentially effective against current and future variants and other coronaviruses.
- Preclinical studies showed ISM3312 significantly reduces viral load and lung inflammation, offering a potential advantage over existing treatments.
- While promising, experts caution that it is still early to determine the drug's safety and efficacy in humans.
Socazolimab Plus Chemotherapy Shows Promise in Extensive-Stage Small Cell Lung Cancer
- A Phase 1b trial indicates that socazolimab, combined with etoposide and carboplatin, demonstrates potential survival benefits in treating extensive-stage small cell lung cancer (ES-SCLC).
- The study reported a median progression-free survival (PFS) of 5.65 months and a median overall survival (OS) of 14.88 months in ES-SCLC patients.
- Socazolimab's immunogenicity was evaluated, revealing a higher incidence of antidrug antibodies (ADAs) compared to other PD-1/PD-L1 inhibitors, though without significant impact on safety or response.
- The safety profile of socazolimab combined with chemotherapy was manageable, with most grade 3 or 4 treatment-related adverse events (TRAEs) occurring during the combination treatment period.
Highlighted Clinical Trials:
Lee's Pharmaceutical Limited
Posted 3/8/2020
Qilu Pharmaceutical Co., Ltd.
Posted 4/18/2022
Lee's Pharmaceutical Limited
Posted 7/15/2021
Innovent Biologics (Suzhou) Co. Ltd.
Posted 9/7/2021
Ultragenyx's UX111 Gene Therapy Shows Sustained Efficacy in MPS IIIA Patients
- UX111, an AAV9-based gene therapy, demonstrates rapid and sustained reduction of cerebrospinal fluid biomarker levels in MPS IIIA patients treated early.
- A phase 1/2/3 clinical trial (Transpher A) showed dose-dependent efficacy, with the highest dose cohort (3 x 10^13 vg/kg) exhibiting the most significant biomarker reduction.
- The gene therapy has shown neurodevelopmental gains in treated patients, with no drug-related serious adverse events reported in the trial.
- UX111, acquired by Ultragenyx from Abeona Therapeutics, has received multiple designations, including regenerative medicine advanced therapy and orphan drug status.
Highlighted Clinical Trials:
Follow-up Study of AAV-Mediated Gene Transfer (UX111; Previously Known as ABO-102) for MPS Type IIIA
Ultragenyx Pharmaceutical Inc
Posted 9/28/2020
Ultragenyx Pharmaceutical Inc
Posted 4/25/2016
Survival Outcomes in BRAF V600E-Mutated Advanced Colorectal Cancer: Chemotherapy Alone vs. Chemotherapy Combined with Bevacizumab
A study comparing the survival outcomes of patients with BRAF V600E-mutated advanced colorectal cancer (CRC) treated with chemotherapy alone versus chemotherapy combined with bevacizumab found no significant difference in overall survival (OS) and progression-free survival (PFS) between the two groups. The research highlights the need for new treatment options for this patient population, as current therapies do not significantly improve survival rates.
Highlighted Clinical Trials:
Pierre Fabre Medicament
Posted 1/17/2019
Pfizer
Posted 12/21/2020
Avutometinib Plus Defactinib Shows Promise in Recurrent Low-Grade Serous Ovarian Cancer
- The combination of avutometinib and defactinib demonstrated a 28% confirmed objective response rate in patients with recurrent low-grade serous ovarian cancer.
- Patients with both KRAS-mutated and KRAS wild-type disease showed similar response rates of 27% and 29%, respectively, when treated with the combination therapy.
- The disease control rate with the combination therapy was notably high at 93%, with a significant proportion of patients remaining on treatment after 5 months.
- Verastem Oncology plans to use data from the RAMP-201 and FRAME trials to potentially support accelerated approval of avutometinib plus defactinib.
Highlighted Clinical Trials:
Verastem, Inc.
Posted 12/21/2020
Institute of Cancer Research, United Kingdom
Posted 12/12/2017
Methadone vs. Buprenorphine: Landmark Trial to Evaluate Opioid Addiction Treatments in Fentanyl Era
- A new clinical trial will compare methadone and buprenorphine for opioid addiction treatment in office settings, a first in the fentanyl era.
- The study addresses the need for expanded methadone access, as buprenorphine is proving less effective for some patients amid the opioid crisis.
- Researchers will assess patient retention in treatment when methadone is prescribed in primary care, potentially changing access policies.
- The trial anticipates increased flexibility in methadone access, aiming to inform clinical decisions if office-based dispensing becomes available.
Metformin's Repurposing as Cancer Therapeutic: New Avenues and Future Directions
- Recent trials show limited efficacy of metformin as a treatment for established cancers, leading to a decline in enthusiasm for further clinical studies.
- Emerging data suggests potential for metformin in combination with immunotherapy by remodeling the hypoxic tumor microenvironment and enhancing tumor immunosurveillance.
- Studies indicate metformin's role in cancer prevention, particularly in high-risk populations like those with Li-Fraumeni syndrome, warranting further clinical investigation.
- Future research should focus on patient selection, understanding the mechanism of action, and identifying appropriate drug combinations to maximize metformin's therapeutic potential.
Promius Pharma Advances Minocycline Hydrochloride ER Development for Rosacea Treatment
- Promius Pharma, a Dr. Reddy's Laboratories subsidiary, is developing an extended-release formulation of minocycline hydrochloride for treating rosacea, expanding their dermatology portfolio.
- The company leverages its expertise in dermatological products and R&D capabilities through their Princeton-based laboratories for product ideation, formulation, and testing.
- This development represents a potential new treatment option for rosacea patients, adding to Promius Pharma's existing line of dermatology solutions including clocortolone pivalate and promiseb topical cream.