Biotech Values

[jazzbeerman]

masterlong,

Could you be a litle more specific?
I can't imagine that you're calling radiolabeled mabs themselves bollocks.
So what exactly do you disagree with.

thanks.


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BTW-

I assume you're familiar with Tositumumab's (Bexxar's) clinical data. If not here's a recap from the 2003 ASCO presentation, authored by Andrew D. Zelenetz, MD, PhD, Chief, Lymphoma Service,
Memorial Sloan Kettering Cancer Center.

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/05-31-2003/0001956631&...


Analysis of Long-Term Response Population From BEXXAR Clinical Trials Presented at ASCO

Data Reported With up to Nine Years of Follow-up

CHICAGO, May 31 /PRNewswire-FirstCall/ -- According to data presented
today at the 39th annual meeting of the American Society of Clinical Oncology
(ASCO, Abstract #2316), a high proportion of patients with advanced low-grade
or transformed low-grade non-Hodgkin's lymphoma (NHL) who achieved long-term,
durable responses to BEXXAR(R) (tositumomab and iodine I 131 tositumomab)
therapy had complete responses and many of these patients remain in remission
five or more years after treatment (median 59.1 months, range 47.2-NR).
BEXXAR therapy, being co-developed by Corixa Corporation (Nasdaq: CRXA) and
GlaxoSmithKline (NYSE: GSK), is an investigational radioimmunotherapy in the
final stages of regulatory review by the U.S. Food and Drug Administration
(FDA).
Analyzing data from 250 patients enrolled in five clinical trials of
BEXXAR therapy, investigators determined that 30.4 percent (76 of 250) of
patients had achieved a long-term, durable response, defined as time to
disease progression of one year or more after treatment. These patients were
followed for a median of three and a half years (44.6 months), with a range
extending up to nearly nine years (15.5 months to 107.3 months). Within this
long-term response population, the complete response (CR) rate was 76 percent
(58/76). The median durations of overall response and of complete response
both approached five years; 58.4 months (range 36.5-NR) and 59.1 months (range
47.2-NR), respectively. The median time to progression or death was 60.1
months.
"The ability of BEXXAR therapy to produce remissions lasting five or more
years in patients with advanced, treatment-resistant non-Hodgkin's lymphoma is
very encouraging," said Andrew D. Zelenetz, MD, PhD, Chief, Lymphoma Service,
Memorial Sloan Kettering Cancer Center, and an author of the study. "We've
now been following some durable responders since the early 1990s and can say
with some confidence that patients whose disease does not progress for at
least a year after BEXXAR therapy have a good chance of staying in response
for several more years."
Patients in the long-term response population had a median of three
treatment regimens (range 1-8) prior to receiving BEXXAR therapy and had
multiple poor prognostic characteristics including Stage III/IV disease (88
percent), no response to prior therapy (62 percent), bulky disease >5 cm (49
percent), bone marrow involvement (41 percent), and transformed histology (20
percent). Similar durations of response were observed in patients regardless
of their response to prior therapy, suggesting that the durable responses in
the long-term response population did not simply represent favorable patient
characteristics.




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and here's info on a one-week regimen of Tositumomab as an initial therapy -

http://content.nejm.org/cgi/content/abstract/352/5/441

ABSTRACT

Background Advanced-stage follicular B-cell lymphoma is considered incurable. Anti-CD20 radioimmunotherapy is effective in patients who have had a relapse after chemotherapy or who have refractory follicular lymphoma, but it has not been tested in previously untreated patients.

Methods Seventy-six patients with stage III or IV follicular lymphoma received as initial therapy a single course of treatment with 131I-tositumomab therapy (registered as Tositumomab and Iodine I 131 Tositumomab [the Bexxar therapeutic regimen]). This consisted of a dosimetric dose of tositumomab and 131I-labeled tositumomab followed one week later by a therapeutic dose, delivering 75 cGy of radiation to the total body.

Results Ninety-five percent of the patients had any response, and 75 percent had a complete response. The use of polymerase chain reaction (PCR) to detect rearrangement of the BCL2 gene showed molecular responses in 80 percent of assessable patients who had a clinical complete response. After a median follow-up of 5.1 years, the actuarial 5-year progression-free survival for all patients was 59 percent, with a median progression-free survival of 6.1 years. The annualized rate of relapse progressively decreased over time: 25 percent, 13 percent, and 12 percent during the first, second, and third years, respectively, and 4.4 percent per year after three years. Of 57 patients who had a complete response, 40 remained in remission for 4.3 to 7.7 years. Hematologic toxicity was moderate, with no patient requiring transfusions or hematopoietic growth factors. No cases of myelodysplastic syndrome have been observed.

Conclusions A single one-week course of 131I-tositumomab therapy as initial treatment can induce prolonged clinical and molecular remissions in patients with advanced follicular lymphoma.




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j