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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.