Opdivo Shows Benefit in Classical Hodgkin Lymphoma

Updated trial data shows that Opdivo had a high objective response rate for a cohort of patients with classical Hodgkin Lymphoma.
JASON M. BRODERICK @jasoncology
PUBLISHED: OCTOBER 27, 2016
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Opdivo (nivolumab) had a 73 percent objective response rate (ORR) for patients with classical Hodgkin lymphoma (cHL) who received Adcetris (brentuximab vedotin) before and/or after autologous hematopoietic stem cell transplantation (AHSCT), according to updated results from the CheckMate-205 trial.

The updated data are consistent with prior results from a separate CheckMate-205 cohort which supported the FDA’s May 2016 approval of Opdivo for patients with cHL who relapse or progress after AHSCT and post-transplantation Adcetris. The latest findings were presented at 10th International Symposium on Hodgkin Lymphoma (ISHL) in Cologne, Germany.

“These data…build on existing evidence supporting the benefit of Opdivo in classical Hodgkin lymphoma patients who have relapsed or progressed after autologous hematopoietic stem cell transplantation and posttransplantation brentuximab vedotin,” Andreas Engert, M.D., study investigator and professor of Internal Medicine, Hematology and Oncology, University Hospital of Cologne, Germany, said in a statement.

“[The latest results] indicated a benefit with Opdivo regardless of the order of prior treatment with autologous hematopoietic stem cell transplantation and brentuximab vedotin, providing important insights as we continue researching the potential role Opdivo could provide for heavily pretreated classical Hodgkin lymphoma patients,” added Engert.

The open-label phase 2 CheckMate-205 trial included three primary cohorts: 63 patients who received AHSCT but were Adcetris –naïve (cohort A); 80 patients treated with AHSCT followed by Adcetris (cohort B); and 100 patients who received Adcetris before and/or after AHSCT (cohort C). A fourth cohort (D), which is now enrolling patients, is examining Opdivo combined with chemotherapy as a frontline regimen in newly diagnosed patients with advanced cHL.

All patients in the trial received Opdivo at 3 mg/kg IV every two weeks until progression or unacceptable toxicity. Patients in cohort C were also treated until complete response (CR) lasting one year as per investigator assessment. The primary endpoint was ORR per assessment by an independent radiologic review committee.

The data presented at the ISHL were the outcomes from cohort C. The 73 percent (73 patients) ORR in this cohort was observed after a median follow-up of 8.8 months and was consistent regardless of the timing of Adcetris relative to AHSCT. In patients who received Adcetris before AHSCT, after AHSCT, or both, the ORR was 70 percent, 72 percent and 88 percent, respectively.

The CR rate was 17 percent (17 patients) in the overall cohort C population and the partial response (PR) rate was 56 percent (56 patients). The median duration of response was seven months. The six-month progression-free survival (PFS) rate, six-month overall survival (OS) rate, and median PFS were 76.6 percent, 93.9 percent and 11.2 months, respectively.



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