BioPharma, Pharma

J&J to enter Chinese CAR-T for myeloma into Phase Ib/II trial

The clinical trial of the CAR-T - a potential competitor to bluebird bio's - will start enrolling patients later this year.

T-cells attacking cancer cell illustration of microscopic photosT-cells attacking cancer cell illustration of microscopic photos

A Chinese CAR-T therapy that drew significant attention at last year’s American Society of Clinical Oncology meeting will enter a clinical trial in the US later this year.

Johnson & Johnson subsidiary Janssen said Wednesday that it had started a Phase Ib/II clinical trial of the CAR-T, which carries the development name JNJ-68284528 in patients with relapsed or refractory multiple myeloma. The trial – which does not yet appear on the ClinicalTrials.gov registry – is planned to open for enrollment in the second half of this year.

The CAR-T was originally developed by Nanjing, China-based Legend, under the development name LCAR-B38M. Janssen announced in December that it had paid Legend $350 million upfront for a worldwide licensing agreement for the therapy. The China Food and Drug Administration has already accepted the CAR-T for review, according to Janssen’s Dec. 21, 2017 press release.

Presented at last year’s ASCO meeting, the CAR-T produced a 94 percent remission rate among 35 patients. Among 19 patients who had been followed for more than four months, 14 had shown a complete disappearance of their tumors – known as a stringent complete response, or sCR – while four experienced a remission of most of their disease, known as a very good partial response, or VGPR.

The CAR-T targets a cell-surface protein called BCMA, similar to a more well-known CAR-T for multiple myeloma, bb2121, made by Cambridge, Massachusetts-based bluebird bio, which has a partnership with Celgene. The company plans to present data at this year’s ASCO meeting showing that among 18 patients in the Phase I study evaluable for efficacy, 94 percent responded to treatment. The rates of patients whose disease did not progress at six and nine months were 81 percent and 71 percent, respectively. In addition to the Phase I study, bb2121 is in a Phase II study, data from which bluebird will use to seek approval for the therapy.

Currently, the only two CAR-T therapies with US Food and Drug Administration approval are Novartis’ Kymriah, for acute lymphoblastic leukemia in children, and Gilead Sciences’ Yescarta, for diffuse large B-cell lymphoma, which Gilead acquired as part of its $11.9 billion buyout of Kite Pharma last August. Apart from its partnership with bluebird, Celgene spent about $9 billion in January to acquire Seattle-based Juno Therapeutics, which is developing a CAR-T called JCAR017, or lisocabtagene maraleucel, for diffuse large B-cell lymphoma.

Numerous Chinese firms and medical centers have also been developing CAR-T therapies targeting various diseases: A search for “chimeric antigen receptor” studies in China on ClinicalTrials.gov reveals more than 100 entries. Meanwhile, in January 2017, Kite Pharma announced a deal with Shanghai-based Fosun Pharmaceutical to develop Yescarta in China. Manufacturing commenced in December.

Photo: royaltystockphoto, Getty Images

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