News

Three-year follow-up data for the phase 2 study of the first-in-class inhibitor of apoptosis protein antagonist, xevinapant, in combination with standard cisplatin-based concomitant fractionation chemoradiation therapy reduced the risk of mortality by half compared with CRT alone in patients with locally advanced squamous cell carcinoma of the head and neck.

A new chimeric antigen receptor (CAR) T cell therapy may help curb the problem of frequent relapse in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

The FDA accepted an investigational new drug application providing clearance to begin an open-label, single-arm phase 1 clinical trial of ATA2271, a next-generation mesothelin targeting CAR T-cell therapy.

Three-year data from a phase 1 study of Voyager Therapeutics’ VY-AADC01 suggest it is safe and offers potential benefits for patients with Parkinson disease.

Combining chimeric antigen receptor (CAR) T-cell therapy and an oncolytic virus were more potent against solid tumors than CAR T-cell therapy alone in mouse models of cancer.

A significant number of patients who undergo chimeric antigen receptor (CAR) T-cell therapy will experience severe neurotoxicity. A new study could help doctors better predict which patients are at risk.

Blinatumomab monotherapy as consolidation therapy prior to allogeneic hematopoietic stem cell transplant resulted a significant improvement in event-free survival and a lower risk of recurrence in children with high-risk B-cell precursor–acute lymphoblastic leukemia.

Candidate continues to demonstrate encouraging safety, tolerability, and efficacy

Pashna N. Munshi, MD, discusses the CAR T-cell therapies that have emerged in the lymphoma space and highlights the next steps for research with these products.

Luciano J. Costa, MD, discusses the emerging role of CAR T-cell therapy in relapsed/refractory multiple myeloma, investigational products such as ide-cel, orva-cel, and JNJ-4528, and early intervention strategies to manage the toxicities associated with these products.

Valoctocogene roxaparvovec would be the first ever approved gene therapy to treat patients with hemophilia A.

The study is designed to evaluate the safety and tolerability, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing solid tumors.

The FDA has placed a clinical hold on the phase 1 P-PSMA-101-001 trial examining the autologous CAR T-cell therapy P-PSMA-101 in patients with metastatic castration-resistant prostate cancer.

Nina Shah MD, discusses the future of CAR T-cell therapy and bispecific antibodies in multiple myeloma.

Evidence-Based Oncology regulatory updates for August 2020 feature coverage of Kite Pharma's new CAR T-cell therapy and selinexor in DLBCL.

Evidence-Based Oncology managed care updates for August 2020 feature coverage of liquid biopsies, companion diagnostics, and CAR T-cell therapy.

A phase 2 study found that data from a 3-year follow up showed statistically significant improvements in overall survival for patients with high-risk locally advanced squamous cell carcinoma of the head and neck treated with an IAP antagonists with chemo-radiation therapy.

Debio 1143 in combination with standard cisplatin-based concomitant fractionation chemoradiation therapy was found to induce a statistically and clinically significant improvement in overall survival compared with CRT alone in patients with high-risk locally advanced squamous cell carcinoma of the head and neck.

Peter Martin, MD, provides an overview of what the current MCL treatment paradigm looks like as well as areas of future exploration and debate.

The FDA this week granted the fourth Orphan Drug Designation for a novel gene therapy product candidate (OCU400, Ocugen Inc.) in the treatment of PDE6B gene mutation-associated retinal diseases.

ABSTRACT Prior to the introduction of trastuzumab, the first targeted anti-HER2 agent, in 1998, patients diagnosed with HER2-positive breast cancer felt like they were being handed a death sentence. Despite treatment with aggressive chemotherapy, their tumors recurred faster, more often spread to brain and liver, and were associated with higher rates of death than HER2-negative tumors. However, in the 1980s, cancer researchers and oncologists recognized that HER2 could be targeted by a small molecule that binds to the receptor on the cell surface and blocks the signal telling the cell to divide. This small molecule was called trastuzumab, and it eventually completely changed how HER2-positive breast cancer was treated. The drug was first approved in the metastatic setting, and then the results of 2 pivotal randomized control trials demonstrated that the administration of trastuzumab in the adjuvant setting decreased the risk of breast cancer recurrence by 50%. These trials showed trastuzumab to be unequivocally effective in the adjuvant setting and the HERA trial results led to the adoption of 1 year of adjuvant trastuzumab as the standard of care. Since that time, the field of anti–HER2-targeted therapy has exploded, with the development of multiple targeted agents for use in the advanced and up-front settings. Although trastuzumab significantly improves outcomes for women diagnosed with HER2-positive breast cancer and has few adverse effects (AEs), the disadvantages are that it requires intravenous administration every 3 weeks and can be associated with cardiac AEs. It is also expensive. Given all of these factors, the question of whether a duration of trastuzumab that is shorter than 1 year may be acceptable for some patients with early-stage HER2-positive breast cancer is an important and very relevant one. Here, we will review the studies that have examined this question and evaluate their results.

Gene therapy to treat choroideremia shows potential for maintaining or improving vision

Sintilimab injection plus pemetrexed and platinum-based therapy led to a statistically significant improvement in progression-free survival compared with chemotherapy alone as a first-line treatment for patients with locally advanced or metastatic nonsquamous non–small cell lung cancer.

A CD30-targeted CAR T-cell therapy was found to elicit a high rate of durable complete responses (CRs) in heavily pretreated patients with relapsed/refractory Hodgkin lymphoma.

Paul J. Shaughnessy, MD, discusses how CAR T-cell therapy is being utilized in hematologic malignancies, challenges faced with this modality, and ongoing research efforts being made to better leverage its use.

Intravitreal injection offers safety, efficacy, and improved vision in patients

Investigators from John Theurer Cancer Center participated in the pivotal ZUMA-2 clinical trial, which assessed the safety and effectiveness of brexucabtagene autoleucel in patients with relapsed or refractory mantle cell lymphoma.

Bristol Myers Squibb and bluebird bio submitted a second Biologics License Application (BLA) to the FDA for idecabtagene vicleucel (ide-cel), the companies’ investigational B-cell maturation antigen–directed chimeric antigen receptor (CAR) T-cell immunotherapy, indicated for adults with relapsed and refractory multiple myeloma (MM).

The FDA granted breakthrough therapy designation to osimertinib for the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent.

The FDA has granted a breakthrough therapy designation to osimertinib for the adjuvant treatment of patients with stage IB, II, and IIIA EGFR-mutated non–small cell lung cancer following complete resection with curative intent.