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CAR T-Cells Shown Effective in Long-Term Studies

Cancer in headline

(PDPics/Pixabay)

11 December 2017. Results from two clinical studies of engineered immune system cells show patients continue to respond their treatments after 6 months or more. Findings of tests of therapies by Novartis and Gilead Sciences are presented at the annual meeting of the American Society of Hematology, or ASH, now underway in Atlanta, Georgia.

Drug makers Novartis and Gilead Sciences are reporting on clinical trials of genetically engineered T-cells, white blood  cells from the patient’s immune system, modified to express chimeric antigen receptor proteins. The therapies reprogram the T-cells with genetic engineering to find and kill cancer cells like an antibody. These modified chimeric antigen receptor or CAR T-cells are infused back into the patient, seeking out and binding to a protein called CD19 found on the surface of B cells — another type of white blood cell — associated with several types of blood-related cancers.

Researchers from MD Anderson Cancer Center in Houston, offer results from an early and intermediate-stage clinical trial of axicabtagene ciloleucel, code-named KTE-C19, originally developed by Kite Pharma, but acquired by Gilead Sciences when it bought-out Kite in August 2017. This study is enrolling 142 individuals with aggressive and stubborn cases of non-Hodgkin lymphoma at 29 sites in the U.S., Israel, Canada, and the Netherlands.

MD Anderson oncologist Sattva Neelapu reports on 108 patients at 22 sites after a median period of 15 months following their treatments with KTE-C19. More than a year after their treatments, 42 percent remain in remission and 40 percent show no evidence of cancer. Neelapu says in an ASH statement, “Patients who are in remission at 6 months tend to stay in remission,” adding “With existing therapy, the median survival for people with this disease is only 6 months. Here, we see more than half of patients — 59 percent — are still alive over a year after treatment.”

As reported in Science & Enterprise, CAR T-cell treatments can cause serious adverse effects, leading to deaths in some clinical trials, including this study. Neelapu says 4 patients died within 2 months of treatment, while another 10 patients experienced serious adverse effects, such as infections, in the first 6 months. After 6 months, however, no deaths or new cases of cytokine release syndrome, the most common adverse effect, were reported.

A team from University of Pennsylvania medical school reports on a clinical trial of the Novartis drug tisagenlecleucel, marketed as Kymriah, approved by the Food and Drug Administration in August 2017 as a treatment for children and young adults with B-cell acute lymphoblastic leukemia. The intermediate-stage clinical trial is recruiting 130 participants with diffuse large B-cell lymphoma — the most common form of lymphoma — at 28 sites in the U.S., Canada, Japan, and Europe, where the disease is relapsing or not responding to other therapies.

Stephen Schuster, a professor of hematology and oncology at UPenn, offers interim results from 46 participants, where 30 percent achieved a complete response or remission to treatments, where all signs of the disease disappear, and another 7 percent showed a partial response. Among a larger group of 81 participants whose cancer disappeared after 3 months, the disease in these individuals did not relapse after another 3 months.

Most of the adverse effects are seen soon after the therapies, mainly cytokine release syndrome and neurological toxicity. No deaths are reported from these treatments. Schuster says about a quarter (26%) of the treatments are given in an outpatient setting, and in some cases, the patients T-cells are frozen until ready to administer. “These are very sick patients,” notes Schuster, “so this gives the treating physician some flexibility to schedule therapy when it’s best for each patient.”

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Hat tip: FirstWord Pharma

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