Seattle Genetics-Takeda Reveal Impressive Adcetris Data

Pipeline updates are highly awaited events in the pharmaceutical/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

Earlier this week, Seattle Genetics, Inc. SGEN and partner Takeda Pharmaceutical Company Ltd. announced positive top-line data from the randomized phase III AETHERA study on Adcetris as a consolidation therapy immediately following an autologous stem cell transplantation [ASCT] in patients suffering from Hodgkin lymphoma.

The AETHERA study compared the use of Adcetris as a single agent to placebo in 329 Hodgkin lymphoma patients who were at risk of relapse. Results showed that patients treated with Adcetris lived significantly longer without the disease worsening compared to those in the placebo arm.

Adcetris met the primary endpoint of improvement in progression-free survival [PFS] compared to placebo by achieving 75% improvement in PFS. Seattle Genetics also said that most of the placebo-treated patients were administered Adcetris after their disease showed progression.

Seattle Genetics intends to make an analysis of overall survival in this study in 2016. The company will present detailed data from the study in the annual meeting of the American Society of Hematology [ASH] in Dec 2014. It intends to submit a supplemental biologics license application (BLA) to the FDA for Adcetris in the above mentioned indication in 2015.

According to the American Cancer Society, nearly 9,200 patients in the U.S. will be diagnosed with Hodgkin lymphoma in 2014 with more than 1,200 expected to die from the disease. More than 62,000 cases of Hodgkin lymphoma are diagnosed each year in the world. Up to 30% of these patients relapse or are refractory to frontline treatment with only few patients having therapeutic options beyond ASCT.

We note that apart from the AETHERA study, Adcetris is being evaluated in three other phase III studies − ALCANZA (relapsed cutaneous T-cell lymphoma (CTCL)); ECHELON-1 (front-line advanced classical Hodgkin lymphoma) and ECHELON-2 (front-line CD30-positive MTCL, including systemic anaplastic large cell lymphoma (sALCL)).

Adcetris is already approved in more than 45 countries for the treatment of relapsed Hodgkin lymphoma and sALCL.

Other stocks worth considering in the health care sector are Gilead Sciences Inc. GILD and Medivation, Inc. MDVN.

Disclosure: None.

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