Thursday, January 30, 2014

Idelalisib for Indolent/Follicular Lymphoma

Back in September, Gilead applied for FDA approval for Idelalisib for indolent lymphomas (including Follicular Lymphoma) that had stopped responding to Rituxan and to alkylating chemotherapy (including CHOP and Bendamustine). They based the application on phase 2 clinical trial results (which is early).

A couple of weeks ago, the FDA granted Idelalisib "Breakthrough Therapy" designation, meaning it has the potential to be a major advance over anything that is currently available. This ain't no fourth-generation Rituxan wannabe. This is Pulp Fiction at the Cannes Film Festival -- something very new.

The results from that phase 2 trial were published in The New England Journal of Medicine a week ago. That's important, because it means they have been peer-reviewed, with experts in the field looking over the data and the methods for collecting it, and giving their approval.

The Background section of the article is pretty interesting (and more informative than other things I've read about Idelalisib:

Idelalisib  targets something called Pl3K, a lipid kinase that helps to regulate growth and death in cells. Pl3K comes in four different types, and is present in most cells. The fourth type, known as delta, is especially present in  blood cells. Idelalisibwas created to target this particular form of Pl3K, so it is ideal for use with indolent lymphomas. It's a kinase inhibitor, which means it stops Pl3K from doing its evil job of keeping cancer cells alive when they would otherwise die.

The study was fairly small -- 125 patients -- but pretty successful.  I'm not going to get too much into methods and results (you can read on your own, all you people with two healthy shoulders), but basically, 90% of the patients had their lymph nodes shrink. the overall response rate was 57%, including 6% who had a complete response. (Not sure what the difference is between that 90% with shrunken nodes and the smaller number who were classified as "responding.") For what it's worth, the 72 Follicular Lymphoma patients in the study had a 54% response rate, which wasn't the bast, but which was decent. Maybe more important was that "responses were rapid and durable" as patients kept taking the Idelalisib. Side effects were common, though they seem manageable, and doesn't overlap with other treatments, so some combinations might be in the future.

Overall, a bunch of good news in the last month for indolent lymphoma patients. The FDA review will take place later this year; let's hope it's fast and positive, and we have another arrow in the quiver soon.








7 comments:

Anonymous said...

this is great news indeed Bob! hope your shoulder is all better by now, take care
Jeanne

Lymphomaniac said...

Thanks, Jeanne. I'm afraid I'm going to need surgery on the shoulder. Long road ahead, but I'll get through it.

Anonymous said...

you'll breeze through it , keep us posted, btw my husband still remains asymptomatic, however he had pains after a work out on both sides of his upper torso, its a bit swollen im worried but he said it might not be related to FL, will go to the doc to be on the safe side..take care
Jeanne

Lymphomaniac said...

Thanks, Jeanne. I'm glad your husband is going to see the doctor, if only for peace of mind. Especially when I was first diagnosed, I'd call Dr. R a lot when I was concerned, and he was good about getting me in pretty quickly to ease my mind. Now I have a 3 day rule: any bump or pain or anything else unusual, I'll wait 3 days, and if it's still bothering me, I'll call Dr. R.

I hope your mind is eased after the doctor visit.

Anonymous said...

Hi there! thank you for the advice, the 3 day rule, doctor said the swollen part is actually a lymph node but is less than 2 cm, so nothing to worry, but she suggested to move his scheduled April CT scan a month earlier which will be in March, im starting to have scanxiety as early as now( its me, never him), but today he said the swollen part has gone down a bit, might be wax and wane i suppose? and was aggravated by muscle injury due to his weight lifting, doctor at MD anderson told us that he could do any work out he wants as long as nothing too exhausting like triathlon, hope he doesnt use this as an excuse not to exercise :O
Jeanne

Lymphomaniac said...

The node might be swollen from the injury -- behaving like a normal node is supposed to, rather than as a cancer response? Whatever the case, you'll know more in March. Try to stay calm -- look to him as your model.

Anonymous said...

thank you Bob! how is your shoulder? when is the surgery?

jeanne