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FDA Approves Nivolumab for Small Cell Lung Cancer

Jason M. Broderick @jasoncology
Published: Friday, Aug 17, 2018

The FDA has granted an accelerated approval to single-agent nivolumab (Opdivo) for the treatment of patients with small cell lung cancer (SCLC) with disease progression following platinum-based chemotherapy and 1 other line of therapy.

The ORR in the single-agent nivolumab arm was 10% (95% CI, 5-18), and the ORRs were 23% (95% CI, 13-36) and 19% (95% CI, 9-31) in the N1/I3 and N3/I1 arms, respectively. Responses generally consisted of partial responses, with 1 complete response seen in the N1/I3 arm. Stable disease rates were 22%, 21%, and 17%, in the single-agent, N1/I3, and N3/I1 arms, respectively. Across arms, both platinum-sensitive and -resistant patients responded to treatment.

The median DOR was not yet reached with single-agent nivolumab. In the N3/I1 group, the median DOR was 4.4 months (95% CI, 3.7-not reached). In the N1/I3 group, the median DOR was 7.7 months (95% CI, 4.0-not reached).

Overall, 69% of patients were evaluable for PD-L1 expression at baseline, with 17% expressing the ligand on ≥1% of cells. Responses were seen regardless of PD-L1 expression. Sixteen patients experienced a DOR of more than 6 months, 50% of which were in the N1/I3 group.

AEs were more common in the combination arms versus the single-agent. All-grade AEs were experienced by 53% of those in the monotherapy arm, with a grade 3/4 AE rate of 13%. In the N3/I1 and N1/I3 arms, 74% and 79% of patients experienced AEs of any grade, respectively. Grade 3/4 AEs occurred in 19% and 30% of patients, in the N3/I1 and N1/I3 groups, respectively.

AEs led to treatment discontinuation for 6%, 7%, and 11% of patients in the monotherapy, N3/I1, and N1/I3 arms, respectively. Two treatment-related deaths occurred in the N1/I3 arm from myasthenia gravis and renal failure and 1 death was seen in the N3/I1 arm from pneumonitis. Treatment-related limbic encephalitis occurred in 2 patients and resolved in 1.

“At Bristol-Myers Squibb, we recognize the critical need to provide patients with cancer therapies that may offer more durable responses – particularly for those living with hard-to-treat, aggressive diseases like small cell lung cancer,” Sabine Maier, MD, development lead, thoracic cancers, Bristol-Myers Squibb, said in a statement. “This approval builds on our heritage of bringing Immuno-Oncology therapies to patients with other types of thoracic cancers. It also reinforces our commitment to bringing transformative treatments to patients in urgent need of effective new options.”

The approval, which is the first for SCLC in nearly 20 years, is contingent on findings from a confirmatory study.


  1. Antonia SJ, Lopez-Martin JA, Bendell JC, et al. Checkmate 032: Nivolumab (N) alone or in combination with ipilimumab (I) for the treatment of recurrent small cell lung cancer (SCLC). J Clin Oncol. 2016;34 (suppl; abstr 100).
  2. Antonia SJ, Lopez-Martin JA, Bendell JC, et al. Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial [published online June 4, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(16)30098-5.


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