Thursday, May 19, 2016
Video courtesy Cancer Research Institute.
Patients with Hodgkin lymphoma whose disease returns after standard treatments have faced a shortage of effective therapies. The FDA has now approved the immunotherapy drug nivolumab for these patients. About two-thirds of patients in a clinical trial responded to the drug, and the benefit appears to be lasting. Nivolumab blocks a molecule called PD-1 and is the first such immunotherapy approved for Hodgkin lymphoma.
- The FDA approved nivolumab for Hodgkin lymphoma.
- The drug is a type of immunotherapy.
- The approval is for patients whose disease resists standard treatments.
- It’s the first PD-1 inhibitor approved for Hodgkin lymphoma.
Hodgkin lymphoma, a type of blood cancer, is usually curable with current therapies. But patients whose disease doesn’t respond to these treatments face difficult odds and — because the disease often strikes people in their twenties and thirties — many of them die at a relatively young age.
Today, their outlook is much brighter. The FDA has approved the immunotherapy drug nivolumab (Opdivo®) for use in Hodgkin lymphoma patients who have exhausted all other treatments. It is only the second drug in the last four decades to be approved for relapsed Hodgkin lymphoma — and the first in a new generation of immunotherapy drugs to be approved for the disease.
The approval is based on results from an international clinical trial led by Memorial Sloan Kettering medical oncologist Anas Younes, which showed about two-thirds of Hodgkin lymphoma patients responded to nivolumab, with minimal side effects. Results from the trial are being published in Lancet Oncology. (The study is currently in press.)
“The FDA approval of this new therapy addresses an urgent medical need for these young men and women,” says Dr. Younes, who is Chief of MSK’s Lymphoma Service. “It greatly enhances our treatment strategies going forward.”
MSK medical oncologist Alexander Lesokhin, who played a critical role in the clinical testing of nivolumab, echoes this optimism. “This is great news for Hodgkin lymphoma patients and for the advancement of immunotherapies in blood cancers,” he says. “This is a wonderful milestone that helps validate our ongoing efforts at MSK to develop the next generation of immunotherapy treatments.”
Nivolumab is a type of immunotherapy drug called a checkpoint inhibitor, which blocks the actions of a molecule called PD-1 on the surface of immune cells. This “releases the brakes” on the immune system, allowing it to mount a stronger attack against cancer. MSK played a critical role in the clinical development of these drugs.
Recent Advances in Hodgkin Lymphoma after Slow Progress
Hodgkin lymphoma is a cancer of the lymphatic system, which originates in white blood cells. Usually patients are successfully treated with chemotherapy alone or a combination of radiation and chemotherapy.
Patients whose Hodgkin lymphoma returns after initial treatment typically receive intensive chemotherapy — which wipes out the cancerous cells — followed by a transplant of their own blood-forming stem cells (called an autologous transplant) to rebuild their immune system.
Despite such demanding therapy, the disease progresses in some people. For these patients, no new treatments existed until 2011, when the FDA approved a drug called brentuximab vedotin, an antibody linked to a toxic chemical similar to chemotherapy.
Although brentuximab vedotin represented an important advance, most patients treated with it eventually saw their lymphoma return, requiring further therapy. The clinical trial led by Dr. Younes tested whether nivolumab would be effective in patients whose Hodgkin lymphoma returned or progressed despite receiving an autologous stem cell transplant followed by brentuximab vedotin.
In the trial, among 95 patients whose cancer returned after this treatment, 65% responded to nivolumab — meaning they had complete or partial remission of their disease. Among this subset of patients, the response lasted a median of 8.7 months.
“After decades with no new treatments, we now have two highly active drugs that may be combinable — that’s why everyone in the field is getting excited,” he says. “It could become the building block for new treatment strategies for patients with this disease.” He added that MSK is developing several new combinations with nivolumab and other similar immune therapy drugs for the treatment of patients with Hodgkin and non-Hodgkin lymphoma.