• The U.S. Food and Drug Administration (FDA) recently approved Opdivo — a formulation of nivolumab — along with chemotherapy as a treatment for non-small cell lung cancer (NSCLC) before surgery.
• Clinical trial data shows that taking nivolumab and chemotherapy together before surgery can lead to better outcomes.
• Nivolumab works with the immune system to more effectively fight cancer.

The FDA has announced that people with NSCLC may now use Opdivo combined with chemo as a neoadjuvant therapy — a treatment that is given before surgery. Opdivo is a formulation of the immunotherapy drug nivolumab, administered by IV. The medication is already approved for treating NSCLC that has metastasized to other parts of the body or returned after initial treatment. This new approval marks the first time that nivolumab can be used for early-stage NSCLC tumors before surgery.

With the new approval, Opdivo may be given along with platinum-doublet chemotherapy, which includes a platinum-based drug such as cisplatin or carboplatin, combined with another chemotherapy drug such as gemcitabine or paclitaxel.

Clinical Trial Results

The FDA’s approval of Opdivo’s new indication followed a clinical trial in people with stage 1B, 2, or 3A NSCLC. Study participants received either nivolumab plus chemotherapy or chemotherapy alone.

Study participants who took nivolumab were more likely to have good outcomes compared to those who only received chemotherapy. People using this drug were 37 percent less likely to experience disease progression (having cancer get worse), cancer recurrence (having cancer come back after being treated), or death.

Additionally, about 1 out of 4 people who took nivolumab had a pathological complete response: Researchers found no remaining cancer cells in their lung tissue or lymph nodes that were removed during surgery. On the other hand, only 2.2 percent of people who received chemotherapy alone had a pathological complete response.

In the clinical trial, side effects occurred for both groups of participants at similar rates, whether they were taking nivolumab or nivolumab plus chemotherapy. The most common side effects were:

• Nausea
• Constipation
• Tiredness
• Loss of appetite
• Rash

How Nivolumab Works

Nivolumab is a newer type of cancer therapy called an immune checkpoint inhibitor. Drugs in this category work with the immune system to help fight cancer. Normally, the immune system can help recognize and destroy cancer cells. However, cancer cells often turn on “checkpoints” that help them escape the immune system. Checkpoint inhibitors like nivolumab block PD-1, a protein that is part of the immune checkpoint process. It makes cancer cells more vulnerable to attacks from the immune system.

Dr. Mark Awad, one of the researchers who helped run the study, said that better treatments were needed to help prevent lung cancer from returning following treatment. “The approval of nivolumab with platinum-doublet chemotherapy marks a turning point in how we treat resectable NSCLC and it enables us to use immunotherapy and chemotherapy as neoadjuvant treatment for patients before surgery,” Dr. Awad said in a press release from Bristol Myers Squibb, Opdivo’s manufacturer. “Today’s announcement reinforces the need to increase the rates of NSCLC screening and early detection, and for patients to discuss treatment options with their providers.”

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