News

The FDA has granted a breakthrough therapy designation to MK-6482 for the treatment of patients with von Hippel-Lindau disease–associated renal cell carcinoma who have nonmetastatic tumors of less than 3 centimeters, unless immediate surgery is necessitated.

The FDA granted breakthrough therapy designation to MK-6482 for the treatment of patients with von Hippel-Lindau disease-associated renal cell carcinoma and orphan drug designation to MK-6482 for von Hippel-Lindau disease.

No serious adverse events reported through 24 weeks of a 52 week trial.

The introduction of tyrosine kinase inhibitor therapy earlier in the treatment timeline for patients with EGFR-mutant non–small cell lung cancer holds the promise of improving overall survival for this patient population.

The European Medicines Agency has granted access to the PRIME initiative for the Specific Peptide Enhanced Affinity Receptor T-cell therapy ADP-A2M4 for the treatment of patients with synovial sarcoma.

Assessing the value of novel therapies has been challenging and controversial using existing methods, pointing to the need for continued exploration of new approaches.

New phase 1/2 data shows AAV-RGPR may benefit a previously untreated population of inherited retina disease boys and young men.

The therapy, to be sold as Tecartus, will be used to treat adult patients with mantle cell lymphoma who have relapsed or not responded to other treatments.

The agent is now the first and only approved CAR T-cell therapy to treat adult patients with relapsed or refractory mantle cell lymphoma.

The FDA has approved the CAR T-cell therapy brexucabtagene autoleucel (Tecartus; formerly KTE-X19) as a treatment for adult patients with relapsed/refractory mantle cell lymphoma.

Umbilical cord blood provides a readily available source of stem cells to provide better access to hematopoietic stem cell transplantation to safely and effectively treat various noncancerous genetic disorders in children.

During ASCO, Janssen presented results from the CHRYSALIS study on amivantimab, a bispecific antibody being developed to treat non–small cell lung cancer (NSCLC). The pharma giant, along with its parent company, Johnson & Johnson (J&J), had previously received a breakthrough therapy designation in December for teclistamab, another bispecific antibody indicated for potential treatment of multiple myeloma.

The FDA has cleared an investigational new drug application for the first-of-its-kind, off-the-shelf CAR T-cell product FT819, which targets CD19-positive malignancies.

The National Comprehensive Cancer Network published a document intended for patients to understand how CAR-T cells work and what side effects are associated with the treatment.

The European Medicines Agency has validated a Marketing Authorization Application for the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and grade 3B follicular lymphoma following at least 2 prior therapies.

Advances of chimeric antigen receptor T-cell therapy technologies are in rapid development and under investigation in a range of preclinical and clinical research around the globe.

ABSTRACT Historically, platinum-based chemotherapy was the standard of care for metastatic lung cancer. However, since the success of immune checkpoint inhibitors (ICIs) in melanoma, PD-1/PD-L1 and CTLA-4 immune checkpoint pathways have been established as effective therapies to manage advanced non–small cell lung cancer (NSCLC) and extensive-stage (ES) small cell lung cancer (SCLC). Multiple large-scale randomized clinical trials have analyzed the effects of ICIs in NSCLC, and results of these trials have since translated to the approval of single-agent PD-1/PD-L1 inhibitors, and the combination of PD-1 inhibitors with platinum-based chemotherapy has become the new standard of care for patients with advanced NSCLC. Furthermore, in ES SCLC, in which chemotherapy or chemoradiation has been the standard of care for decades, 2 anti–PD-1/PD-L1 agents have been approved for use in the frontline setting for ES SCLC, in combination with chemotherapy. Despite progressive integration of immunotherapy into treatment regimens, there remains a need for reliable biomarkers to precisely determine therapy candidates.

Pralsetinib, an investigational precision therapy in late-stage development for individuals with alterations in the RET gene, would be jointly sold in the United States by the 2 companies if it is approved.

The FDA has issued a clinical hold on the phase 1 MELANI-01 trial evaluating the CAR T-cell product UCARTCS1A in the treatment of patient with relapsed/refractory multiple myeloma.

Lifleucel, a TIL therapy, is being investigated in patients with metastatic melanoma.

The patient guide explains 2 possible side effects, cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, that need to be caught quickly in order to be reversible.

Patients with chemotherapy-naïve, locally advanced, or metastatic non-small cell lung cancer who were treated with tiragolumab plus an anti-PD-L1 agent showed better efficacy versus single-agent checkpoint inhibitor therapy alone.

Immunotherapy and chimeric antigen receptor (CAR) T-cell therapy are new and important treatments revolutionizing care of some cancers; however, their side effects can be very different than what is seen in traditional approaches, such as chemotherapy.

There are promising signs that chimeric antigen receptor (CAR) T-cell therapies might lead to meaningful advances in the therapy of multiple myeloma. However, investigators will first need to clear a number of key hurdles.

Natalie Sophia Grover, MD, discusses ongoing research with CAR T-cell therapy in hematologic malignancies, efforts examining the potential for this approach in solid tumors, and future directions and challenges with this modality.

Patients with B-cell non-Hodgkin lymphomas and B-cell acute lymphoblastic leukemia can benefit greatly from chimeric antigen receptor (CAR) T-cell therapy, but providing that therapy has become much more difficult in the age of coronavirus disease 2019 (COVID-19).

Findings from an exploratory analysis of the phase 1/2 ZUMA-1 trial demonstrated clinical efficacy in patients with relapsed/refractory large B-cell lymphoma who were retreated with the CAR T-cell therapy axicabtagene ciloleucel.

Jesus G. Berdeja, MD, further discusses other exciting trials in multiple myeloma and CAR T therapy being presented at the 2020 ASCO Virtual Scientific Program.

The FDA granted accelerated approval to selinexor (Xpovio, Karyopharm Therapeutics) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The oral treatment is to be used after at least 2 lines of systemic therapy.

The FDA approved oral selinexor for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after at least 2 lines of systemic therapy.