Re: CAL-101 interim results

[Guest guest]

If I read the presentation right, half were discontinued.

This seems like a very discouraging thing!

I know that 30% response in a refractory population is something,

but perhaps those who know more, like Dr. Furman, can speak to why CAL-101 is so

encouraging if half have disease progression, adverse effects or death.

Thanks, Heléne

[Guest guest]

Dear Helene,

I think the enthusiasm is based on its very good activity as a single agent in a

very difficult population with a very good toxicity profile.

Completed (12 cycles)* 3 (3%)

On study 49 (46%)

Discontinued 54 (51%)

Disease progression 33 (31%)

Adverse event 7 (7%)

Death 4(4%)

Other reason 10 (9%)

It seems that most discontinuations were from progression, which is pretty low

and not unexpected for a single agent in this population. And i'm assuming that

deaths were not treatment-related, given the low AE rate.

That only 3% completed the 12 cyles, and we don't have long term follow-up are

reasons we should not rush to judgment about this promising investigational

agent.

All the best,

Karl

> If I read the presentation right, half were discontinued.

> This seems like a very discouraging thing!

>

> I know that 30% response in a refractory population is something,

> but perhaps those who know more, like Dr. Furman, can speak to why CAL-101 is

so encouraging if half have disease progression, adverse effects or death.

>

> Thanks, Heléne

>

[Guest guest]

Dear Helene,

Please note that the presentation referenced is from ASCO last spring. So it is

almost a year old. A more recent presentation (from ASH in December) can be

found on calistogapharma.com.

But your point about 50% discontinuing is still valid. So the main difference is

that there are more CLL patients who have been on CAL-101 for 12 months or more.

I have been taking it for almost 16 months. I am unmutated with del 17p. So

CAL-101 has been great for me. But I may also have to discontinue it due to

progression. My lymphocyte count has gone up on each of my last 3 blood tests

(taken every 8 weeks). It was 8.5 on Aug. 19 and 28.1 on Feb. 3. But my nodes

are stable (by CT scan), and hemoglobin and platelets are also pretty stable. If

the progression continues, I may be able to add rituxin to see if that helps.

So CAL-101 definitely has value. But it will not be a long term solution for

everyone, and possibly not for anyone.

All the best,

Don