This article is more than 5 years old. Information may no longer be current.
Nivolumab shows strong activity in classic Hodgkin’s lymphoma
SAN FRANCISCO — Immunotherapy with nivolumab yielded an 87% response rate in a cohort of patients with Hodgkin’s lymphoma, according to findings presented here.
Philippe W. Armand, MD, of the Dana-Farber Cancer Institute, and colleagues, hypothesized that nivolumab (Bristol-Myers Squibb) may augment anti-tumor activity in a cohort of 23 patients with relapsed or refractory classic Hodgkin’s lymphoma.
Patients in the phase 1 dose escalation and cohort expansion study received nivolumab 3 mg/kg every 2 weeks until confirmed tumor progression or extreme toxicity was experienced. Clinicians evaluated the PD-1 blocking antibody.
Philippe W. Armand
Safety served as the primary outcome measure. Anti-tumor activity and expression of immunomodulatory proteins in tumor biopsies were the main secondary endpoints.
Eighty-seven percent of the cohort had been treated with ≥3 prior treatment regimens, while 78% of patients had prior autologous stem cell transplant and 78% had prior brentuximab vedotin (Adcetris, Seattle Genetics) treatment.
“The cohort was quite heavily pretreated,” Armand said. “Many of them had very few alternative options available.”
Armand reported an 87% objective response rate, with 17% of patients reaching complete response and 70% achieving a partial response. The 24-week PFS rate for all patients was 86% (95% CI, 62-95).
An objective response rate of 89% was reported among 18 patients who previously failed treatment with brentuximab vedotin, with 6% reaching a complete response and 83% reaching a partial response.
“Most of the responses occurred within 8 weeks of starting study treatment,” Armand said.
No median OS was reached (range, 21+ to 75+ weeks), according to the results.
Other findings indicated that five patients experienced grade 3 adverse events.
“There were no life-threatening adverse events and no treatment-related deaths,” Armand said. “There were two adverse events leading to discontinuation.”
Armand added that the current findings parallel results seen in thousands of patients with solid tumors who were treated with nivolumab. “Importantly, we saw no apparent increase in lung toxicity,” he said.
The study is still ongoing in 48% of the cohort, and 43% of patients are still on treatment.
The researchers also attempted to observe the underlying biology behind the clinical response with an analysis of 10 tumors. “All of these tumors showed increased expression of the PD-1 ligand,” Armand said.
As a consequence of the study results, the FDA has granted nivolumab breakthrough status in patients with relapsed or refractory classic Hodgkin’s lymphoma. A multinational phase 2 trial is proceeding, according to the researchers.
For more information:
Armand P. Abstract #289. Presented at: ASH Annual Meeting and Exhibition; Dec. 6-9, 2014; San Francisco.
Disclosure: Armand reports financial relationships with Bristol-Myers Squibb and Merck.
Perspective
Back to Top
This checkpoint inhibitor aims to awaken the body’s natural immune response to cancer, enabling cancer-fighting T-cells to seek and destroy tumor cells. Ultimately, the goal is to overcome the use of chemotherapy, which blasts healthy and malignant cells alike.
Perspective
Back to Top