This year, approximately 11,000 patients combined will be diagnosed with Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (ALCL). Compared to other cancers, such as breast and lung, these two lymphomas are considered relatively rare cancers. So, chances are, you didn't hear the news about brentuximab vedotin (SGN-35), which is now called Adcetris.
HL and ALCL are potentially highly curable types of lymphoma when conventional chemotherapy regimens and radiation therapy are used. For this reason, no new drugs have been approved by the U.S. Food and Drug Administration for Hodgkin lymphoma since 1977.
But if you are one of the unlucky ones who aren't cured with these conventional regimens, today is a good day for you. Indeed, it's a good day for all of us. A good day for humanity.
A new drug has been approved
Today, the Oncologic Drugs Advisory Committee/ODAC, an FDA advisory panel, voted 10-0 to recommend accelerated approval for Adcetris to treat patients with relapsed Hodgkin lymphoma after having a stem cell transplant, and for patients with relapsed or resistant systemic ALCL.
The ADC binds to CD30, which is mainly expressed on lymphoma cells, and enters the cells to deliver the toxic drug. By doing so, the toxic drug is specifically delivered to the tumor cells with little toxic effect to normal cells.
The Hodgkin lymphoma study
In the HL study, 102 patients (median age 31) who had previously failed an autologous stem cell transplant were treated with the single agent Adcetris (given by 30-minute intravenous infusion every three weeks, for up to 16 doses). Patients had a median of four previous chemotherapy regimens and some had as many as 13 previous regimens.
The overall objective response rate (complete and partial remissions) was very impressive at 75%, with approximately one-third of patients having complete remission. Many patients who achieved complete remission continued to be free of disease for a long time.
The Anaplastic Large Cell Lymphoma study
The ALCL trial involved 58 patients (age 18-64) who were treated in the same way as HL patients. Of the participants, 86% achieved either partial or complete remission, with 57% experiencing complete remission. The average duration of the complete remission was more than one year (13.2 months).
This is a good beginning. Adcetris is being combined with front-line regimens that are used to treat patients with HL (ABVD) and ALCL (CHOP) to improve the cure rate. Other combinations in the relapsed settings also are planned.
This is a perfect example of why patients with cancer should participate in clinical trials, even though they involved drugs in Phase I early development. When we started the Phase I of SGN-35 (before it was named brentuximab vedotin and now Adcetris), it was 2007.
For many patients, a drug that was identified by letters and numbers (SGN-35) was their only hope. For those who participated in the original first-in-man Phase I study -- some of whom are alive and well -- they know very well that they weren't guinea pigs. They made a big difference for themselves,and for many others to come.
This may look like one small step for man in the overall war on cancer. But, without a doubt, it's a giant leap for Hodgkin lymphoma and anaplastic large cell lymphoma patients.
It's a good day for all of us in the trenches fighting cancer.