Opdivo Outperforms Adcetris in Advanced Hodgkin's Lymphoma Trial

Opdivo, a product of Bristol Myers Squibb, demonstrated a significant advantage in prolonging progression-free survival in patients with newly diagnosed stage 3 or 4 Hodgkin’s lymphoma, compared to Pfizer and Seagen’s Adcetris. This conclusion comes from a Phase III study published in The New England Journal of Medicine. The study evaluated the efficacy of combining Opdivo with the AVD regimen—comprising doxorubicin, vinblastine, and dacarbazine—against Adcetris paired with the same AVD regimen.

The trial revealed that after a median follow-up of 12.1 months, those in the Opdivo group experienced a 52% lower risk of disease progression or death than patients treated with Adcetris. This difference was statistically significant, with a p-value of 0.001. A subsequent survival analysis conducted after 2.1 years of follow-up found that 92% of patients in the Opdivo group remained progression-free, compared to 83% in the Adcetris group.

The study’s lead, Jonathan Friedberg, director of the Wilmot Cancer Institute at the University of Rochester Medical Center, highlighted the trial's goals of improving cure rates while minimizing long-term toxicities and side effects. He noted that immune-related toxicities were rare in patients receiving Opdivo, whereas those on the Adcetris regimen were more prone to discontinue the study due to adverse effects.

Friedberg emphasized the long-term benefits of reduced side effects, particularly mentioning fewer cases of breast cancer, infertility, and heart disease in the future. This is particularly significant as about one-third of the study’s participants were pediatric patients. Traditionally, these younger patients are treated with radiation therapy, which, while often effective, can cause substantial long-term side effects.

Opdivo operates as a human IgG4 monoclonal antibody that targets and binds to the PD-1 ligand, thus blocking its interaction with the receptor. This mechanism prevents cancer cells from evading the body’s immune response against tumors. Although Opdivo has gained approval for treating various cancers such as melanoma, lung cancer, and renal cell carcinoma, it is currently approved for Hodgkin's lymphoma only for patients who have relapsed or whose disease has progressed following treatment with autologous hematopoietic stem cell transplantation plus Adcetris, or after at least three lines of systemic therapy.

Presently, Opdivo is not approved as a first-line treatment for Hodgkin’s lymphoma. However, Friedberg anticipates that it will soon become a standard part of treatment protocols and regular care. This expectation is based on the antibody’s existing approval for other indications, suggesting that its integration into treatment guidelines may proceed swiftly once the appropriate regulatory decisions are made.

In summary, the Phase III study's findings suggest that Opdivo, when combined with the AVD regimen, offers a superior progression-free survival rate for patients with newly diagnosed stage 3 or 4 Hodgkin’s lymphoma compared to the Adcetris combination. This promising outcome could potentially reshape the standard of care for this patient population upon regulatory approval.