Hulyo 25, 2021: Ang Kite, isang Kumpanya ng Galaad (Nasdaq: GILD), ngayon ay inihayag na binigyan ng FDA ang TecartusTM (brexucabtagene autoleucel, dating KTE-X19), ang una at naaprubahan lamang receptor ng chimeric antigen na CAR T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, accelerated approval (MCL). The FDA granted priority review and breakthrough therapy designation to this one-time therapy, which was based on the results of ZUMA-2, a single-arm, open-label study in which 87 percent of patients responded to a single infusion of Tecartus, with 62 percent achieving a complete response (CR). 18% of patients who were evaluated for safety had cytokine release syndrome (CRS) of Grade 3 or higher, and 37% had neurologic toxicities of Grade 3 or higher.
“Despite promising advances, there are still significant gaps in treatment for MCL patients who progress after initial therapy,” said Michael Wang, MD, ZUMA-2 Lead Investigator and Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center. “Many patients have high-risk disease, which means they are more likely to progress despite treatment. “Tecartus is the first cell therapy available to people with relapsed or refractory MCL. It has an impressive response rate of nearly 90% and early clinical evidence suggests that remissions may last through later lines of therapy. This makes it an important choice for these patients.”
"Ipinagmamalaki namin na ilunsad ang aming pangalawang cell therapy dahil ang Kite ay nakatuon sa pagdala ng Ang therapy ng CAR T to patients with haematological cancers,” said Christi Shaw, Kite’s Chief Executive Officer. “I would like to express my gratitude to the patient study participants, caregivers, clinical researchers, regulators, and dedicated Kite colleagues who contributed to this approval, and we look forward to working with the lymphoma community to bring this potentially transformative therapy to patients with relapsed or refractory MCL.”
Tecartus’ product label includes a boxed warning about the risks of CRS and neurologic toxicities. The FDA has approved a Risk Evaluation and Mitigation Strategy (REMS) for Tecartus, which has been combined with the REMS for Yescarta® (axicabtagene ciloleucel). The REMS programme will inform and educate healthcare professionals about the risks associated with Tecartus therapy, and training and certification in the REMS programme will be a requirement for centres offering Tecartus therapy to receive final authorization.
Ang MCL ay isang bihirang uri ng non-Hodgkin lymphoma (NHL) na nabubuo mula sa mga selula sa "mantle zone" ng lymph node at pangunahing nakakaapekto sa mga lalaki sa edad na 60. Kasunod ng pagbabalik, ang MCL ay lubhang agresibo, at maraming mga pasyente ang umuunlad pagkatapos ng paggamot.
The Lymphoma Research Foundation’s Chief Executive Officer, Meghan Gutierrez, said, “This approval marks the first CAR T cell therapy approved for mantle cell lymphoma patients and represents a new frontier in the treatment of this disease.” “Researchers have made significant progress in our understanding of this disease over the last decade, and we’ve seen an increase in patient clinical trials, which we hope will continue to improve treatment strategies and options for people with mantle cell lymphoma. Today’s news builds on that progress and gives mantle cell patients and their families reason to be hopeful.”
Kite’s commercial manufacturing facility in El Segundo, California, will produce Tecartus. Kite achieved a 96 percent manufacturing success rate in the ZUMA-2 trial, with a median manufacturing turnaround time of 15 days from leukapheresis to product delivery. Patients with advanced disease, who are severely ill and at risk of rapid progression, require manufacturing speed in particular.
Ang Kite Konnect®, isang pinagsamang platform ng teknolohiya na nagbibigay ng impormasyon at tulong sa buong proseso ng therapy para sa komersyalisado ng Kite Mga therapies sa CAR T, including courier tracking for shipments and manufacturing status updates, is available to patients whose healthcare professionals have prescribed Tecartus therapy. Kite Konnect is a support system for patients who are receiving Yescarta or Tecartus, as well as information for the healthcare teams who are supporting them.
KTE-X19 ay kasalukuyang sinusuri sa European Union, at binigyan ito ng European Medicines Agency ng Priority Medicines (PRIME) na pagtatalaga para sa relapsed o repraktoryong MCL.
Mga resulta sa pagsubok sa Tecartus
The approval of Tecartus is based on results from the ongoing ZUMA-2 pivotal trial, which is a single arm, open-label study. 74 adult patients with relapsed or refractory MCL who had previously received anthracycline- or bendamustine-containing chemotherapy, anti-CD20 antibody treatment, or a Bruton tyrosine kinase inhibitor were enrolled in the trial (ibrutinib or acalabrutinib). The primary endpoint was the objective response rate (ORR), which was defined as the combined rate of CR and partial responses as judged by an Independent Radiologic Review Committee according to the Lugano Classification (2014). (IRRC).
Sa pananaliksik, 87 porsyento ng mga pasyente (n = 60 nasusuri para sa pagsusuri ng espiritu) ang gumanti sa isang solong pagbubuhos ng Tecartus, na may 62 porsyento na nakakamit ang isang kumpletong tugon. Ang follow-up ay hindi bababa sa anim na buwan pagkatapos ng unang layunin na pagtugon sa sakit para sa lahat ng mga pasyente. Ang oras ng panggitna na reaksyon ay hindi pa natutukoy.
In the experiment, 18% of patients (n=82 evaluable for safety) had Grade 3 or higher CRS, while 37% of patients had neurologic problems. Anemia, neutropenia, thrombocytopenia, hypotension, hypophosphatemia, encephalopathy, leukopenia, hypoxia, pyrexia, hyponatremia, hypertension, infection-pathogen unclear, pneumonia, hypocalcemia, and lymphopenia were the most prevalent Grade 3 or higher adverse effects (10%). With a Risk Evaluation and Mitigation Strategy, the FDA approved Tecartus (REMS). The Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) REMS Program has been integrated with the Tecartus REMS and is now known as the “Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) REMS Program”
Tungkol kay Tecartus
Tecartus is an autologous, anti-CD19 CAR T cell therapy. Tecartus uses the XLP™ proseso ng pagmamanupaktura na may kasamang pagpapayaman ng T cell, isang kinakailangang hakbang sa ilang mga malignancies na B-cell kung saan ang kumakalat na mga lymphoblast ay isang pangkaraniwang tampok. Bilang karagdagan sa MCL, ang Tecartus ay kasalukuyang nasa Phase 1/2 na pagsubok din sa talamak na lymphoblastic leukemia (LAHAT) at talamak na lymphocytic leukemia (CLL). The use of Tecartus in ALL and CLL is investigational, and its safety and efficacy have not been established in these cancer types.
Indikasyon ng Tecartus
Ang Tecartus ay isang direktang binago ng CD19 na autologous na T cell na immunotherapy na ipinahiwatig para sa paggamot ng mga pasyenteng nasa hustong gulang na may relapsed o repraktibong mantle cell lymphoma (MCL).
Ang pahiwatig na ito ay naaprubahan sa ilalim ng pinabilis na pag-apruba batay sa pangkalahatang rate ng pagtugon at tibay ng tugon. Ang patuloy na pag-apruba para sa indikasyon na ito ay maaaring nakasalalay sa pag-verify at paglalarawan ng klinikal na benepisyo sa isang kumpirmadong pagsubok.
