The CAR-T treatment known as Liso-cel (Lisocabtagene Maraleucel) was approved by the European Commission last week for some patients with aggressive Follicular Lymphoma types. Liso-cel is also known as Breyanzi. This is the second version of CAR-T to get approval.
As a reminder: CAR-T (or Chimeric Antigen Receptor T-cell therapy) is the general name for a bunch of different treatments that work in the same way. In this treatment, a patient's T cells are removed (T cells are a kind of immune cell) and then changed in a laboratory so that they recognize cancer cells the same way they would recognize a virus or bacteria. Then they are put back into the patient, and they search for the cancer cells. It has been a very successful treatment for lots of blood cancer patients (though not all), and it's one of the treatments that oncologists get very excited about. However, it's also very expensive (it can cost almost US$500,000), and some patients can have severe side effects.
The EC approval is for aggressive lymphomas, including Grade 3b Follicular Lymphoma grade 3B (FL3B), who relapsed within 12 months of receiving immuno-chemotherapy, or who are refractory to it (it didn't work when they tried it).
The approval comes from the results of a phase 3 clinical trial called TRANSFORM. The patients in the study were put into two groups. the first received "standard of care" (that is, what they would have received if they weren't in a trial) -- immuno-chemotherapy, and a stem cell transplant if that didn't work. The other group received chemotherapy and then the CAR-T.
The results were what we have come to expect at this point, with the CAR-T group having a 73.9% Complete Response, versus 43.5% for the chemo group. The chemo group's median Progression Free Survival was 6.2 months, while the CAR-T group's median was not yet reached after 17.5 months (in other words, more than half of the group was still responding after almost a year and a half).
And side effects were manageable for the CAR-T group, with Cytokine Release Syndrome and nerve-related side effects both common, but taken care of quickly (as CAR-T becomes more common, doctors are much more aware of these side effects and take care of them before they become too problematic).
While this affects a small subset of patients with FL, it's another step toward having this CAR-T approved for other patients with Follicular Lymphoma. (In fact, the day before this news was announced, the makers of Breyanzi announced positive results for a phase 2 trial involving Relapsed/Refractory FL patients.)
It's all very good news, and just more evidence that CAR-T is likely to be a part of many more FL patients' futures.
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