Ofatumumab (anti-cd20) in untreated FL

August 30, 2010

Within is a link to new study posted to the ClinicalTrials.gov registry.

A few comments:

The expectation seems to be that Ofatumumab (a next generation anti-cd20

antibody) could be as effective and safe as Rituxan in FL, and possibly more

effective but probably not dramatically so.

This is a 100-patient single arm study, and the primary endpoint is response

rate; the secondary measure of efficacy is how long it lasts (PFS) - which

we may assume will be compared with historical results for single agent

Rituxan in this population.

QUESTIONS:

Is this a pilot study (to see if a second trial is worth doing)? And if so,

shouldn't the study population be smaller?

Or is this a study to determine equivalence or superiority (or a

non-inferiority study)? And if so, shouldn't it be instead be a randomized

test against Rituxan?

Anyhow, a basic consideration for would-be participants is what are the

competing protocols?

.. Rituxanx4 with option to use extended Rituxan if response to Rx4.

.. Rituxan with Lenalidomide in a clinical trial

.. Bendamustine + Rituxan . and so on.

This use of Ofatumumab could one day prove to be effective, but I have two

concern: that the clinical rationale is modest - just not compelling enough

to attract participation; and that the study design is unlikely to provide

meaningful information if completed.

=

Ofatumumab in Treating Patients With Previously Untreated Stage II, III, or

IV Follicular Non-Hodgkin Lymphoma

Indication: Lymphoma/CLL, b-cell expressing CD20

(HuMax-CD20T) is a fully human, high-affinity antibody targeted at the CD20

molecule in the cell membrane of B-cells.

(FDA has provided conditional approval for refractory CLL)

== Others studies for Ofatumumab for lymphoma / CLL http://bit.ly/91zoO5

All the best,

~ Karl

Patients Against Lymphoma

Patients Helping Patients

Non-profit | Independent | Evidence-based

Recommended Posts