Physicians like Robert Chen, M.D., once had no options to offer the nearly one-third of their patients with Hodgkin’s lymphoma who did not respond to conventional treatments. That changed with the recent federal approval of an investigational drug called brentuximab vedotin.
|Robert Chen, left, discusses a clinical study that led to approval of a new drug to treat lymphoma as patient Susan Romo listens. (Photo by p.cunningham)|
On Aug. 19, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the drug, now called Adcetris, for two specific groups of lymphoma patients.
One group includes Hodgkin’s lymphoma patients who fail to respond to at least two prior multiagent chemotherapy regimens or to autologous stem cell transplantation, in which they receive their own purified blood stem cells.
The other group consists of those with anaplastic large cell lymphoma who do not respond to a multiagent chemotherapy regimen.
The approval for Hodgkin’s lymphoma follows a pivotal phase II clinical trial held at 26 centers worldwide from 2008 to 2010. The study involved 102 patients, 11 of whom received treatment at City of Hope under Chen, assistant professor of hematology and hematopoietic cell transplantation and 2010 Tim Nesvig Lymphoma Research Fellow at City of Hope.
“This is very exciting because there has been no drug approved for Hodgkin’s lymphoma in more than 30 years,” Chen said.
Response rates were very high, he said. “Seventy-five percent of patients achieved objective response, which means that the tumors shrank by 50 percent or more.” In addition, 34 percent of patients achieved complete remission, and about 96 percent of patients had at least some tumor shrinkage.
Patients with Hodgkin’s lymphoma, a cancer of the lymphatic system, carry Hodgkin Reed-Sternberg cells, abnormal cells that express a protein called CD30. Adcetris consists of an engineered antibody linked to a chemotherapy drug. The antibody portion binds to CD30 and the chemotherapy drug prompts the malignant cells to destroy themselves.
“The concept of this drug is novel, using the antibody to target chemotherapy to the lymphoma cells only,” said Chen. “It makes it very potent with mild side effects.”
Through other clinical trials involving Adcetris, City of Hope has treated about 50 patients with the drug.
“The drug allowed them to have relief from symptoms and also survive longer,” Chen said.
A message of hope
Susan Romo was 36, newly married with a 9-year-old son and had just earned her paralegal degree when symptoms began in 2007.
“I had night sweats, weight loss, constant coughing, and horrible itching — everywhere, constantly,” recalls the Bellflower, Calif., resident. In July of that year, she was diagnosed with Hodgkin’s lymphoma stage 2b and began six months of chemotherapy.
It did not work.
She came to City of Hope and underwent intensive chemotherapy for three months, followed by two autologous stem cell transplants. A subsequent PET scan revealed the tumors were still there.
“At that point, Dr. Chen spoke to me about the trial drug and told me I was a perfect candidate,” Romo said.
From May 2009 to April 2010, she received infusions of Adcetris every three weeks as an outpatient. She experienced some nerve-related side effects — tingling in her hands and feet that sometimes made it difficult for her to type or walk up stairs — but these symptoms gradually lessened.
“After awhile, I started to realize that maybe this is the thing that’s going to work for me,” she said.
Her illness greatly deepened her faith as well as her empathy for others who are struggling with illness. “I want to encourage people who are going through what I’ve been through,” she said.
Echoing a message she remembers from Chen and her medical team, she added, “It’s hard, but you can get through it.”
As she resumes her busy family life, she is allowing herself to make plans again: finding a job, running a marathon, perhaps even becoming a foster parent.
Said Romo: “I want to live fearlessly, not just as a survivor, but a conqueror.”