Safety and efficacy of nivolumab in an ongoing trial of a PD-L1<sup>+/-</sup> patient population with metastatic non-small cell lung cancer — ASN Events
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Safety and efficacy of nivolumab in an ongoing trial of a PD-L1+/- patient population with metastatic non-small cell lung cancer (#201)

Maen Hussein 1 , Michael McCleod 2 , Jason Chandler 3 , George Blumenschein, Jr 4 , Lee Schwartzberg 3 , Howard Burris 5 , David Waterhouse 6 , Robert Jotte 7 , Todd Bauer 5 , Dana Thompson 5 , Xuemei Li 8 , Craig Reynolds 9
  1. Florida Cancer Specialists, Lady Lake, FL, USA
  2. Florida Cancer Specialists, Cape Coral, FL, USA
  3. The West Clinic, P.C., Memphis, TN, USA
  4. University of Texas MD Anderson Cancer Center, Houston, TX, USA
  5. Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN, USA
  6. Oncology Hematology Care, Cincinnati, OH, USA
  7. Rocky Mountain Cancer Centers, Denver, CO, USA
  8. Bristol-Myers Squibb, Princeton, NJ, USA
  9. Ocala Oncology Center, Ocala, FL, USA

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).

 

N=824

Male/female,%

54/46

Median age (range), years

66 (33–93)

Squamous/non-squamous,%

28/72

PS,0–1/2/Not reported

90/8/2

Prior therapies, 1/2/≥3/Not Reported,%

30/29/38/3

PD-L1 status (n=263)

<1%/≥1%,%

<5%/≥5%,%

 

43/57

63/37

sTRAEs,%

 

PS 0–1 (n=742)

PS 2 (n=65)

Grade

Any

3–4

Any

3–4

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

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.

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