The Lynx Group

Hematologic Malignancies

In the phase 3 DETERMINATION trial—in which patients with newly diagnosed multiple myeloma were randomly assigned to a standard triplet regimen with and without autologous stem-cell transplantation (ASCT), with all receiving lenalidomide (Revlimid) maintenance therapy until disease progression—patients with ASCT had significantly longer progression-free survival (PFS) versus those who did not, but no difference in overall survival (OS) was observed between the 2 treatment arms.
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More than 50% of adults with refractory or relapsed large B-cell lymphoma (LBCL) who were not deemed candidates for high-dose chemotherapy and hematopoietic stem-cell transplantation (HSCT) had complete responses (CRs) following treatment with the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi).
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The novel BCL-2 inhibitor, lisaftoclax (APG-2575), elicited encouraging responses and acceptable tolerability in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and other hematologic malignancies, according to results of a phase 1 study presented at the American Society of Clinical Oncology 2021 virtual annual meeting.
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According to the American Cancer Society, nearly 35,000 new cases of multiple myeloma will be diagnosed in the United States in 2021, and approximately 12,410 deaths will be attributed to the disease.1 However, with the introduction of several novel therapies, the outcomes for patients with newly diagnosed multiple myeloma have improved significantly over the past decade.
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The addition of the PI3K inhibitor copanlisib (Aliopa) to rituximab (Rituxan) reduced the risk for disease progression or death by 48% compared with placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (NHL) in the phase 3 CHRONOS-3 clinical trial. The results of this study were presented at the 2021 virtual American Association for Cancer Research (AACR) annual meeting and published simultaneously in Lancet Oncology.
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Orlando, FL—The investigational B-cell maturation antigen (BCMA)-­directed chimeric antigen receptor (CAR) T-cell therapy known as JNJ-4528 induced responses in 100% of 29 evaluable patients with heavily pretreated relapsed or refractory multiple myeloma, according to the results of the phase 1b/2 CARTITUDE-1 clinical trial reported at ASH 2019.
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Orlando, FL—The investigational dual-targeted CD38 chimeric antigen receptor (CAR) T-cell therapy achieved an objective response in more than 90% of patients with relapsed or refractory multiple myeloma who had received ≥3 previous therapies and whose disease had spread outside of the bone marrow. Furthermore, the therapy cleared extramedullary lesions in almost all patients with these lesions, according to results presented at ASH 2019.
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On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). The FDA granted this application priority review.
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On June 27, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with lenalidomide (Revlimid; Celgene) and dexamethasone for the first-line treatment of patients with multiple myeloma who are ineligible for autologous stem-cell transplantation (ASCT). This approval was granted a priority review and used the Oncology Center of Excellence Real-Time Oncology Review program. This is the sixth indication for daratumumab in multiple myeloma and the second indication for newly diagnosed patients.
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On July 3, 2019, the FDA granted accelerated approval to selinexor (Xpovio; Karyopharm Therapeutics), a nuclear export inhibitor, in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received ≥4 previous therapies and did not respond to other forms of treatment, including ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-­CD38 monoclonal antibody. The FDA reviewed selinexor using its fast track program, and granted it an orphan drug designation.
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