News

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.

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

Michael Choi, MD, sheds light on the data with BTK and BCL-2 inhibitors in CLL and shares ongoing research being done with PI3K inhibitors and CAR T-cell therapy in the relapsed/refractory setting.

Health-related quality of life (QOL) improved in 54% of patients 18 years or older with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) after therapy with tisagenlecleucel (Kymriah; Novartis), one of 2 FDA-approved chimeric antigen receptor (CAR) T-cell therapies. The patients’ general health, vitality, physical function, and social function improved the most.

Dimitrios Tzachanis, MD, PhD, discusses updates and remaining questions with CAR T-cell therapy.

The novel B-cell therapy has been assigned a PDUFA date of June 2020.

An “off-the-shelf” Epstein Barr-virus–specific cytotoxic lymphocyte CAR product derived from cells harvested from third-party donors induced a 100% response rate in adult and pediatric patients with relapsed/refractory non-Hodgkin lymphoma.

Outpatient administration of CAR T-Cell therapy is safe and effective, according to an analysis of 3 studies of lisocabtagene maraleucel in patients with relapsed/refractory large B-cell lymphoma.

Diego Villa, MD, MPH, discusses the benefit of bendamustine and rituximab versus R-CHOP in transplant-eligible and -ineligible patients with mantle cell lymphoma.

Several clinical trials have found mesenchymal stem cell therapy effective in treating neural damage in patients with multiple sclerosis (MS), according to a review published in Stem Cell Investigation.

The FDA has granted a priority review designation to a new drug application for lurbinectedin as a treatment for patients with small cell lung cancer who have progressed following platinum-containing therapy.

The expert explained the rationale for the phase I first-in-human clinical trial evaluating the combination of a gamma-secretase inhibitor and B-cell maturation antigen CAR T-cells in patients with heavily pretreated multiple myeloma.

The associate professor of clinical medicine discussed the main side effects of CAR T-cell therapies when treating multiple myeloma, and how to combat them.

A high body mass index at baseline may be independently associated with improved survival outcomes in patients with non–small cell lung cancer who receive immune checkpoint inhibitor therapy.

Treatment with a CD19-targeted CAR-natural killer–cell therapy led to a 73% objective response rate, including 7 complete responses, in patients with relapsed/refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia.

The FDA has granted a priority review designation to a biologics license application for the anti-CD19 CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma after at least 2 prior therapies.