Aim: To explore the safety and efficacy of nivolumab in patients with previously-treated,PD-L1+/- metastatic NSCLC.
Methods: Eligible patients were enrolled and received nivolumab 3 mg/kg IV Q2W until progressive disease/unacceptable toxicity or for 1 year with the possibility of retreatment upon disease progression. Primary objective: estimated incidence of CTCAE v4.0 Grade 3–5 select treatment-related adverse events (sTRAEs).
Results: From 4/16/14 to 12/31/14, 824 patients were treated; 483 patients remained on study as of 12/31/2014. 531patients had evaluable radiographic tumor assessments at first assessment (Week 9).
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N=824 |
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Male/female,% |
54/46 |
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Median age (range), years |
66 (33–93) |
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Squamous/non-squamous,% |
28/72 |
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PS,0–1/2/Not reported |
90/8/2 |
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Prior therapies, 1/2/≥3/Not Reported,% |
30/29/38/3 |
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PD-L1 status (n=263) <1%/≥1%,% <5%/≥5%,% |
43/57 63/37 |
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sTRAEs,%
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PS 0–1 (n=742) |
PS 2 (n=65) |
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Grade |
Any |
3–4 |
Any |
3–4 |
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Endocrine Gastrointestinal Hepatic Respiratory Skin |
6.2 6.7 3.5 0.8 9.3 |
0.3 0.4 0.5 0.3 0.4 |
0 6.2 3.1 0 9.2 |
0 0 1.5 0 1.5 |
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Overall tumor response at first assessment (N=531) By performance status PS 0–1 (n=489) PS2 (n=35) Tumor histology SQ (n=145) NSQ (n=386) |
CR 0
0 0
0 0 |
PR 63, 12%
54, 11% 7, 20%
19 (13%) 44 (11%) |
SD 233, 44%
214, 44% 16, 46%
73 (50%) 160 (42%) |
Conclusions: Safety analyses are consistent with prior nivolumab study experience and no new safety signals have been identified in this trial conducted primarily at community research sites. The frequency of the treatment-related SAEs and select AEs of interest is similar between patients with PS 0-1 and those with PS of 2. Early data from this large multicenter trial suggests that patients with pretreated advanced NSCLC have clinical benefit from nivolumab therapy regardless of histology type, performance status, EGFR/ALK mutation status, or number of prior therapies. Responses are seen in both PD-L1 positive and negative populations.