Opdivo showed a 52% progression-free survival advantage over Adcetris in newly diagnosed Hodgkin’s lymphoma, according to a Phase III study that combined either therapy with doxorubicin, vinblastine and dacarbazine.
Bristol Myers Squibb’s Opdivo leads to better survival outcomes in patients with stage 3 or 4 newly diagnosed Hodgkin’s lymphoma, compared with Pfizer and Seagen’s antibody-drug conjugate Adcetris, according to late-stage results published Wednesday in The New England Journal of Medicine.
The Phase III study combined BMS’ PD-1 blocker with doxorubicin, vinblastine, and dacarbazine, more commonly known as the AVD regimen. The trial then compared the combination treatment against Adcetris plus AVD, assessing for the primary endpoint of progression-free survival.
After a median follow-up of 12.1 months, patients in the Opdivo arm saw a 52% reduction in the risk of disease progression or death, compared with Adcetris counterparts. This effect was statistically significant, with a p-value of 0.001, according to the NEJM study.
Researchers performed another survival analysis after 2.1 years of follow-up, documenting a 92% progression-free survival in the Opdivo group at that time point, versus 83% in the Adcetris arm.
“The goal of this study was to improve the cure rate while also minimizing side effects and long-term toxicities—and that’s what makes this an unprecedented clinical trial,” study lead Jonathan Friedberg, director of the Wilmot Cancer Institute at the University of Rochester Medical Center, said in a statement.
The paper found that immune-related toxicities were “infrequent” in the Opdivo group, while those given the Adcetris regimen were more likely to drop out of the study.
“We will see many less breast cancers 20 to 30 years later in this group of patients, less infertility, less heart disease,” Friedberg said, pointing out that around a third of the study’s participants were pediatric patients, who are typically treated with radiation therapy that—though often successful—leads to a heavy burden of side effects.
Opdivo is a human IgG4 monoclonal antibody that works by targeting and binding to the PD-1 ligand, blocking its interaction with its corresponding receptor. Through this mechanism of action, Opdivo prevents cancer cells from suppressing the body’s anti-tumor response.
The treatment is approved for various cancers, including melanoma, lung cancer and renal cell carcinoma. In Hodgkin’s lymphoma, Opdivo is cleared for patients who relapse or those whose diseases progress after treatment with autologous hematopoietic stem cell transplantation plus Adcetris, or at least three lines of systemic therapy.
Opdivo is not yet approved as a first-line treatment option in Hodgkin’s lymphoma.
While the FDA will ultimately determine whether Opdivo should be added as standard treatment for stage 3 or 4 Hodgkin lymphoma, Friedberg said that because the monoclonal antibody is already approved for other indications, he contends it will quickly become part of treatment guidelines and regular care.
