Nivolumab Granted Accelerated Approval for the Treatment of Classical Non-Hodgkin Lymphoma

The Backstory

On May 14, 2014, the immunotherapy drug nivolumab (Opidivo) received the FDA Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma whose disease relapsed after autologous stem cell transplant and treatment with brentuximab vedotin. Almost exactly two years later, on May 17, 2016, the FDA granted nivolumab accelerated approval for the treatment of people with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin

What is nivolumab?

Nivolumab is the first PD-1 blocking antibody approved for the treatment of a hematologic malignancy. Nivolumab inhibits a protein called PD-1. PD-1 primarily functions as an immune checkpoint, reducing the body’s natural immune response. PD-1 blockers like nivolumab interfere with PD-1 function and allow a person’s own immune system to destroy cancer cells; i.e., PD-1 blockers help the immune system to kill cancer.

Why did the FDA grant nivolumab the accelerated approval designation?

Nivolumab was granted an accelerated approval by the FDA based on results from two clinical trials in adults with relapsed or refractory Hodgkin lymphoma. In one study of 95 patients that had previously undergone autologous stem cell transplantation and brentuximab vedotin, 65% of people responded to nivolumab, with this response lasting almost 9 months on average. The FDA evaluated the safety of nivolumab in 263 patients treated on the second study. As is the case with all accelerated approvals, continued approval will be contingent upon the confirmed clinical results of a randomized phase III trial.

Were there any side effects?

Immune-mediated side effects occurred in 1% to 5% of patients and included rash, pneumonitis (inflammation of the lung), hepatitis (inflammation of the liver), hyperthyroidism, and colitis (inflammation of the intestine). Serious side effects were reported by 21% of patients. Additionally, the FDA issued a “Warning and Precaution” notice for patients who receive nivolumab followed by an allogeneic stem cell transplant. This was due to an increase in complications after allogeneic transplant that may be related to nivolumab. The FDA advises health care professionals to closely follow patients who receive nivolumab followed by allogeneic stem cell transplant for any complications. They have also required further study on the safety of allogeneic HSCT after nivolumab by the drug sponsor.

How can you access nivolumab now?

As an FDA approved drug, nivolumab can be prescribed by any qualified health care professional.

In addition to standard clinical use, at Weill Cornell Medicine we are continuing to study nivolumab and other immunotherapy drugs. For more information about nivolumab or immunotherapy drugs in general, please contact us at 212-746-2919 to make an appointment or with any questions regarding clinical trials or sign up for our newsletter.

Dr. Lisa Roth Describes a Clinical Trial Testing Nivolumab in Patients with Hodgkin Lymphoma who Relapsed after an Autologous Stem Cell Transplant

In this video Dr. Lisa Roth explains the benefits of a phase II trial for men and women with Hodgkin lymphoma whose disease has relapsed after an autologous stem cell transplant. The purpose of this study is to evaluate the clinical benefits of nivolumab in people with relapsed Hodgkin lymphoma. This trial is sponsored by Bristol-Myers Squibb.

If you’re interested in participating in this trial please call 646-962-2074 for more information. A full listing of Hodgkin lymphoma trials at Weill Cornell Medical College can be found here.

New Clinical Trial: Nivolumab in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) that have Either Failed or are Not Eligible for Autologous Stem Cell Transplant

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with relapsed or refractory diffuse large B-cell lymphoma, that have either failed or are not eligible for Autologous Stem Cell Transplant. The study sponsor is Bristol-Myers Squibb, and the principal investigator at Weill Cornell is Dr. John Leonard. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women equal to or greater than 18 years of age
  • A performance status of 0 or 1
  • Biopsy confirmation of relapsed, refractory DLBCL, or transformed lymphoma (TL) prior to the initiation of study drug
  • Prior treatment as defined below:
    – Subjects with relapsed or refractory DLBCL or TL after high-dose conditioning chemotherapy and ASCT, or
    – Subjects with relapsed or refractory DLBCL or TL after at least 2 prior multi-agent  chemotherapy regimens if ASCT ineligible. Ineligibility for ASCT will be determined  using local institutional criteria
  • Detailed eligibility reviewed when you contact the study team

Study Details

This clinical trial is testing a drug called Nivolumab (also known as BMS-936558, a monoclonal antibody) as therapy for subjects with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) after failure of autologous stem cell transplant (ASCT). The purpose of this study is to test the effectiveness, safety, and tolerability of the investigational drug Nivolumab.

Subjects enrolled on this study will receive Nivolumab 3 mg/kg intravenously on the start of every 2 week cycle.  The study medication may be interrupted, withheld or stopped for different reasons. However, subjects will be asked to follow up periodically for two years after ending treatment.