Johnson & Johnson has an FDA green light to start a new trial of the CAR-T therapy for multiple myeloma it licensed from China’s Legend Biotech for a whopping $350m upfront last December.
Legend’s anti-BCMA CAR-T – called LCAR-B38M and now rebadged as JNJ-68284528 by J&J’s Janssen division – hit the headlines at last year’s American Society of Clinical Oncology (ASCO) meeting after Legend presented stellar data from an early-stage trial that showed a 100% objective response rate in treatment-resistant, relapsed myeloma patients.
The new phase I/II trial, due to get underway in the second half of the year, will also enrol patients with relapsed or refractory multiple myeloma and will start with a phase 1b trial to determine a suitable dose to take forward to the phase II portion, which will gauge efficacy using overall response rate as a primary endpoint.
J&J is going up against some well-positioned competitors in the anti-BCMA CAR-T category, notably Celgene and Bluebird Bio with bb2121, Celgene and Juno with and Kite Pharma/Gilead Sciences’ KITE-585, both of which are on the agenda of this year’s ASCO which gets underway on Friday.
There are other candidates in the pipeline too, including TeneoBio’s TNB-383B, a therapy developed by China’s Pregene Biotech, as well as at least three others in investigator-sponsored trials in China and the US.
In the US alone, there are more than 30,000 new cases of myeloma every year, causing around 12,000 deaths a year and – despite an increasing number of treatment options – the disease remains incurable and CAR-T is viewed as a potentially important new treatment option.
The start of the trial is another signpost on J&J’s road to developing a position in cancer immunotherapy as it tries to catch the leaders in the category such as Bristol-Myers Squibb, Merck & Co and Roche.
Earlier this month it bought oncolytic virus player Benevir Biopharm for $140m upfront and up to $900m in milestones, and also has a collaboration with Aduro for cancer vaccine ADU-214 as well as some in-house projects such as PD-1 checkpoint inhibitor JNJ-63723283, but it is still a minnow among the big fish in immuno-oncology.
Meanwhile, hopes that its anti-CD38 Darzalex (daratumumab) could find a role alongside checkpoint inhibitors in blood cancers and solid tumours took a knock earlier this week after safety issues led to two the termination of two trials of the drug in combination with Roche’s Tecentriq (atezolizumab) and JNJ-63723283.