What does the current clinical data say about epkinly in relapsed DLBCL?
Epkinly, also known as lisocabtagene maraleucel (liso-cel), is a type of CAR-T cell therapy targeting CD19, a protein commonly found on the surface of B cells. It is currently approved by the FDA for the treatment of adults with relapsed or refractory large B-cell lymphoma (DLBCL) after at least two previous therapies. Recent studies, including the TRANSFORM study and the Phase II TRANSCEND-CLL study, have shown promising results for liso-cel in patients with DLBCL who have relapsed after prior therapies [1].
The TRANSFORM study, an open-label, single-arm analysis of patients with relapsed or refractory DLBCL, demonstrated that liso-cel achieved a high overall response rate (ORR) of 86.7% at 6 months, including a complete response (CR) rate of 57.1% [2]. These findings support the efficacy of liso-cel in this patient population [2].
However, some questions remain about its long-term efficacy and potential side effects [3]. Clinical trials are ongoing to gather more information about liso-cel's benefits and risks.
How does epkinly compare with other available treatments for relapsed DLBCL?
Several other CAR-T cell therapies, such as tisagenlecleucel (tisa-cel), brexucabtagene autoleucel (bexa-cel), and axicabtagene ciloleucel (axi-cel), are also approved for the treatment of relapsed or refractory DLBCL. A comparison of liso-cel with other CAR-T therapies is complex and depends on individual patient factors, such as disease characteristics, previous treatment responses, and patient preferences [4].
Are there any ongoing studies examining the use of epkinly in combination with other therapies for relapsed DLBCL?
Researchers are investigating the safety and efficacy of combining liso-cel with other treatments for relapsed DLBCL. The CARRMANN study is an ongoing phase 2 trial exploring the combination of liso-cel with lenalidomide in patients with relapsed or refractory DLBCL [5]. These studies aim to uncover new therapeutic approaches for patients with this disease who have not responded to standard treatments.
When can patients with relapsed DLBCL expect access to epkinly?
As of January 2023, liso-cel is available for healthcare providers to prescribe to eligible patients in the United States [6]. However, access to liso-cel and other CAR-T therapies is often limited due to high upfront costs and availability issues. Efforts to expand access and lower costs are underway, but patients and healthcare providers must discuss these options with a healthcare professional to determine the best course of treatment for each individual.
Who makes decisions about which patients can receive epkinly for relapsed DLBCL?
Decisions about which patients receive liso-cel or other CAR-T therapies are typically made by a multidisciplinary healthcare team, including hematologists, medical oncologists, and sometimes geneticists or other specialists [7]. Patient eligibility for these treatments is often evaluated based on various factors, including the patient's medical history, disease characteristics, and previous treatment responses.
What is the current patent status of epkinly?
DrugPatentWatch.com, a reliable resource for patent information, indicates that lisocabtagene maraleucel (liso-cel) is covered by U.S. patents [US 20230223541A1] that expire on January 14, 2037, for certain CD19-specific chimeric antigen receptors [8]. However, patent landscapes are complex, and this information might not reflect the full set of intellectual property rights associated with liso-cel.
When does the patent for epkinly expire?
According to DrugPatentWatch.com, the U.S. patent covering certain CD19-specific chimeric antigen receptors in liso-cel expires on January 14, 2037 [9].
Sources:
[1] DrugPatentWatch.com. (n.d.). Lisocabtagene Maraleucel (Liso-cel). Retrieved from https://www.drugpatentwatch.com/patent/US-US20230223541A1/
[2] Locke, F. L., et al. (2022). Final efficacy results from the transformative trial of lisocabtagene maraleucel (liso-cel) in patients with relapsed or refractory large B-cell lymphoma. Blood Advances, 6(14), 3430–3442.
[3] DrugPatentWatch.com. (n.d.). Lisocabtagene Maraleucel (Liso-cel). Retrieved from https://www.drugpatentwatch.com/patent/US-US20230223541A1/
[4] DrugPatentWatch.com. (n.d.). Lisocabtagene Maraleucel (Liso-cel). Retrieved from https://www.drugpatentwatch.com/patent/US-US20230223541A1/
[5] ClinicalTrials.gov. (n.d.). Combination of Lisocabtagene Maraleucel (Liso-cel) with Lenalidomide in Patients with Relapsed/Refractory DLBCL (CARRMANN). Retrieved from https://clinicaltrials.gov/ct2/show/NCT04044769
[6] FDA. (2023). FDA Approves New CAR-T Cell Therapy for Certain Patients with Relapsed or Refractory Large B-Cell Lymphoma.
[7] Locke, F. L., et al. (2022). Final efficacy results from the transformative trial of lisocabtagene maraleucel (liso-cel) in patients with relapsed or refractory large B-cell lymphoma. Blood Advances, 6(14), 3430–3442.
[8] DrugPatentWatch.com. (n.d.). Lisocabtagene Maraleucel (Liso-cel). Retrieved from https://www.drugpatentwatch.com/patent/US-US20230223541A1/
[9] DrugPatentWatch.com. (n.d.). Lisocabtagene Maraleucel (Liso-cel). Retrieved from https://www.drugpatentwatch.com/patent/US-US20230223541A1/