Re: Cal-101 for untreated patients?

[Guest guest]

The strategy regarding therapy in cancer tends to be to use

the best tools available at that time. CAL-101's response

rate might only be 30%, but that is because of a

lymphocytosis that classifies patients as having

" progressive disease " even when 90% of their lymph nodes

have reduced in size. One of the most important points that

I have endeavored to emphasize here is the disconnect

between what is best for the patient and what the FDA wants

to see. The 30% response rate might make CAL-101 hard to

approve, but the long-term results and tolerability make the

drug too important to not have.

Rick Furman

>

> It looks increasingly as though CAL-101 only works for a

> certain period of time, and then cancer finds a way to grow

> as if the drug wasn't there.

>

> I personally feel that CAL-101 might be best used with

> Campath. The CAL would shrink the nodes, and the Campath

> would kill the CLL cells. Campath is risky because of

> infection risk, but CAL-101 by itself doesn't do much to

> make a dent in CLL.

>

> There is only a 33% response to CAL-101, and it's best used

> when docs have a better handle on how use it.

>

> Why use up the drug when it will probably not do much? Keep

> it in reserve until good combinations come along. That's my

> opinion.

>

[Guest guest]

, could you cite your sources for this statement? -- Mark

>

> It looks increasingly as though CAL-101 only works for a

> certain period of time, and then cancer finds a way to grow

> as if the drug wasn't there.

[Guest guest]

For Dr. Furman,

There was a note earlier that it now seems CAL-101 stops

working after awhile. I wonder if you have seen that?

I appreciate the repeat of your clarification of why so many

patients are listed with " progressive disease " even it is an

artefact of classification.

Worth remembering, if patients are actually doing well.

Heléne

[Guest guest]

I have only seen one patient where CAL-101 that had

previously been working stop working. We still do not have

a median time to progression on CAL-101 (after 11 months).

Things are early, and only time will tell. But this is a

step forward.

Rick Furman

>

> For Dr. Furman,

>

> There was a note earlier that it now seems CAL-101 stops

> working after awhile. I wonder if you have seen that?

>

> I appreciate the repeat of your clarification of why so many

> patients are listed with " progressive disease " even it is an

> artefact of classification.

>

> Worth remembering, if patients are actually doing well.

>

> Heléne

>

[Guest guest]

There have been comments here that some patients have

progressed after responding to CAL-101. Additionally,

comments I've received from CLL docs I trust have indicated

the same. There are multiple signaling pathways that result

in lymphocyte expansion, and these may become more important

to the CLL clone when the delta isoform of PI3K is blocked.

CAL-101 seems unlikely to be a 'home run' at least as a

single agent, especially as you have mentioned that even the

best results qualify as 'progressive disease'.

______________________________

Posted by: " rrfman "

Wed Mar 30, 2011 4:35 pm

I have only seen one patient where CAL-101 that had

previously been working stop working. We still do not have

a median time to progression on CAL-101 (after 11 months).

Things are early, and only time will tell. But this is a

step forward.

Rick Furman

[Guest guest]

I respect what you have said here ... that more time is

needed to tell, and I expect the same is true for any new

drug, which is the rationale for testing with sufficient

follow up.

Karl

> We still do not have

> a median time to progression on CAL-101 (after 11 months).

> Things are early, and only time will tell. But this is a

> step forward.

>

> Rick Furman

[Guest guest]

The take home message regarding CAL-101 is that patients are

deriving a great deal of benefit and gaining control of

their disease, eventhough they are characterized officially

as having progressive disease. I do not think anything is a

" home run " as nothing is perfect, but the effects of CAL-101

and PCI-32765 are " light-years " ahead of where we were with

chemotherapy.

Rick Furman

[Guest guest]

With all due respect, I don't think CAL-101 is 'light years'

ahead of current therapies. For example, stem cell

transplants can cure CLL. CAL-101 can't.

Yes, this is an exciting area of research. I look for much

more to come in this area.

I think we run the risk of over-hyping CAL-101. Remember,

most people do not respond in the long run to CAL-101.

I have a very difficult case of CLL, and I responded well to

high dose methylprednisolone plus rituximab. My counts were

normal or near-normal for several years.

--

rrfman wrote:

Thu Mar 31, 2011 4:01 pm

The take home message regarding CAL-101 is that patients are

deriving a great deal of benefit and gaining control of

their disease, eventhough they are characterized officially

as having progressive disease. I do not think anything is a

" home run " as nothing is perfect, but the effects of CAL-101

and PCI-32765 are " light-years " ahead of where we were with

chemotherapy.

Rick Furman

[Guest guest]

With all due respect, I don't think we have any idea what

the " long run " is for CAL-101 so where does this " most

people do not respond " generalization come from?

Lynn

>

.... Remember,

> most people do not respond in the long run to CAL-101.

>

>