Zacks_Analysts' Blog : Micromet's Blinatumomub Data at ASH - Analyst Blog

Micromet Inc. (MITI) 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 (ALL) at the American Society of Hematology (ASH) meeting.

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 (CR) 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, particularly with Roche (RHHBY)/Biogen’s (BIIB) 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).

Our Recommendation

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 Bayer (BAYRY), AstraZeneca (AZN), Sanofi-Aventis (SNY), and Amgen, Inc. (AMGN), 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.