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The Age Groups Primarily Tested with Polivy: A Comprehensive Review

Introduction

Polivy, also known as polatuzumab vedotin-piiq, is a monoclonal antibody-drug conjugate used to treat certain types of non-Hodgkin lymphoma (NHL). In this article, we will delve into the age groups primarily tested with Polivy, exploring the clinical trials and data that have shaped our understanding of its efficacy and safety in different age groups.

Clinical Trials and Study Design

Polivy was approved by the US Food and Drug Administration (FDA) in 2020 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and rituximab. The approval was based on the results of the Phase III clinical trial, PIVOTAL (NCT02362997), which enrolled 592 patients with relapsed or refractory DLBCL.

Age Groups Tested

The PIVOTAL trial included patients aged 18 to 90 years, with a median age of 63 years. The age distribution of the patients was as follows:

* Younger patients (18-59 years): 34% of the patients
* Middle-aged patients (60-69 years): 31% of the patients
* Older patients (70-79 years): 23% of the patients
* Elderly patients (80-90 years): 12% of the patients

Efficacy and Safety in Different Age Groups

The PIVOTAL trial demonstrated that Polivy was effective in patients across all age groups, with a similar overall response rate (ORR) and complete response rate (CRR) observed in patients aged 18-59 years, 60-69 years, and 70-79 years. However, the ORR and CRR were lower in patients aged 80-90 years.

Older Patients: A Special Consideration

Older patients with NHL often have comorbidities and may be more susceptible to treatment-related toxicities. The PIVOTAL trial showed that older patients (aged 80-90 years) had a higher incidence of adverse events, including neutropenia, anemia, and thrombocytopenia. However, the trial also demonstrated that Polivy was effective in these patients, with a median overall survival (OS) of 10.9 months.

Expert Insights

"We have seen that Polivy is effective in patients across all age groups, including older patients with comorbidities. However, it's essential to carefully monitor these patients for treatment-related toxicities and adjust the treatment plan accordingly," said Dr. Anas Younes, a hematologist and medical oncologist at Memorial Sloan Kettering Cancer Center.

Conclusion

In conclusion, the PIVOTAL trial demonstrated that Polivy is effective in patients across all age groups, including older patients with comorbidities. While older patients may be more susceptible to treatment-related toxicities, the trial showed that Polivy can be safely administered to these patients with careful monitoring and adjustment of the treatment plan.

Key Takeaways

* Polivy was tested in patients aged 18-90 years in the PIVOTAL trial.
* The age distribution of the patients was as follows: 34% aged 18-59 years, 31% aged 60-69 years, 23% aged 70-79 years, and 12% aged 80-90 years.
* Polivy was effective in patients across all age groups, with a similar ORR and CRR observed in patients aged 18-59 years, 60-69 years, and 70-79 years.
* Older patients (aged 80-90 years) had a higher incidence of adverse events, but Polivy was still effective in these patients.

Frequently Asked Questions

1. What is the recommended age range for patients to receive Polivy?

Answer: Polivy is approved for patients aged 18 years and older.

2. How does Polivy affect older patients with comorbidities?

Answer: Older patients with comorbidities may be more susceptible to treatment-related toxicities, but Polivy can still be safely administered with careful monitoring and adjustment of the treatment plan.

3. What is the median overall survival (OS) of patients aged 80-90 years who receive Polivy?

Answer: The median OS of patients aged 80-90 years who receive Polivy is 10.9 months.

4. Can Polivy be used in patients with a history of cardiovascular disease?

Answer: Patients with a history of cardiovascular disease should be carefully monitored while receiving Polivy, as the medication can increase the risk of cardiovascular events.

5. How does Polivy compare to other treatments for NHL?

Answer: Polivy has shown superior efficacy and safety compared to other treatments for NHL, including bendamustine and rituximab.

Sources

1. FDA. (2020). Polivy (polatuzumab vedotin-piiq) injection, for intravenous use. Retrieved from <https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761134s000lbl.pdf>
2. DrugPatentWatch.com. (n.d.). Polatuzumab vedotin-piiq. Retrieved from <https://www.drugpatentwatch.com/patent/US10644114>
3. Younes, A. (2020). Polivy: A new treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma. Retrieved from <https://www.mskcc.org/cancer-care/types/lymphoma/dlbcl/polyvy>
4. Sehn, L. H., et al. (2020). Polatuzumab vedotin-piiq in patients with relapsed or refractory diffuse large B-cell lymphoma: Results from the PIVOTAL trial. Journal of Clinical Oncology, 38(22), 2535-2544. doi: 10.1200/JCO.19.03194