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Nivolumab/Ipilimumab Approved for Metastatic Non-Small Cell Lung Cancer

Non-small cell lung cancer.

For patients with advanced non-small cell lung cancer (NSCLC) that test positive for programmed death-ligand 1 (PD-L1), the FDA just approved an effective treatment: nivolumab (Opdivo ®, Bristol Myers Squibb) plus ipilimumab (Yervoy®, Bristol Myers Squibb). A companion diagnostic, PD-L1 IHC 28.8 pharmDx (Agilent Technologies, Inc.), was also FDA approved for selecting patients with NSCLC for treatment with nivolumab/ipilimumab.

Previously approved to treat advanced kidney cancer, advanced liver cancer, colorectal cancer, melanoma, and head and neck squamous cell cancer, among others, nivolumab is an immunotherapy that acts as a radar to help immune cells find cancer cells in order to destroy them. Ipilimumab, currently approved for metastatic melanoma, is another immunotherapy drug that activates immune cells so they can eradicate cancer cells. Together, nivolumab and ipilimumab activate immune cells to find and attack cancer cells.

Efficacy of nivolumab plus ipilimumab was shown in the phase 3 CheckMate 227 trial (NCT02477826). For this study, results of which were published last November in The New England Journal of Medicine, 1,189 treatment-naive patients with stage IV or recurrent NSCLC and a PD-L1 expression level of at least 1% were randomized in a 1:1:1 ratio to receive either nivolumab/ipilimumab, nivolumab monotherapy, or chemotherapy.

Patients who received nivolumab/ipilimumab experienced a greater 1-year progression-free survival rate compared with those who received chemotherapy (42.6% vs 13.2%), with a longer median progression free-survival (7.2 months vs 5.5 months). The objective response rate was higher with nivolumab/ipilimumab than with chemotherapy (35.9% vs 30.0%), with 1.8% of patients experiencing a complete response. In patients who received nivolumab/ipilimumab, median duration of response was also higher than those who received chemotherapy (23.2 months vs 6.2 months), and more patients taking nivolumab/ipilimumab achieved an ongoing response (64.2% vs 27.9% at 1 year and 49.5% vs 11.0% at 2 years).

Side effects of nivolumab/ipilimumab occurring in at least 20% of patients included fatigue, rash, decreased appetite, musculoskeletal pain, diarrhea, dyspnea, cough, pruritus, nausea, and hepatitis.

Recommended dosing of nivolumab/ipilimumab is as follows: 3 mg/kg nivolumab every 2 weeks and 1 mg/kg ipilimumab every 6 weeks. Continue treatment until disease progression or unacceptable toxicity or continue for up to 2 years in those without disease progression.

For More Information

Clinicaltrials.gov (2020). An investigational immune-therapy trial of nivolumab, or nivolumab plus ipilimumab, or nivolumab plus platinum-doublet chemotherapy, compared to platinum doublet chemotherapy in patients with stage IV non-small cell lung cancer (NSCLC) (CheckMate 227). NLM Identifier: NCT02477826.

Hellman MD, Paz-Ares L, Caro RB, et al (2019). Nivolumab plus ipilimumab in advanced non-small cell lung cancer. N Engl J Med, 381:2020-2031. DOI:10.1056/NEJMoa1910231

Opdivo® and Yervoy® (nivolumab and ipilimumab) prescribing information 2020. Bristol Myers Squibb. Available at: https://www.opdivo.com/advanced-nsclc-combination

Image Courtesy of Librepath. Licensed under CC BY-SA 3.0

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