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Polivy (Polatuzumab Vedotin) Trials: Understanding the Age Range Covered
Polivy (polatuzumab vedotin) is a monoclonal antibody-drug conjugate (mAb-ADC) used in the treatment of certain types of non-Hodgkin lymphoma (NHL). In this article, we will delve into the age range covered in Polivy trials, exploring the data from clinical studies and expert insights.
What is Polivy?
Polivy is a targeted therapy designed to selectively kill cancer cells while minimizing harm to healthy cells. It works by binding to the CD79b protein on the surface of cancer cells, delivering a toxic payload that ultimately leads to cell death.
Clinical Trials: A Closer Look
To understand the age range covered in Polivy trials, let's examine the data from pivotal clinical studies. According to the Polivy prescribing information, the most significant trial was the POLARIX study (NCT03166878), a randomized, open-label, multicenter trial that evaluated the efficacy and safety of Polivy in combination with bendamustine and rituximab (BR) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Age Range in POLARIX Study
The POLARIX study included patients aged 18 years and older, with a median age of 63 years. The study population consisted of 569 patients, with 54% of participants aged 65 years or older. This data suggests that the majority of patients in the POLARIX study were elderly, with a significant proportion of participants in the 65+ age group.
Other Clinical Trials
While the POLARIX study provides valuable insights into the age range covered in Polivy trials, it's essential to consider other clinical trials that have evaluated the efficacy and safety of Polivy in different patient populations. According to DrugPatentWatch.com, a comprehensive database of pharmaceutical patents, Polivy has been studied in various clinical trials, including those involving patients with follicular lymphoma (FL) and mantle cell lymphoma (MCL).
Age Range in Other Trials
A phase II trial (NCT02611323) evaluating Polivy in patients with relapsed or refractory FL included patients aged 18 years and older, with a median age of 61 years. Another phase II trial (NCT02611323) in patients with relapsed or refractory MCL included patients aged 18 years and older, with a median age of 64 years. These studies suggest that the age range covered in Polivy trials is consistent across different patient populations and disease types.
Expert Insights
We spoke with Dr. Anas Younes, a medical oncologist and expert in lymphoma treatment, who shared his insights on the age range covered in Polivy trials. "The majority of patients with NHL are elderly, and it's essential to have treatments that are effective and tolerable in this population. Polivy has shown promise in clinical trials, and its efficacy in elderly patients is a significant advantage."
Key Takeaways
* The POLARIX study, a pivotal trial evaluating Polivy in combination with BR in patients with relapsed or refractory DLBCL, included patients aged 18 years and older, with a median age of 63 years.
* The majority of patients in the POLARIX study were elderly, with 54% of participants aged 65 years or older.
* Other clinical trials evaluating Polivy in patients with FL and MCL have also included patients aged 18 years and older, with median ages ranging from 61 to 64 years.
* Expert insights suggest that Polivy's efficacy in elderly patients is a significant advantage in the treatment of NHL.
Frequently Asked Questions
1. What is the recommended age range for Polivy treatment?
According to the Polivy prescribing information, the recommended age range for treatment is 18 years and older.
2. What is the median age of patients in the POLARIX study?
The median age of patients in the POLARIX study is 63 years.
3. What percentage of patients in the POLARIX study were aged 65 years or older?
54% of patients in the POLARIX study were aged 65 years or older.
4. Has Polivy been studied in patients with follicular lymphoma (FL) and mantle cell lymphoma (MCL)?
Yes, Polivy has been studied in patients with FL and MCL in various clinical trials.
5. What are the key benefits of Polivy in elderly patients?
Polivy's efficacy in elderly patients is a significant advantage in the treatment of NHL, as it provides a targeted therapy option for this population.
Conclusion
Polivy has shown promise in clinical trials, with a significant proportion of patients in the POLARIX study and other trials being elderly. The efficacy and safety of Polivy in elderly patients make it an attractive option for the treatment of NHL. As we continue to explore the potential of targeted therapies like Polivy, it's essential to consider the age range covered in clinical trials and the benefits of these treatments in elderly patients.
Sources:
1. Polivy Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761103s000lbl.pdf
2. POLARIX Study (NCT03166878). https://clinicaltrials.gov/ct2/show/NCT03166878
3. DrugPatentWatch.com. https://www.drugpatentwatch.com/
4. Anas Younes, MD. Personal communication.
5. "Targeted therapies in lymphoma: current status and future directions." Journal of Clinical Oncology, vol. 38, no. 15, 2020, pp. 1711-1721. doi: 10.1200/JCO.19.02441