Bellicum Pharmaceuticals Announces Rivo-cel™ Achieves Primary Endpoint in Pediatric Registrational Trial
Bellicum Pharmaceuticals, Inc., is considered a pioneer in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders. Indeed, they announced that they achieved the primary endpoint of event free survival at 180 days in its BP-004 European registration trial for rivo-cel (rivogenlecleucel).
In fact, scientific results from this trial will be applied as a framework for an anticipated submission of European Marketing Authorisation Applications (MAAs). The results relate to rivo-cel and rimiducid in support of potential regulatory approval.
Furthermore, these clinical datapoints demonstrate that adding rivo-cel to stem cell transplants in patients, lacking a matched donor, provided comparable results to HLA-matched unrelated donor (MUD) transplants.
Thus, Rivo-cel can become a favorable treatment alternative for the 20-25% of stem cell transplant patients who lack an HLA-matched donor. In addition, rivo-cel can help patients who urgently need a curative transplant and are in danger from waiting several months to find an HLA-matched unrelated donor.
In fact, a 10/10 matched transplant represents a highly compatible match. It is based on a standardized assessment of the histocompatibility of 10 surface protein antigens on white blood cells. Moreover, patients had positive clinical outcomes when given rimiducid.
Finally, Bellicum Management plans to illustrate additional datapoints from the study, including longer term follow-up data, at an appropriate future medical meeting.