This week: Responses to Yescarta deepen over time and new collaboration will commercialize automated cell therapy manufacturing platform.
The news highlights:
ASCO 2018: Novel immunotherapy elicits complete response in breast cancer patient
ASCO 2018: Complete response rates to CAR-T therapies deepen over time
Automated platform for cell therapy manufacturing is one step closer to commercialization
A breast cancer patient who was unresponsive to other treatments has had a complete response to a novel approach to immunotherapy developed at the National Cancer Institute (NCI; MD, USA). In the trial, led by Steven A. Rosenberg, chief of the Surgery Branch at NCI’s Center for Cancer Research (CCR), the patient received a modified form of adoptive cell transfer (ACT) that uses tumor-infiltrating lymphocytes (TILs) to specifically target four of 62 tumor cell mutations identified through DNA and RNA sequencing of the patient tumor. She was also given the checkpoint inhibitor pembrolizumab to prevent the possible inactivation of the infused T cells by factors in the tumor microenvironment. After the treatment, all of this patient’s cancer disappeared and has not returned more than 22 months later.
“This is an illustrative case report that highlights, once again, the power of immunotherapy,” said Tom Misteli, director of CCR at NCI. “If confirmed in a larger study, it promises to further extend the reach of this T-cell therapy to a broader spectrum of cancers.”
Long-term follow up of the ZUMA-1 trial, in which patients were treated with axicabtagene ciloleucel, or Yescarta (Kite Pharma, Gilead; both CA, USA), an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, has demonstrated that patients with initial partial responses developed complete responses up to a year after treatment. 108 patients with refractory B-cell lymphoma were followed for a median of 15.4 months following their dose of 2 x 106 CAR-T cells/kg.
“We did an analysis of the ZUMA-1 trial to figure out what to do with patients at 3 months. If we have a patient in remission at 3 months – whether it be a partial or a complete response – can we wait it out?,” Frederick Lundry Locke, program co-leader of immunology at Moffitt Cancer Center (FL, USA), told HemOnc Today.
“One-third of patients in complete response initially attained a partial response, and that response deepened over time. Over half of patients who progressed did so by the 3-month time point, leading to the need to define treatment practices at this time. We believe month 3 is clinically relevant to understand patient outcomes.”
Read more news from American Society of Clinical Oncology (ASCO) 2018 on our sister site, Oncology Central
Hitachi Chemical Advanced Therapeutics Solutions (formerly PCT Cell Therapy; NJ, USA) and Invetech (Victoria, Australia) have agreed to collaborate on the commercialization of the Counter-Flow Centrifugation system (CFC). The CFC is fully automated and designed for research, preclinical, clinical and commercial manufacturing of cell-based therapies using closed single-use disposables through the automation of common processes in the cell therapy manufacturing process such as transduction, washing, and concentration. It was awarded a 2017 Good Design Award®.
“We are excited to announce this collaboration with Invetech, as the CFC will serve as a cornerstone of our superior delivery platform for the cell therapy industry” said Robert A. Preti, President and CEO of HCATS and General Manager, Hitachi Chemical Regenerative Medicine Business Sector.
“This agreement strengthens HCATS’ capabilities in contracted cell manufacturing, and pursuit of end-to-end solutions for cell therapy clients. It continues HCATS’ drive to provide the industry with high-quality, cost-efficient manufacturing platforms and solutions to advance the commercialization of cellular therapies. We look forward to introducing our clients to the advantages of the CFC and continuing to listen and respond to their product commercialization needs.”
For more weekly cell therapy news, read previous editions of the cell therapy weekly.