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FDA Approves Nivolumab/Ipilimumab/Platinum-Doublet Chemotherapy: NSCLC

Non-small cell lung cancer.

Nivolumab (Opdivo®, Bristol Myers Squibb) plus ipilimumab (Yervoy®, Bristol Myers Squibb) in combination with 2 cycles of platinum-doublet chemotherapy has been FDA approved for treatment-naive patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

Approval was based on the randomized, open-label trial CHECKMATE-9LA (NCT03215706). A total of 719 patients with metastatic or recurrent NSCLC were enrolled. In a randomized 1:1 ratio, participants were administered either nivolumab plus ipilimumab plus 2 cycles of platinum-doublet chemotherapy or platinum-doublet chemotherapy alone.

Not only did median overall survival improve for patients treated with nivolumab/ipilimumab plus 2 cycles of platinum-doublet chemotherapy compared with patients who received chemotherapy alone (14.1 months vs 10.7 months), but median progression-free survival (6.8 months vs 5 months) and overall response rate (38% vs 25%) were also increased in the treatment group compared with the control group. The median duration of response was 10 months for participants who received nivolumab/ipilimumab plus chemotherapy and 5.1 months in the chemotherapy alone group.

Treatment-related adverse events that occurred in greater than 20% of patients who received nivolumab plus ipilimumab in combination with platinum-doublet chemotherapy included fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.

The FDA recommends nivolumab be administered at a dose of 360 mg every 3 weeks in combination with 1 mg/kg every 6 weeks of ipilimumab plus 2 cycles of platinum-doublet chemotherapy. It is recommended that nivolumab/ipilimumab plus 2 cycles of platinum-doublet chemotherapy be administered until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression.

For More Information

Clinicaltrials.gov (2020). A study of nivolumab and ipilimumab combined with chemotherapy compared to chemotherapy alone in first line NSCLC. NLM Identifier: NCT03215706.

Opdivo® (nivolumab) prescribing information (2020). Bristol Myers Squibb. Available at: https://www.opdivohcp.com/home

US Food and Drug Administration (2020). FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC. Available at: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-plus-ipilimumab-and-chemotherapy-first-line-treatment-metastatic-nsclc

Yervoy® (ipilimumab) prescribing information (2020). Bristol Myers Squibb. Available at: https://www.yervoy.com/ 

Image Courtesy of Yale Rosen. Licensed under CC BY-SA 2.0


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