China researchers claim 90% complete remission rates in CAR-T trial

A research team in China has announced exciting results in an early-stage trial of CAR-T cancer therapy, helping it keep pace with other pioneers in the field.

The trial in 10 patients suffering from relapsed or refractory B lymphoblastic leukaemia produced a complete remission in nine of the patients – and could represent a cure for these individuals.

Jointly conducted by First Affiliated Hospital of Zhejiang University and China’s Innovative Cellular Therapeutics (ICT) company, the results add to the excitement around CAR-T therapies, in which the body’s own immune system is trained to attack cancers.

Professor Huang He from the First Affiliated Hospital of Zhejiang University presented the results at a congress in China on Friday, reporting that all 10 patients were expected to live only a few more months, but now 9 out of 10 have achieved complete remission.

The results from China are another confirmation that CAR-T cell therapy can offer a cure for some of the most acute lymphomas and leukaemias, and has the potential to transform treatment in solids tumours as well.

All ten patients, ranging in age from 17 to 57, suffered from relapsed or refractory B lymphocytic leukaemia and were expected to live only several months. The tenth and final patient is a 17-year-old female who enrolled in the CAR-T clinical trial in March of this year, and was one of the patients who acheived complete remission.

Another promising indication was the minimal residual disease (MRD) marker.  This turned negative in eight patients, a significant indication of curative effect. The researchers say both the complete remission rate of 90% and the MRD-negative rate of 80% out-performed the best results recorded worldwide to date.

ICT is already expanding trials of the treatment in relapsed and refractory acute lymphocytic leukaemia, with seven other hospitals across China having already completed the trial and initial data collection of 23 patients suffering from an advanced stage of the disease. Twenty patients, or 87% of the total trial population, enjoyed complete remission of leukaemia.

As ICT points out, only a handful of firms – Novartis, Juno and Kite Pharma – have developed similar levels of CAR-T therapy for acute blood cancers. All three of these firms have FDA Breakthrough Therapy Designation for their lead CAR-T candidates:

Novartis’s CTL019 in relapsed/refractory acute lymphoblastic leukaemia; Kite’s KTE-C19 in non-Hodgkin lymphoma, and Juno’s JCAR015 for relapsed or refractory B-cell acute lymphoblastic leukaemia.

Another firm, Cellectis has also produced exciting results. In November it released preliminary results from a single one-year-old patient, who had also achieved complete remission from her acute lymphoblastic leukaemia (ALL).

ICT says its breakthrough means it has now joined this “distinguished group’ to become one of the global leaders in the application of CAR-T therapy.”

Based on the success of its leukaemia trial, ICT says it will now set its sights on a new clinical trial for the treatment of lymphoma. Looking ahead, ICT will focus R&D efforts on solid tumours including colorectal cancer, breast cancer, gastric cancer and oesophageal cancer.

Novartis is currently tipped to be first to file its candidate, but all the companies still have much to prove to regulators in terms of safety, efficacy and manufacturing standards before they can gain approval.

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