The Targeted Pulse: T-Dxd Received FDA Breakthrough Therapy Designation, Real-World Data Confirms Brexu-cel’s Impact, and More

Advanced Breast Cancer Treatment Gets Boost with T-DXd’s New FDA Status

Fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) has received breakthrough therapy designation from the FDA for the treatment of unresectable or metastatic hormone receptor-positive (HR+)/HER2-low or HER2-ultralow breast cancer. The designation is based on data from the phase 3 DESTINY-Breast06 study (NCT04494425), which compared T-DXd with investigator’s choice of chemotherapy. The breakthrough therapy designation aims to expedite the development and regulatory assessment of treatments for serious medical conditions with significant unmet needs. T-DXd has been granted this designation 8 times, with 4 of those designations specifically for metastatic breast cancer.

“If approved, [T-DXd] could once again change the treatment paradigm for certain patients with breast cancer, pushing past old boundaries and broadening the number of people who may be eligible for a HER2-directed therapy,” said Ken Takeshita , MD, global head of research and development at Daiichi Sankyo , in a press release.

Real-World Data Confirms Tecartus Efficacy in Relapsed/Refractory ALL

Brexucabtagene autoleucel (Tecartus; brexu-cel) is confirmed as an effective treatment for patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (ALL), according to real-world data from the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry. In this article, Evandro Bezerra, MD, discusses the data, providing an in-depth perspective with background from the phase 1/2 ZUMA-3 trial (NCT02614066)—which served as the basis for the FDA approval of brexu-cel—and what these data mean for the community. Bezerra is from the Ohio State University Comprehensive Cancer Center-James Cancer Hospital & Solove Research Institute , Columbus, Ohio.

“One of the main takeaways is that in the ZUMA clinical trial, patients had a minimal requirement of 5% blasts in the bone marrow to be eligible for the treatment. In the real-world setting, a lot of these patients are receiving brexu-cel with less than 5% bone marrow blasts. Despite this, brexu-cel still remains effective. Even the patients who are responding to salvage therapy or bridging therapy, they still respond to brexu-cel, and the patients should be considered to receive brexu-cel, despite having lower disease [burden],” Bezerra said.

ON-SITE Study: Innovative AI Module Aims to Improve Lung Cancer Diagnosis

A new study, using an artificial intelligence (AI)-based image analysis module to detect lung cancer, has enrolled its first patient. The study, named ON-SITE, combines stimulated Raman histology with AI to more accurately and quickly diagnose lung cancer than traditional methods during bronchoscopy. The NIO Laser Imaging System provides rapid imaging of fresh tissue biopsies directly in the treatment room, eliminating the need for staining or sectioning. This streamlined design allows the operating room staff to efficiently prepare and analyze samples without additional processing steps.

“[Rapid-on-site tissue evaluation (ROSE)] requires that a cytologist or highly trained cytotechnician be physically present in the procedure room, and thus it is not available at many centers performing lung biopsy due to resource limitations,” Jason Akulian, MD, said in a press release. “We are excited by the NIO's potential to extend the benefits of ROSE to the proceduralist when the service is not available.” Akulian is director of interventional pulmonology at the University of North Carolina at Chapel Hill School of Medicine .

Myeloma’s Kryptonite? Weighing Treatment Weaknesses and Strengths in MM

In this article, Amrita Krishnan, MD, director of the Judy and Bernard Briskin Center for Multiple Myeloma Research at City of Hope and executive medical director of hematology at City of Hope Irvine, discussed the impact T-cell engagers including chimeric antigen receptor (CAR) T-cell therapy and bispecific antibodies targeting multiple antigens in multiple myeloma (MM). Krishnan also addressed ongoing challenges in treating MM, particularly concerning precision medicine and the sequencing of therapies.

“[The central nervous system (CNS)] in myeloma remains an extremely challenging area when patients relapse with either leptomeningeal disease or CNS disease,” Krishnan explained. “One of the biggest unmet needs right now are for patients with plasma cell leukemia, and they remain a challenging group of patients to treat. These are patients who have aggressive, rapidly proliferative disease, and because CAR T cells, for example, take a while to manufacture, those patients may progress before you can even give them CAR T cells. Better bridging strategies for patients before CAR T cells is another unmet need.”

Tafasitamab Plus SOC Scores in Follicular Lymphoma Phase 3 Trial

Tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) and rituximab (Rituxan) improved progression-free survival (PFS) for patients with relapsed or refractory follicular lymphoma (FL). In the global, double-blind, randomized, controlled, pivotal Phase 3 inMIND trial (NCT04680052), investigators compared this combination to lenalidomide and rituximab alone and found no new safety signals associated with tafasitamab.

“While many patients with follicular lymphoma initially benefit from first-line treatment, relapse of the disease is common, underscoring the need for additional therapies,” said Steven Stein MD , chief medical officer, Incyte , in a press release. “These results demonstrate the potential of tafasitamab added to the standard of care to be a meaningful new treatment option for patients with FL whose disease has progressed after at least 1 prior therapy.”

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