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been criticized for “selective patient disclosures by treatment site.” At ASH, for instance, Nanjing reported data from 57 patients at a trial site in Xian, China. Additionally, noted Porges, Nanjing appears to have selected patients who aren’t as sick as those in Celgene’s studies—they failed a median of three treatments. Taken together, “the data…appear very good, although attempting to compare this data to the CAR-T trials by Celgene is a flawed exercise,” wrote Porges.
Nonetheless, this is a short summary what Nanjing Legend and J&J reported:
LCAR-B38M: After a median follow-up of 12 months, 50 of 57 (88 percent) of patients had responded to treatment, of which 42 (74 percent) showed no signs of cancer. The treatment has lasted a median of 16 months. Four patients (7 percent) had a severe CRS case.
Amgen is coming at multiple myeloma from a different angle. It’s using an antibody called AMG 420 that latches on to two different targets: BCMA and a second that is on T cells. The goal is to provide a simpler alternative to CAR-T. Amgen isn’t alone with this approach—others, like GlaxoSmithKline, are involved too—but it is the first to produce human data. Perhaps Amgen “may be clever enough to differentiate from the pack with an ‘off-the-shelf’ anti-BCMA product,” Porges wrote, which might be suitable for older patients in the community setting who can’t get access to, or aren’t eligible for, CAR-T. It might have to: the results “fall short” of the recent hype that’s surrounded the program, Porges wrote.
Even so, should AMG 420 succeed in clinical testing and get to market, Amgen will have its own logistical hurdles to overcome. One dose cycle of AMG 420 requires a continuous IV infusion for four weeks straight, then two weeks off, and patients need to keep getting the drug via a permanent catheter or port delivery system to see its effects. That “may have contributed to the rates of serious infection [12 patients (29 percent)]” that Amgen has seen in the study, Porges wrote.
AMG 420: Amgen tested multiple doses. 13 of 42 patients (31 percent) who had failed a median of four treatments responded to AMG420, though Amgen highlighted that 7 of 10 (70 percent) responded to the dose it intends to take into further testing.
Poseida, a privately held company based in San Diego, CA, is pursuing an aggressive development timeline for its CAR-T product, a treatment called P-BCMA-101, for which it owns full rights. Poseida aims to begin a pivotal study next year and file for approval by the end of 2020, which would put it right in the thick of the race with Bluebird/Celgene, Nanjing/J&J and others. At ASH, Poseida disclosed the most detailed data to date on P-BCMA 101. Here’s a snapshot:
P-BCMA-101: 15 of 19 evaluable patients who failed at least six treatments responded to its experimental P-BCMA-101, and five of them had no trace of cancer. It’s unclear how long those responses have lasted. Poseida noted that four of four responded to the mid-range dose it will take into Phase 2 studies. Poseida hasn’t seen any serious cases of CRS in the study yet.