Chinese “Legend” Talking about the Starry CAR-T Products on ASCO with Global CAR-T Giants

The ASCO (American Society of Clinical Oncology) Annual Meeting—an annual event on oncology, was successfully concluded in the beautiful McCormick Place, Chicago on June 6, 2017. This globally influential oncology meeting published the latest progress of many oncology clinical studies and was quite substantial, such as, the latest progress of many oncology clinical trials, including the IDOi/PD-1 antibody combination, Loxo Oncology’s broad-spectrum oncology drug R&D pipeline, clinical progress of CAR-T products, and PD-1 antibody combination, etc., which are worthy of attention and in-depth exploration of the industry participants. This article focuses on the latest clinical data of CAR-T products, in particular, the latest clinical data of Nanjing Legend Biotech, CAR-T giants Kite Pharma, Novartis, Juno, etc.

I. Chinese voice on CAR-T: firstly, the Chinese "Legend"

We can find by reviewing the development of the tumor immunotherapy that it has brought novel control means overs tumors, however, the development of CAR-T Cell Therapy has been tortuous. The T Cell Therapy, based on the cell engineering and process progress, greatly improves the efficacy of refractory cancer patients, and a series of new target antigen 1 and CAR design is under development, such as CD22, BCMA, EGFRvIII, carbonic anhydrase IX, carcinoembryonic antigen and IL13Rα-2, and some have started to be tested in blood and solid tumor.

China Nanjing Legend Biotech gained considerable fame in this ASCO Annual Meeting. It announced the clinical progress of the anti-BCMA CAR-T cell product LCAR-B38M for multiple myeloma. The data of the early phase clinical trial are stunning: the indication is relapsed or drug resistance multiple myeloma, 33 cases/35 cases of patient showed clinical response, the overall response rate (ORR) was 100%, 14 cases/35 cases had complete response (CR), and 5 cases/35 cases had partial response (PR). Regarding safety, 85% patients experienced CRS, and there were no central nervous system side effects.

II. World CAR-T giants: Novartis and Kite Pharma expecting to have the first CAR-T product

CAR-T Cell Therapy is one of the highlights in this annual meeting, and its positive clinical data make the industry regain confidence, wherein, the main competitors in the field: Juno, Kite Pharma, Novartis and Bluebird Bio all have published clinical data of core products, and Novartis and Kite Pharma are still leading, summed up as follows:

1. Positive early phase clinical trial data of new CAR-T product JCAR017 of Juno

As the pioneer of CAR-T Cell Therapy, Juno possesses rich product pipelines (as shown in the above figure) and development experience. Its old JCAR015 product has been stopped all clinical development due to multiple serious clinical death events. Juno announced new CAR-T product in this annual meeting: this product JCAR017 is different from the fallen "ROCKET" JCAR015 in several aspects: the CD4:CD8 T cell ratio of the new product is fixed, and the costimulatory molecule is 4-1BB, with the main data: regarding safety, 66% patients did not experience any cytokine storm or neurotoxicity; the ORR was 86%, and the CR was 59%. (See the following table for the details)

2. Multiple myeloma treatment: Bluebird Bio/Celgene product showing outstanding performance

Bluebird Bio formally joined the cell therapy competition with Five Prime in 2015. The bb2121 co-developed by Bluebird Bio/Celgene showed excellent early phase clinical trial data. Targeting BCMA and multiple myeloma patients with stem cell transplantation, the product showed 100% response rate. (See the following table for the detailed data)

3. Kite Pharma VS Novartis: Novartis steadily leading by 2 months

The core CAR-T products of two companies have obtained priority review and breakthrough therapy designation, with Novartis’ tisagenlecleucel-T leading and expected to become the first CAR-T Cell Therapy approved. Before this, Kite had one patient death event, which triggered argument about the CD28 costimulatory domain applied in the CAR-T Therapy of Kite Company and 4-1BB costimulatory domain used by Novartis. Risk control is still the issue to be most concerned about in cell therapy. Relevant clinical trial data are summarized in the following table:

The above latest clinical progress in this annual meeting will make people marvel at the rapid development of cell immunotherapy and the rapid optimization of the cell engineering process. Juno Company has undoubted advantages in the field, and its process improvement on JCAR017 product is of great reference value.

By Tang