) recently presented encouraging data from a mid-stage study of its
lead pipeline candidate blinatumomab in adults suffering from
relapsed or refractory B-precursor acute lymphoblastic leukemia (
) at the American Society of Hematology (
Blinatumomub is one of the leading BiTE antibodies that Micromet
is developing. BiTE antibodies represent a new class that activate
the T-cells of a patient's immune system to eliminate cancer cells.
The company is developing blinatumomab on its own.
The data showed that out of the 25 evaluable patients in the
study who had relapsed following standard therapy, 68% (17)
achieved the primary endpoint of complete remission (
) or CR with partial recovery of blood counts (CRh) across all
tested doses. However, for the selected dose, 75% (9 of 12
evaluable patients) achieved CR of CRh. Moreover, there was no
evidence of any remnant leukemic cells in the blood or bone marrow
of all responders. Interim data from the study was earlier
presented in June 2011 and further updated data is expected to be
presented in 2012. We find the data encouraging and believe it
provides further evidence that blinatumomab has the potential to be
used for the treatment of ALL.
Based on positive interim data from the study, Micromet had
initiated a mid-stage trial in the same patient population as above
(with CR/CRh as the endpoint). The mid-stage study will be followed
by a late-stage study (with a time dependent endpoint) to evaluate
the safety and efficacy of blinatumomab versus chemotherapy.
Micromet is also conducting a pivotal study of blinatumomab in
Europe in adults with minimal residual disease (MRD), positive
B-precursor ALL, also referred to as front-line ALL. Data from the
trial is expected to support a marketing authorization for the
indication in Europe.
At the ASH symposium, Micromet also presented data from an
early-stage trial of blinatumomab, in heavily pre-treated patients,
) Rituxan, with diffuse large B cell lymphoma (DLBCL).
The data demonstrated that treatment with blinatumomab produced
durable responses in DLBCL patients. Roughly 55% of the patients
who were treated with blinatumomab achieved an objective response
whereas 38% recorded a complete response. A mid-stage trial is
expected to begin in 2012.
The DLBCL condition is a sub-type of non-Hodgkin's lymphoma
(NHL). Blinatumomub is being evaluated for NHL and has produced a
high response rate and duration of response in a number of
different NHL subtypes like mantle cell lymphoma (MCL).
Currently, we have a Neutral stance on Micromet. The stock
carries a Zacks #3 Rank (short-term Hold recommendation).
We believe blinatumomab holds tremendous potential in the
treatment of ALL. Besides, Micromet's partnerships with large
pharma and biotech companies could generate substantial future
royalty revenues for the company. Micromet has agreements with
pharma giants like
), which are focused on developing BiTE antibodies against
disclosed/undisclosed solid tumor targets.
However, we believe that Micromet requires the strength of a
large established player to accelerate blinatumomab's development
in order to gain a head-start over potential competitors on
approval. We are also concerned about Micromet's early stage
pipeline. Thus, we prefer to remain on the sidelines.
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