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Nivolumab in Relapsed or Refractory DLBCL Ineligible for or After Failure of Autologous Transplantation

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Key Points

  • Response rates were 10% among failed transplantation patients and 3% among transplantation-ineligible patients.
  • Median response durations were 11 and 8 months in the 2 cohorts.

In a phase II trial reported in the Journal of Clinical Oncology, Ansell et al found that nivolumab was associated with low response rates among patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who were ineligible for or experienced failure of autologous hematopoietic cell transplantation (HCT).

Study Details

In the multicenter study, patients who were ineligible for (n = 34) or had experienced failure with autologous HCT (n = 87) received nivolumab 3 mg/kg every 2 weeks. Patients in the autologous HCT–failed cohort received a median of four nivolumab doses, and those in the autologous HCT–ineligible cohort received a median of three doses.

Response Rates

Median follow-up was 9 months in the autologous HCT–failed cohort and 6 months in autologous HCT–ineligible cohort. Response rates on independent assessment were 10% and 3%, with median durations of response of 11 and 8 months. Median progression-free survival was 1.9 and 1.4 months, and median overall survival was 12.2 and 5.8 months.

Three patients in the autologous HCT–failed cohort with complete remission had response durations of 11+, 14+, and 17 months. Stable disease or better response was observed in 31% of the autologous HCT–failed cohort.

Analysis of alterations of chromosome 9p24.1 (which contains the genes that code for programmed cell death 1 and its ligands PD-L1/PD-L2) showed that among 74 evaluable samples, 16% exhibited low-level copy gain and 3% had amplification. One of the three patients with complete remission had high-level 9p24.1 amplification, with the other two having normal 9p24.1copy number or no available biopsy specimen. Of the seven patients with partial remission, five with available biopsy specimens had normal 9p24.1 copy numbers (one patient), low-level polysomy (three patients), or copy gain (one patient).

Adverse Events

Treatment-related grade 3 or 4 adverse events were reported in 24% of patients, with the most common being neutropenia (4%), thrombocytopenia (3%), and increased lipase (3%). Treatment-related serious adverse events were reported in 12% of patients.

The investigators concluded: “Nivolumab monotherapy is associated with a favorable safety profile but a low overall response rate among patients with DLBCL who are ineligible for autologous HCT or who experienced failure with autologous HCT. Genetic alterations of 9p24.1 are infrequent in DLBCL.”

Stephen M. Ansell, MD, PhD, of the Mayo Clinic, Rochester, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by Bristol-Myers Squibb and others. The study authors’ full disclosures can be found at jco.ascopubs.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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