FDA Approves Nivolumab Plus Ipilimumab and Chemotherapy for First-Line Treatment of Stage 4 Non-Small Cell Lung Cancer

On 26 May 2020, the ADB Food and Drug Administration (FDA) approved nivolumab (Opdivo) plus ipilimumab (Yervoy) and 2 cycles of platinum-based doublet chemotherapy for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC). Patients should also have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

The CHECKMATE-9LA Study

The efficacy of this dual immunotherapy was investigated in patients with metastatic or recurrent NSCLC in a randomized, open-label clinical trial called CHECKMATE-9LA. Patients were randomly assigned to one of two arms to receive nivolumab plus ipilimumab and 2 cycles of platinum-based doublet chemotherapy (361 patients) or a combination of platinum-based doublet chemotherapy for 4 cycles (358 patients).

The study demonstrated a statistically significant benefit in overall survival in patients treated with nivolumab plus ipilimumab plus chemotherapy compared with those receiving chemotherapy:

• Median overall survival was 14.1 months in the immunotherapy + chemotherapy arm and 10.7 months in the chemotherapy-only arm.
• Adding immunotherapy to first-line treatment in this group of patients reduced the risk of death by 31% (HR 0.69; 96.71% Cl: 0.55, 0.87).
• The median value measured by a blinded independent central review center for progression-free survival (PFS) was 6.8 months in the nivolumab plus ipilimumab and chemotherapy arm and 5 months in the chemotherapy arm (HR 0.70; 95% CI: 0.57, 0.86).
• The confirmed overall response rate was 38% and 25%, respectively.
• The median duration of response was 10 months in the nivolumab plus ipilimumab and chemotherapy arm and 5.1 months in the chemotherapy arm.

The most common adverse reactions (in ≥20%) in patients receiving nivolumab together with ipilimumab and platinum-doublet chemotherapy were fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation and itching (see immunotherapy side effects).

The recommended nivolumab dose for this indication is 360 mg every 3 weeks, with an ipilimumab dose of 1 mg / kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy. Nivolumab and ipilimumab are continued for up to 2 years in patients without disease progression or unacceptable side effects.

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