Changing the Treatment Dynamic: FDA Approves Nivolumab for NSCLC

The FDA has approved nivolumab (Opdivo) for the treatment of patients with advanced squamous non–small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy.

The FDA has approved nivolumab (Opdivo) for the treatment of patients with advanced squamous non—small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. The approval, which comes 3 months ahead of the FDA’s scheduled decision date, is the first PD-1 inhibitor to be approved for lung cancer.

“It’s about time we revolutionize our approach to lung cancer treatment,” said Bonnie J. Addario, 10-year lung cancer survivor and founder of the ALCF. “Lung cancer is the most commonly diagnosed cancer and has one of the highest mortality rates. There is significant need for treatment options that benefit patients and increase survival rates. This is a huge step in the right direction.”

The approval is based on data from the phase III CheckMate-017 trial in which nivolumab improved overall survival (OS) by 3.2 months versus docetaxel in previously treated patients with advanced or metastatic squamous cell NSCLC.

The phase III open-label CheckMate-017 study involved 272 previously treated patients with advanced or metastatic squamous cell NSCLC. Participants were randomized to the fully human IgG4 monoclonal antibody nivolumab at 3 mg/kg intravenously every 2 weeks (n = 135) or docetaxel at 75 mg/m2 (n = 137) intravenously every 3 weeks.

Treatment with nivolumab improved OS by 41% versus docetaxel (9.2 vs 6.0 months; HR = 0.59; 95% CI, 0.44-0.79; P = .00025).

The approval was also supported by data from the open-label, single-arm, phase II CheckMate-063 study of nivolumab in NSCLC, which were presented at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology.

The study included 117 heavily pretreated patients with advanced squamous cell NSCLC. All patients had failed two or more systemic treatments and 65% of participants (n = 76) had previously failed three or more treatments. Seventy-six percent of patients were within 3 months of completion of their most recent therapy.

Understanding the Side-Effect Profile

Rajni Kannan, MS, RN, ANP-BC, a nurse practitioner at the Perlmutter Cancer Center at NYU Langone Medical Center in New York has worked with nivolumab in the melanoma setting and said when it comes to working with PD-1 inhibitors and immunotherapies, it’s important for nurses to understand the mechanism of action of these drugs in order to explain it to patients, but also to understand it themselves.

“The side effects make sense when you understand how the drug works on the immune system,” she said. “It really is a nursing drug in the fact that that’s who’s going to be educating the patient and communicating with the patient about their side effects.”

Because the side effects of these PD-1 agents are different than what nurses and patients are used to seeing with chemotherapy, radiation, or other standard therapies, it’s really important to communicate with the patients, Kannan said.

“This is not a drug where patients have a side effect, you treat them or the side effect and then you don’t communicate with them—there’s actually constant communication.”

In the trials, grade 3/4 drug-related adverse events (AEs) were reported in 17% of patients. The most common (≥2%) grade 3/4 AEs were fatigue (4.3%), pneumonitis (3.4%), and diarrhea (2.6%).

Discontinuations due to drug-related AEs of any grade occurred in 12% of patients. Two drug-related deaths (1 hypoxic pneumonia, 1 ischemic stroke) occurred in patients with multiple comorbidities and progressive disease.

Kannan says nurses must pay close attention in lung cancer patients being treated with nivolumab to try to determine when pneumonitis is being caused from the disease or by the therapy.

A New Way of Treating Patients

“I think that people are so used to chemotherapy...this is a new way with less immune toxicities,” she said. “It’s a new way of treating lung cancer and it’s a new option, which is what we saw in melanoma...having one more therapy to give quality as well as quantity really does change how patients feel and do.”

And even if you don’t work with melanoma or lung cancer patients, Kannan said it’s important to pay attention to these new PD-1 therapies.

“I think it’s changing...the dynamic of how we treat cancer in general by stimulating the immune system versus using chemotherapy,” she said. “So that’s changed the way we manage side effects but as well as what we’re seeing in response rates in both melanoma and lung.”

“It really is the launching block right now to open up to many other types of cancers soon,” she added.