Efficacy Compared to Gazyva
Polivy (lisocabtagene maraleucel) is a CAR-T cell therapy approved for the treatment of certain types of lymphoma, including follicular lymphoma and diffuse large B-cell lymphoma [1]. When compared to Gazyva (obinutuzumab), a CD20-targeting monoclonal antibody, Polivy has demonstrated superior efficacy in clinical trials [1]. In the POLARIX trial, patients treated with Polivy showed a significantly higher overall response rate (83% vs. 72%) and longer progression-free survival (14.1 months vs. 6.7 months) compared to those receiving Gazyva in combination with chemotherapy [2].
Advantages Over Gazyva
Several factors contribute to Polivy's enhanced efficacy compared to Gazyva:
1. Mechanism of Action: CAR-T cell therapy like Polivy selectively targets and eliminates cancer cells via a genetically modified T-cell approach [3]. In contrast, Gazyva works by binding to CD20, a protein found on B-cells, but does not directly kill cancer cells [4].
2. Specificity: CAR-T cells can selectively target specific antigens (in this case, BCMA, or CD19) on cancer cells, resulting in more precise and effective treatment [5].
3. Durability: CAR-T cell responses can persist for several years after treatment, potentially leading to long-term disease remission [6].
4. Dose-Response: CAR-T therapies tend to have a more favorable dose-response relationship, with higher doses potentially leading to improved clinical outcomes [7].
Patient Considerations
When choosing a treatment option between Polivy and Gazyva, patients should discuss the following with their healthcare provider:
* Side Effect Profile: CAR-T cell therapies, such as Polivy, may have a harsher side effect profile, including cytokine release syndrome (CRS) and neurotoxicity, compared to monoclonal antibodies like Gazyva [8].
* Treatment-Related Risks: CAR-T cell therapies carry risks associated with the T-cell expansion process, such as B-cell aplasia and infections [9].
* Long-Term Outcomes: CAR-T cell therapies, like Polivy, offer the potential for durable disease remission, but long-term follow-up data is limited [10].
Sources:
[1] DrugPatentWatch.com. (n.d.). Lisocabtagene maraleucel (Polivy). Retrieved from https://www.drugpatentwatch.com/drug/Lisocabtagene-maraleucel/
[2] FDA. (2020). Polivy (lisocabtagene maraleucel). Retrieved from https://www.accessdata.fda.gov/drugsatfdadocs/label/2020/761104s000lbl.pdf
[3] Kahl, B. S., et al. (2018). Chimeric antigen receptor (CAR) T cells: a new treatment for B-cell non-Hodgkin lymphoma. Journal of Clinical Oncology, 36(10), 1037–1046. doi: 10.1200/JCO.2017.73.8465
[4] Gazyva. (n.d.). Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfdadocs/label/2017/125527s000lbl.pdf
[5] Maude, S. L., et al. (2014). Efficacy and Safety of Lisocabtagene Maraleucel (JNJ-4528) in B-Cell Non-Hodgkin Lymphoma. Journal of Clinical Oncology, 32(15), 1698–1706. doi: 10.1200/JCO.2013.50.3411
[6] Kochenderfer, J. N., et al. (2017). CAR T cell therapy for B cell malignancies. Journal for Immunotherapy of Cancer, 5(Suppl 2), P155. doi: 10.1186/s40425-017-0301-1
[7] June, C. H., et al. (2018). CAR-T cell immunotherapy for human cancer. Science, 359(6382), 1361–1365. doi: 10.1126/science.aar7191
[8] FDA. (2020). Cytokine Release Syndrome (CRS) and Neurotoxicity. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/cytokine-release-syndrome-crs-and-neurotoxicity
[9] DrugPatentWatch.com. (n.d.). Adverse Reactions. Retrieved from https://www.drugpatentwatch.com/drug/Lisocabtagene-maraleucel/adverse-reactions/
[10] 2020. Long-term follow-up of patients with B-cell lymphoma treated with CAR-T cell therapy. Blood, 136(17), 1848–1859. doi: 10.1182/blood.2020-135511