Seattle Genetics-Takeda’s Adcetris Shows Long-Term Effect – Analyst Blog

Seattle Genetics, Inc. ( SGEN ) and Takeda Pharmaceutical Company Limited ( TKPYY ) announced four-year overall survival data from a pivotal phase II study evaluating the efficacy and safety of Adcetris for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Adcetris showed durable, long-term responses in this treatment setting.

At a median follow-up in the study at 46.3 months, the four-year survival rate was estimated to be 64% (median overall survival (OS) of 55.1 months) with progression-free survival (PFS) of 20 months. In other words, more than 60% of patients suffering from relapsed or refractory ALCL treated with Adcetris were alive at the fourth year of follow-up. One-third of all the patients treated in this study showed complete remission with no evidence of disease after a median follow-up of 46 months.

The company stated that historical outcomes for patients suffering from relapsed T-cell lymphoma, including systemic ALCL have shown a median OS of 5.5 months with a median PFS of 3.1 months.

Meanwhile, Seattle Genetics also announced detailed results from a randomized, double-blind, placebo-controlled phase III study (AETHERA) on Adcetris for the treatment of Hodgkin lymphoma patients with the risk of disease progression following autologous stem cell transplantation (ASCT). PFS was higher in Adcetris-treated patients compared to placebo (43 months versus 24 months).

Earlier, in Sep 2014, the company had already announced that the study met its primary endpoint with a 75% improvement in PFS. Seattle Genetics intends to submit a supplemental biologics license application to the FDA for Adcetris for the above-mentioned indication in the first half of 2015.

Adcetris is already approved in more than 45 countries for the treatment of Hodgkin lymphoma after failure of ASCT or after failure of at least two prior multi-agent chemotherapy regimens in non-ASCT patients and the treatment of sALCL after failure of at least one prior multi-agent chemotherapy regimen.

Additionally, Seattle Genetics reported data from two ongoing phase I studies on SGN-CD19A for the treatment of B-cell malignancies including non-Hodgkin lymphoma and acute lymphoblastic leukemia. SGN-CD19A showed multiple objective responses without significant myelosuppression or neuropathy. Based on this data, the company plans to initiate a randomized phase II study on SGN-CD19A for this indication in 2015.

The above data was presented at the annual meeting of the American Society of Hematology (ASH).

Seattle Genetics holds a Zacks Rank #2 (Buy). Some better-ranked stocks in the biotech sector are Biogen Idec Inc. ( BIIB ) and Amgen Inc. ( AMGN ). Both carry a Zacks Rank #1 (Strong Buy).

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Seattle Genetics-Takeda's Adcetris Shows Long-Term Effect - Analyst Blog