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Table 1

From: Phase I/II study of nivolumab with or without ipilimumab for treatment of recurrent small cell lung cancer (SCLC): CA209-032

 

Nivolumab (n-40)

Nivolumab + Ipilimumab (n=46)a

ORR, %

18

17

 Complete response, %

0

2.2

 Partial response, %

18

15

 Stable disease,b %

20

37

 Disease control rate, %

38

54

 Progressive disease, %

53c

37

Death prior to first response assessment, %

10

6.5d

Not evaluable (no tumor assessment follow-up), %

0

2.2e

Median time to objective response (months)

1.6

2.2

Median DOR, months (95% CI) Range

NR 4.1-11+

6.9 (1.5 NR) 1,5-11,1+

  1. DOR=duration of response; NR=not reached.
  2. a4 of 50 patients did not reach first tumor assessment at database lock.
  3. bOf 17 patients with stage disease in the nivolumab + ipilimumab arm, 7 had confirmed partial response after databse lock, resulting in updated ORR of 32.6%.
  4. c1 patient had progressive disease in the spine, requiring surgery.
  5. d1 patient died due to an unrelated adverse event, 1 patient died due to treatment-related myasthenia gravis, 1 patient died due to progressive disease.
  6. e1 patient had an unrelated adverse event leading to permanent discontinuation, and had no post-baseline tumor assessment.