Opdivo Plus ASCT Ably Treats Classical Hodgkin’s Lymphoma Patients with Few Options, Study Says

Opdivo Plus ASCT Ably Treats Classical Hodgkin’s Lymphoma Patients with Few Options, Study Says

Classical Hodgkin’s lymphoma patients who failed to respond to autologous stem cell transplant (patient-derived cells) showed “unprecedented” low relapse rates after being given Opdivo (nivolumab) followed by an allogeneic, or donor-derived, stem cell transplant, a study shows.

These findings were presented at the recent International Symposium on Hodgkin Lymphoma 11, which took place in Cologne, Germany. The study was titled, “Allogeneic stem cell transplantation (Allo-SCT) for relapsed/refractory classical Hodgkin lymphoma (cHL) patients treated with nivolumab is associated with an unprecedented low relapse rate” (page 41-2).

The immune checkpoint inhibitor Opdivo has shown promising response rates in classical Hodgkin’s lymphoma patients treated with autologous stem cell transplant (auto-SCT) — a procedure where a patients receives stem cells from their own blood  after high-dose chemotherapy – and/or Adcetris (brentuximab vedotin).

But the disease returns or progresses in a significant proportion of patients who reached complete or partial remission after Opdivo — showing they responded to this PD-1 inhibitor. At that point, they have limited treatment options.

Researchers aimed to determine if a donor-derived stem cell transplant could be of benefit as a consolidation therapy.

They studied 37 patients who were being treated with Opdivo as part of the CheckMate-205 Phase 2 trial (NCT02181738) and the CA209-254 Expanded Access Program. All had failed prior treatments, including an auto-SCT (89%) or Adcetris (86%).

After receiving Opdivo for a median of 10 months, 16 patients had a partial or complete tumor reduction, and 14 of them underwent an allogeneic stem cell transplant (ASCT). Among the 21 patients with progressive disease on Opdivo, 13 also had an ASCT after responding to additional chemotherapy or radiation therapy.

Transplants were given a median of 47 days after Opdivo’s last dose. Among the 27 patients given ASCT, 18 were in complete remission, eight were in a partial remission — their tumor burden had reduced by over 80% — and one had progressive disease.

Five transplant patients died post-ASCT, either because their disease progressed or due to non-relapse causes — graft versus host disease, cytomegalovirus infection, pneumonia, heart failure, or a secondary lymphoproliferative disorder.

Still, the incidence of relapse over a two-year period was found to be 12%, and only 10% of patients experienced a serious or life-threatening graft versus host disease — a condition in which transplanted cells attack a patient’s own healthy tissues.

After two years, 74% of these patients were still alive, and 75% had no signs of disease progression.

ASCT “after nivolumab [Opdivo] or nivolumab plus chemotherapy has a manageable toxicity and is associated with an unprecedented low relapse incidence,” the researchers concluded. “PD-1 inhibitors represent a paradigm shift in the treatment of relapsed and refractory [classical Hodgkin lymphoma].”

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