Efficacy

Efficacy of Polivy (polatuzumab vedotin-piiq) in Treating Lymphoma

Polivy (polatuzumab vedotin-piiq) is a monoclonal antibody-drug conjugate that targets CD79b, a protein expressed on the surface of B-cells. It has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), in combination with bendamustine and a rituximab product (a regimen known as "BR"), after at least two prior therapies. Clinical trials have demonstrated that Polivy, when added to BR, has significantly improved the outcomes in these patients. The efficacy was measured in terms of overall response rate (ORR) and complete response rate (CRR), with Polivy-containing regimens showing a higher ORR and CRR compared to BR alone.

In the pivotal phase II study that led to its approval, the addition of Polivy to BR resulted in a 40% complete response rate, which was a significant improvement over the 17.5% rate observed with BR alone. The median duration of response for patients treated with the Polivy combination was also notably longer. These results suggest that Polivy can be an effective component of therapy for patients with relapsed or refractory DLBCL, offering a chance for better outcomes in a population with limited treatment options.

Efficacy of Xpovio (selinexor) in Treating Lymphoma

Xpovio (selinexor) is a first-in-class, oral selective inhibitor of nuclear export (SINE) compound that blocks the nuclear export protein XPO1. This leads to the accumulation of tumor suppressor proteins in the cell nucleus, restoring their ability to halt tumor growth and cause tumor cell death. Xpovio has been granted accelerated approval by the FDA for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. The approval was based on the response rate demonstrated in clinical trials.

The efficacy of Xpovio in DLBCL was evaluated in a multicenter, single-arm clinical trial, where a subset of heavily pretreated patients with relapsed or refractory DLBCL demonstrated an ORR of 28%, with a 12% complete response rate. While the median duration of response was modest, the ability of Xpovio to induce responses in a difficult-to-treat population provides a valuable treatment option for patients who have exhausted other therapies. Ongoing studies are expected to provide further insight into the long-term benefits and optimal use of Xpovio in the management of lymphoma.