Immunotherapy Drug Approved for Treatment of Hodgkin Lymphoma

By Jim Stallard,

The immunotherapy drug nivolumab is giving hope to Hodgkin lymphoma patients like Ariella after standard treatments don’t work. Video courtesy Cancer Research Institute.

Summary

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.

Highlights
  • 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.

Two out of three patients with relapsed Hodgkin lymphoma responded to nivolumab, with minimal side effects.

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.”

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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.

Nivolumab has already been proven effective against solid tumors such as melanoma, lung cancer, and kidney cancer. This FDA approval is the first for a PD-1 inhibitor to treat blood cancer.

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.

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Choosing MSK may give you access to new treatment options before they’re widely available elsewhere.
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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.

After decades with no new treatments, we now have two highly active drugs that may be combinable.
Anas Younes
Anas Younes Chief, Lymphoma Service

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.

Dr. Younes added that ongoing trials are testing whether giving patients who have failed other treatments a combination of nivolumab and brentuximab vedotin will be even more effective.

“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.

Comments

What about Falicular B cell lymphoma?

Joseph, thank you for reaching out. There are a number of clinical trials under way that focus on immunotherapy or immune mediated approaches that would include follicular lymphoma. If you would like to learn whether these trials might be apprpropriate for you, we suggest you contact Memorial Sloan Kettering's Physician Referral Service

at 800-525-2225 or go to https://www.mskcc.org/experience/become-patient/appointment

You also could contact Devin Callan at 212-639-6104 for details as well.

Immunotherapy is still reserved for AFTER secondary chemo and transplant therapy, correct?

It's not an option for directly after first line therapy (ABVD Chemo/Radiation) failure?

Thank you for reaching out. Yes, immunotherapy is currently used after secondary chemo and transplant therapy. Clinical studies will evaluate the safety/efficacy of nivolumab in earlier settings.

Our daughter was diagnosed with Hodgkins in April of this year, she has been undergoing the standard ABVD treatment. Unfortunately it is not working. They have offered her to either undergo ICE or to try the clinical trial of the Nivolumab and Brentuximab. In reading your comments you suggest this after the second line of chemo has failed and not the first. Is it possible to try it after the first line chemo has failed? Are there some specific questions we should be asking the her oncologist?

Kim, we're sorry to hear about your daughter. We are not able to make individual recommendations on our blog. If you'd like to arrange for a consultation with one of our experts, you can call 800-525-2225 or go to https://www.mskcc.org/experience/become-patient/appointment for more information on making an appointment. Thank you for your comment.

Can you please share any research/ current treatment preferences on the front line treatment for NLPHL?

Hi Raju, we recommend that you reach out to the National Cancer Institute's Cancer Information Service at 800-4CANCER to learn more about this condition. If you're interested in making an appointment for a consultation at MSK, you can call 800-525-2225 or go to https://www.mskcc.org/experience/become-patient/appointment for more information on making an appointment. Thank you for your comment.

Dr Portlock treated my son for Hodgkins along with Dr Yahalom. My son was an MD/PHD student at the time at Albert Einstein College of Medicine. That was in 1997. My son is in perfect health now thank G-d. He's a board certified general surgeon and a Yale U. Fellowship trained breast cancer surgeon. I am very grateful to Drs Portlock and Yahalom for essentially saving my son's life. Thank you

Dear Racheline, we're so glad to hear your son is doing well. We will pass your message along to Dr. Portlock and Dr. Yahalom. Thank you very much for your comment, and best wishes to you and your family.

I had recurrent hodgkins (after ABVD) with second line chemo (& full mantle radiation) and then an autologous stem cell transplant in year 1999/2000. I Have been lean & clear since for which i am most thankful!!

If someone like me is clear for this long period, would I be still be eligible for nivolumab and brentuximab based protocol straightaway or would I be considered as a "new" Hodgkins Lymphoma patient and redo original protocols firdt. I do understand that I did have my lifetime limit of a couple of the A & D chemos. Thanks

Dear Rick, unfortunately we are not able to answer individual medical questions on our blog. We recommend you discuss this with your cancer care team. If you're interested in arranging a consultation at MSK, you can call 800-525-2225 or go to https://www.mskcc.org/experience/become-patient/appointment for more information on making an appointment. Thank you for your comment, and best wishes to you.

Hi There
I was treated in the MSK last year for primary refractory disease by Dr Craig Moskowitz and I was given ICE therapy with radiation which put me on remission. I was hospitalized for 4 months after that for stem cell transplant and bowel obstruction. Although I am doing somewhat OK now I been hospitalized for 6 times since I got discharged at the end of 2016. I always afraid of my lymphoma to come back but 7 months after stem cell transplant I am cancer free still??? I am always afraid now days when it is coming back????

Dear Shaheed, we're sorry to hear you're feeling worried about cancer recurrence. In addition to your regular follow-up visits with Dr. Moskowitz, you may want to reach out to someone at our Counseling Center to learn more about strategies for coping with your feelings. You can call 646-888-0100 to make an appointment or go to https://www.mskcc.org/locations/directory/msk-counseling for more information.

You may also find it helpful to participate in Connections, our online support group for cancer patients and survivors, as well as their families. You can learn more at https://www.mskcc.org/experience/patient-support/counseling/groups/conn…

Thank you for your comment, and best wishes to you.

I was diagnosed in 2012 with non-hodgkins lymphoma and have been treated with rituxan
and radiation. Would I be a candidate for
immunotherapy? I an 77 rears young. Thank You.

Dear Gloria, we're sorry to hear about your diagnosis. It's possible that you may benefit from immunotherapy. If you would like to have a consultation with a doctor at MSK to find out about treatment options, you can call 800-525-2225 or go to https://www.mskcc.org/experience/become-patient/appointment for more information on making an appointment. Thank you for your comment.

I know there are currently clinical trials regarding Nivolumab and brentuximab as second line treatment for patients with classical hodgkins lymphoma who relapsed after chemotherapy. Any update on whether these patients would still need a stem cell transplant or is the immunotherapy alone effective?

Dear Patricia, we sent your question to Dr. Younes, who replied, "At the present time, autologous stem cell transplant is the best curative strategy for patients with relapsed HL. So at the present time we recommend that responding patients to nivolumab + brentuximab vedotin should be consolidated with the transplant." Thank you for your comment.

Does this work after exhausting all Chemo and trying brentuximab?
We have tried to get remission to do Stem Cell Transplant. Remission only last a couple of weeks.

Dear Delana, unfortunately we are not able to answer medical questions on our blog. We recommend that you discuss this with your or the patient's healthcare team. If you are interested in a consultation at MSK, you can call 800-525-2225 or go https://www.mskcc.org/experience/become-patient/appointment for more information. Thank you for your comment.

Greetings,

Are there any clinical trials for immunotherapy before auto stem cell transplant that I qualify for? I am about to begin I,C,E for refractory disease, adn frankly, I am scared of getting transplant.

I was treated for Hodgkin's Lymphoma with A,V,D (B omitted due to inability to tolerate lung toxicity). the disease recurred in my right lilac bone in less than 90 after treatment. Before I was diagnosed with Hodgkin's, about 18 months before that, I was living abroad, where I was misdiagnosed with LCH; after bone mass excision, lymphnode biopsy, radiotherapy, and ARA-C chemotherapy, I was not getting better. When my medical resources in that country were depleted, I returned the Missouri, had a lymphnode removed and I was confirmed as having HL. The original biopsy slides of bone and lymphnode were shipped to the US and HL was found in all samples, while the bone samples had HL and LCH.

Dear Amiyn, we're sorry to hear you're going through this. If you would like to speak to someone at MSK about which trials you may qualify for, you can call 800-525-2225 or go to https://www.mskcc.org/experience/become-patient/appointment for more information on making an appointment. Thank you for your comment, and best wishes to you.

It’s very reassuring to know there is new treatment available for refractory HL. I received excellent care for my HL stage 11A in 2007 at MSK . Dr John Gericitano and Dr Yahalom were my physicians. I’m happy to say I’m still cancer free !!

Dear Paula, we're happy to hear you're doing well. Best wishes to you!

Why not create and test such new drugs with minimal side effects for primary use instead of the chemo/radiation treatments, which are so hard on the body?

Dear Jennie, many of MSK's efforts are focused in this area. Being able to create effective drugs with fewer side effects is everyone's goal. However, before a new treatment becomes part of the standard of care, it is evaluated in a controlled clinical trial against the current standard -- which in most cases is chemotherapy and/or radiation. In addition, some of these newer drugs work better in combination with older treatments, such as chemotherapy and radiation.

You can learn more about clinical trials here: https://www.mskcc.org/cancer-care/clinical-trials/what-clinical-trial

Thank you for your comment.

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