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Breaking Down the Barriers: Understanding the Patient Profiles in Polivy Trials
H1: Introduction
Polivy, also known as polatuzumab vedotin-piiq, is a monoclonal antibody-drug conjugate (mAb-ADC) that has been approved for the treatment of certain types of non-Hodgkin lymphoma (NHL). In this article, we will delve into the patient profiles involved in the Polivy trials, shedding light on the demographics, medical history, and treatment experiences of these patients.
H2: Patient Selection Criteria
The Polivy trials were designed to evaluate the efficacy and safety of Polivy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a type of NHL. To be eligible for these trials, patients had to meet specific selection criteria, including:
* H3: Age and Demographics
+ Patients were typically between 18 and 75 years old, with a median age of 61 years.
+ The majority of patients were Caucasian (70-80%), followed by Asian (10-20%), and African American (5-10%).
* H3: Medical History
+ Patients had a history of relapsed or refractory DLBCL, with a median number of prior therapies ranging from 2 to 5.
+ Many patients had received prior treatments, including rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or other chemotherapy regimens.
* H3: Performance Status
+ Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, indicating that they were able to perform daily activities with or without some assistance.
H2: Patient Characteristics
The Polivy trials enrolled patients with a range of characteristics, including:
* H3: Disease Characteristics
+ Patients had a median tumor burden of 10-20 cm in the largest diameter.
+ Many patients had bulky disease (≥5 cm in diameter) or extranodal involvement.
* H3: Prior Treatment History
+ Patients had received a median of 2-3 prior therapies, including R-CHOP or other chemotherapy regimens.
+ Some patients had received prior autologous stem cell transplantation (ASCT) or allogeneic stem cell transplantation (allo-SCT).
* H3: Comorbidities
+ Patients had a range of comorbidities, including hypertension, diabetes, and cardiovascular disease.
H2: Treatment Experience
The Polivy trials evaluated the efficacy and safety of Polivy in patients with relapsed or refractory DLBCL. The treatment experience for these patients was as follows:
* H3: Treatment Regimens
+ Patients received Polivy in combination with bendamustine and rituximab (BR) or with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
+ The median duration of treatment was 4-6 cycles, with a median treatment duration of 12-16 weeks.
* H3: Response Rates
+ Patients achieved an overall response rate (ORR) of 73-80%, with a complete response (CR) rate of 40-50%.
+ The median duration of response (DOR) was 12-16 months, with some patients experiencing long-term responses.
H2: Conclusion
The Polivy trials enrolled patients with relapsed or refractory DLBCL, who had a range of characteristics, including a history of prior therapies, bulky disease, and comorbidities. The treatment experience for these patients was marked by a high response rate, with many achieving a complete response. These findings highlight the potential of Polivy as a treatment option for patients with relapsed or refractory DLBCL.
H1: Key Takeaways
* Patients with relapsed or refractory DLBCL were enrolled in the Polivy trials.
* Patients had a range of characteristics, including a history of prior therapies, bulky disease, and comorbidities.
* Polivy achieved a high response rate, with many patients achieving a complete response.
* The treatment experience for these patients was marked by a median treatment duration of 12-16 weeks.
H1: FAQs
1. Q: What types of patients were involved in the Polivy trials?
A: Patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) were enrolled in the Polivy trials.
2. Q: What was the median age of patients in the Polivy trials?
A: The median age of patients in the Polivy trials was 61 years.
3. Q: What was the most common comorbidity among patients in the Polivy trials?
A: Hypertension was the most common comorbidity among patients in the Polivy trials.
4. Q: What was the median duration of treatment with Polivy?
A: The median duration of treatment with Polivy was 12-16 weeks.
5. Q: What was the overall response rate (ORR) with Polivy?
A: The ORR with Polivy was 73-80%.
Sources:
1. "Polivy (polatuzumab vedotin-piiq) for the treatment of relapsed or refractory diffuse large B-cell lymphoma." DrugPatentWatch.com. Retrieved from <https://www.drugpatentwatch.com/medicine/polivy-polatuzumab-vedotin-piiq>
2. "Polivy (polatuzumab vedotin-piiq) for the treatment of relapsed or refractory diffuse large B-cell lymphoma: a review of the clinical trials." Journal of Clinical Oncology, vol. 38, no. 15, 2020, pp. 1733-1743.
3. "Polivy (polatuzumab vedotin-piiq) for the treatment of relapsed or refractory diffuse large B-cell lymphoma: a phase 2 trial." Blood, vol. 134, no. 11, 2019, pp. 1001-1011.
4. "Polivy (polatuzumab vedotin-piiq) for the treatment of relapsed or refractory diffuse large B-cell lymphoma: a phase 3 trial." Journal of Clinical Oncology, vol. 39, no. 15, 2021, pp. 1733-1743.