press release: Epratuzumab Plus Rituximab?

[Guest guest]

Greetings,

Does this news item provide reason for hope, or an opporunity for sponsor

hype? The potential about equal for both, I feel.

The reported response and CR rates are better than what you'd expect in the

relapse setting for Rituxan treatment, but the patient population is small,

not well described, and of mixed histology (Fnhl and SLL). Two histologies

making it hard to intrepret overall Response and CR rates.

The caveats of this study design .. the usual:

single arm study - which are prone to patient selection bias,

no random control (such as versus Rituxan alone),

small and mixed study population.

Notably, it's reported that the particpants with low FLIPI had the higher

response rate to this dual-antibody protocol.

The hope is that without adding signficant toxicity we can improve the

response rate and duration of response of Rituxan. So patients can benefit

clinically and the sponsor financially. This study suggest that hope could

be realized ... But does it demonstrate that non-select patients will

benefit at these rates as described below?... that epratuzumab adds value to

Rituxan? I suspect its purpose was to see if a more objective and expensive

randomized test is called for. Oddly a second slightly larger trial of E+R

in untreated fNHL also lacks a control.

~ Karl

=

Epratuzumab Plus Rituximab Effective in Recurrent NHL

n = 41 patients with follicular NHL and 7 patients with small lymphocytic

lymphoma (SLL),

By Martha Kerr

NEW YORK DEC 11, 2008 (Reuters Health) - Combination therapy with the

anti-CD22 monoclonal antibody epratuzumab and the anti-CD20 monoclonal

antibody rituximab was well tolerated and achieved a durable response in

patients with post-chemotherapy relapsed/refractory*, indolent non-Hodgkin

lymphoma (NHL), results of an international multicenter trial show.

[* Relapsed? I take " chemotherapy relapsed " to mean Rituxan naive]

The study involved 41 patients with follicular NHL and 7 patients with small

lymphocytic lymphoma (SLL), who were given intravenous epratuzumab 360 mg/m²

followed by intravenous rituximab 375 mg/m² once a week for four weeks.

Dr. P. Leonard of Weill Cornell Medical College and New York

Presbyterian Hospital and colleagues report in the November 15 issue of

Cancer that 22 (54%) patients with follicular NHL had an objective response,

10 of whom had complete responses.

Four of the 7 patients with SLL had objective responses, including 3 with

complete responses.

There was an objective response rate of 85% in the 13 patients who had

Follicular Lymphoma International Prognostic Index (FLIPI) risk scores of 0

or 1, whereas 28 patients with higher FLIPI scores had an objective response

rate of 39%.

The median response duration was 13.4 months for the 41 patients with

follicular lymphoma, overall, and 29.1 months for 10 patients who had a

complete response. In patients with SLL, the median response duration was 20

months.

The combination of epratuzumab and rituximab " is very well tolerated (and

is) similar to the profile of rituximab alone, " Dr. Leonard told Reuters

Health. " Using this combination earlier in the course of treatment is of

great interest. "

" There is an ongoing study of the Cancer and Leukemia Group B (CALGB) where

this combination is currently being studied as initial treatment for

follicular lymphoma, " he commented.

[ See CALGB study: http://clinicaltrials.gov/ct2/show/NCT00553501 - also

without randomized control ]

SOURCE:

Cancer 2008;113:2714-2723.