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  • Kirk Hartley

Antibody Drug Conjugates – New Science Seems to be Hitting the Zone – 23 out of 26

23. It’s a number made special by Michael Jordan. But now 23 also has special meaning for persons facing T-cell lymphoma. The number relates to a phase 1 study of an anti-body drug conjugate. ADCs, as they are called, combine a drug with a "targeting" agent to get the drug into the desired cells. In this new study, the ADC went 23 for 26 in creating complete remissions in persons receiving the drug to treat their t-cell lymphomas. Talk about being in the zone – those numbers are stunning. And, the other 3 persons received partial remissions. The press release is pasted below.

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"Seattle Genetics Reports Data From Phase I Trial Of ADCETRIS® (Brentuximab Vedotin) In Front-Line Mature T-Cell Lymphomas (MTCL)

-100 Percent Objective Response Rate, Including 88 Percent Complete Remissions, in Newly Diagnosed MTCL Patients Treated with ADCETRIS in Combination with CHP Chemotherapy-

-Data Support Planned Phase III Trial in Front-line MTCL, Including Systemic Anaplastic Large Cell Lymphoma and Other Types of Peripheral T-cell Lymphomas-

ATLANTA–(BUSINESS WIRE)–Dec. 9, 2012– Seattle Genetics, Inc. (Nasdaq: SGEN) today announced results from a phase I clinical trial of ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed mature T-cell lymphoma (MTCL) patients, including patients with systemic anaplastic large cell lymphoma (sALCL). The data were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is not currently approved for use in the front-line treatment of MTCL.

In the phase I trial, newly diagnosed patients received six cycles of ADCETRIS every three weeks in combination with cyclophosphamide, doxorubicin and prednisone (CHP). This regimen removes vincristine (Oncovin) from CHOP, the standard treatment in this setting. Patients who achieved at least a partial remission after completing six cycles of combination therapy were eligible to receive continued single-agent ADCETRIS for up to ten additional 3-week cycles. The primary endpoints of the trial included defining maximum tolerated dose of ADCETRIS in combination with CHP and evaluating safety. The secondary endpoints were investigator assessment of response, progression-free survival and overall survival.

After completing combination therapy, 26 of 26 patients (100 percent) treated with ADCETRIS plus CHP had an objective response, including 23 patients (88 percent) with a complete remission. All 23 patients who achieved a complete remission demonstrated normalized glucose uptake by PET (positron emission tomography) evaluation.

“The standard front-line regimen for patients with mature T-cell lymphomas is a combination chemotherapy regimen, CHOP, that has demonstrated complete remission rates of 39 to 53 percent, with a 5-year overall survival rate of less than 50 percent,” said Michelle Fanale, M.D., Associate Professor in the Department of Lymphoma/Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “There is significant need to advance the treatment paradigm for newly diagnosed patients with these aggressive types of lymphoma. Data from this trial support further evaluation of ADCETRIS in the front-line treatment of patients with mature T-cell lymphomas.”

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About Kirk

Since becoming a lawyer in 1983, Kirk’s over 30 years of practice have focused on advising a wide range of corporations, associations, and individuals (as both plaintiffs and defendants) on both tort and commercial law issues centered around “mass torts.”

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