Findings from the pivotal phase II ZUMA-2 trial of KTE-X19 as a treatment for adult patients with relapsed/refractory mantle cell lymphoma were published in the New England Journal of Medicine, as the FDA considers a biologics license application for the CAR T-cell therapy for an approval in this setting.
The FDA cleared the investigational new drug (IND) application for the use of CYNK-001 in adults with COVID-19.
Mantle cell lymphoma is a type of B-cell non-Hodgkin lymphoma with a typically poor prognosis. Even with an allogeneic stem cell transplant, patients can become resistant to chemotherapy. Most do not survive 4 or 5 years after diagnosis, and the 10-year survival rate hovers between 5% and 10%.
Carlos R. Bachier, MD, discusses the use of CAR T-cell therapy in the outpatient setting. He also shared insight on the evolving paradigm of graft-versus-host disease.
Tania Jain, MBBS, discusses blood count recovery in patients with hematology malignancies who receive CAR T-cell therapy.
Sameer Desai, MD, discusses his experience in the hematology field and how CAR T-cell therapy has evolved and its potential integration into community centers.
Preliminary data from the ASPIRO study of Audentes Therapeutics resamirigene bilparvovec gene therapy suggests it is safe with improvements in neuromuscular and respiratory function.
Craig Sauter, MD, discusses results of a retrospective, real-world review of patients with hematologic malignancies who developed cytopenia post-CAR T-cell therapy.
Nearly all patients in this cohort achieved a clinically meaningful >3-point increase during the study period, demonstrating a consistent response to the gene therapy.
Gregory A. Otterson, MD, discusses the utility of immunotherapy in squamous non–small cell lung cancer and targeted the evolution of targeted therapy in biomarker-driven disease.
Himisha Beltran, MD, discusses research evaluating cell-free DNA to identify therapy resistance in prostate cancer.
David P. Carbone, MD, PhD, discusses advances in immunotherapy and targeted therapy in non–small cell lung cancer and ongoing research efforts focused on acquired resistance to available therapies.
The Chinese National Medical Products Administration has approved almonertinib (Ameile; HS-10296) for the treatment of patients with EGFR T790M mutation–positive non–small cell lung cancer who have progressed on or after other EGFR TKI therapy.
Che-Kai Tsao, MD, discusses the current unmet needs in adjuvant therapy for patients with renal cell carcinoma and how current research is addressing such challenges.
In adolescent patients with sickle cell disease, hydroxycarbamide therapy was associated with improvements in neurocognition variables such as working memory, verbal memory, and nonverbal IQ, according to study findings.
While the cell and gene therapies approved so far are indicated for rare diseases with small patient populations, the successes of chimeric antigen receptor-T (CAR-T) therapies and expanding interest from biopharma stress the need to rapidly scale the supply chain as these therapies move toward commercial availability for more disease states and larger patient populations.
Janssen Pharmaceutical Companies recently announced the FDA granted breakthrough therapy designation to JNJ-61186372, an EGFR-MET bispecific antibody, for the treatment of metastatic non-small cell lung cancer with EGFR exon 20 mutations.
The FDA has placed a partial clinical hold on a phase I trial assessing the autologous T-cell therapy ACTR707 in combination with rituximab for patients with CD20-positive, B-cell non-Hodgkin lymphoma due to a safety concern.
The FDA has granted a breakthrough therapy designation to JNJ-61186372 for the treatment of patients with EGFR-positive metastatic non–small cell lung cancer who harbor exon 20 insertion mutations, and whose disease has progressed on or after platinum-based chemotherapy.
The triplet therapy of ixazomib, lenalidomide, and dexamethasone showed an improvement in progression-free survival, but it was not statistically significant, compared with lenalidomide/dexamethasone alone for patients with newly diagnosed multiple myeloma who were ineligible for stem cell transplant.
Mohammad Maher Abdul-Hay, MD, discusses current standards for the treatment of patients with acute lymphocytic leukemia.
Investigators have turned their attention to B-cell maturation antigen, which offers an ideal target for multiple myeloma therapy because of its restricted expression pattern.
City of Hope scientists have developed and tested the first CAR T-cell therapy using chlorotoxin, a component of scorpion venom, to direct T cells to target brain tumor cells.
Dylan Essner discussed the implementation of documentation tools and CRS, ICANS and ICE flow sheets within CAR T-cell therapy.
During a discussion at The American Journal of Managed Care®’s Patient- Centered Oncology Care® meeting in Philadelphia, panelists outlined the efficacy of the 2 FDA-approved therapies, Medicare reimbursement for CAR T-cell therapies, and the pace of innovation in healthcare.
Noopur Raje, MD, discusses the investigational CAR T-cell therapies and strategies in the multiple myeloma pipeline.
The associate director for clinical research at the Washington University School of Medicine spoke about the value and challenges of using EMRs in CAR T-cell therapy.
With the main toxicities associated with CAR T-cell therapy being cytokine release syndrome and neurotoxicity, a multidisciplinary approach is vital to providing inclusive care to patients receiving this type of treatment.
Jae H. Park, MD, discusses the challenges in using CAR T-cell therapy in adult patients with acute lymphoblastic leukemia, and also highlights the potential role for off-the-shelf CAR T cells.
The FDA has granted a breakthrough therapy designation to Debio 1143, an inhibitor of apoptosis protein antagonist, for the treatment of patients with previously untreated, unresectable, locally advanced squamous cell carcinoma of the head and neck in combination with standard cisplatin-based concomitant fractionation chemoradiation therapy
