Dr Wong on the FDA Approval of Vusolimogene Oderparepvec-wtpg Plus Nivolumab in Melanoma

“With the approval of [vusolimogene oderparepvec] plus nivolumab, [the combination] will fit into the post-PD-1 immunotherapy–refractory space.”

Michael Wong, MD, PhD, FRPC, former physician-in-chief at Roswell Park Comprehensive Cancer Center, discussed the FDA accelerated approval of vusolimogene oderparepvec-wtpg (Tudriqev), a genetically modified oncolytic viral therapy, in combination with nivolumab (Opdivo) for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a PD-1–blocking antibody-based regimen.

The approval of vusolimogene oderparepvec in combination with nivolumab introduces a new treatment option for patients with melanoma whose disease has progressed following prior PD-1–based immunotherapy, Wong began. This combination is expected to fill an important therapeutic niche in the post–PD-1 refractory setting, where treatment options have historically been limited, he noted. Until now, the only FDA-approved therapy specifically available for these patients has been tumor-infiltrating lymphocyte (TIL) therapy, he added.

Although both vusolimogene oderparepvec plus nivolumab and TIL therapy are intended for patients with immunotherapy-refractory disease, they are likely to serve different patient populations, Wong explained. TIL therapy has demonstrated clinical benefit and represents an important advancement in adoptive cellular therapy. However, its complexity limits its applicability for many patients, he said. The treatment process requires surgical harvesting of tumor tissue, ex vivo manufacturing of the TIL product, administration of lymphodepleting chemotherapy to eliminate existing immune cells, infusion of the engineered TILs, and subsequent treatment with high-dose IL-2. These multiple steps require significant institutional resources and patient fitness, making TIL therapy most appropriate for carefully selected individuals, he noted.

In contrast, vusolimogene oderparepvec plus nivolumab offers a less complex treatment approach that may be accessible to a broader group of patients, Wong said. Although careful patient selection will remain important, the regimen does not require the extensive manufacturing process, hospitalization, or intensive supportive care associated with cellular therapies. As a result, it has the potential to be implemented more readily across a wider range of treatment settings, he concluded.