Tazemetostat: The Official Numbers

Last June, the FDA approved Tazemetostat for Follicular Lymphoma patients with the EZH2 mutation who had already had treatment, and for FL patients who were essentially out of other options.

The approval was based on the results of a phase 2 clinical trial involving patients in 38 clinics or hospitals in France, the UK, Australia, Canada, Poland, Italy, Ukraine, Germany, and the United States. 

This week, the results of that phase 2 trial were published in The Lancet Oncology journal. This is important, because the data has now been peer-reviewed -- other experts in the field have looked at the data and have given it their approval. The study was designed and conducted well, and the results are valid. 

The article, "Tazemetostat for Patients with Relapsed or Refractory Follicular Lymphoma: An Open-Label, Single-Arm, Multicentre, Phase 2 Trial," presents data that is similar to what was reported when Tazemetostat was approved: 69% of patients with the EZH2 mutation had a response to Tazemetostat, and it lasted a little under 11 months.

EZH2 is an enzyme that controls the EZH2 gene, which controls whether a cell should die like it is supposed to. When EZH2 mutates, the cell doesn't know it is supposed to die which, of course, leads to cancer. Tazemetostat is an EZH2 inhibitor, which means it inhibits or stops mutated EZH2 from keeping cancer cells alive.

Roughly 25% of FL patients have the EZH2 mutation, so Tazemetostat might not be in everyone's future. But for those who do have the mutation, it seems like it should give them some hope. It works on FL in ways that no other treatment does, currently. 

It will be interesting, too, to see how Tazemetostat works in combination. As you probably know, there are lots of treatments for FL and other cancers that do a decent job on their own, but then do a much better job when combined with other treatments that work on cancer cells in a different way (like Rituxan, which works well on its own but also makes some chemo even better). I look forward to seeing results from some of those trials soon.

I also look forward to seeing results from the phase 3 trial that will look at how Tazemetostat works on a larger group. 

Lots to be hopeful about.