Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to pembrolizumab for the second-line treatment of patients with relapsed or refractory Hodgkin lymphoma, and also accepted a supplemental new drug application for selinexor for pretreated patients with multiple myeloma.
Priority Review for Pembrolizumab in the Second-Line Treatment of Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
The FDA accepted and granted Priority Review for a new supplemental biologics license application for pembrolizumab, an anti–PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma. The FDA has set a Prescription Drug User Fee Act, or target action, date of October 30, 2020.
The application is based on data from the pivotal phase III KEYNOTE-204 trial, in which pembrolizumab demonstrated a significant improvement in progression-free survival compared to brentuximab vedotin, a current standard of care in this patient population. The dual primary endpoints are progression-free survival and overall survival; key secondary endpoints include objective response rate, complete remission rate, and safety.
The study enrolled 304 patients age 18 and older who were randomly assigned to receive either 200 mg of pembrolizumab intravenously on day 1 of each 3-week cycle for up to 35 cycles, or 1.8 mg/kg of brentuximab vedotin (maximum = 180 mg per dose) intravenously on day 1 of each 3-week cycle for up to 35 cycles. Per the prespecified analysis plan, the other dual primary endpoint of overall survival has not been formally tested yet; the study will continue to evaluate overall survival.
KEYNOTE-204 also serves as the confirmatory trial for the pembrolizumab accelerated approval hematology indications. Data from KEYNOTE-204 were recently presented by Kuruvilla et al at the ASCO20 Virtual Scientific Program (Abstract 8005).
Supplemental New Drug Application for Selinexor in Patients With Pretreated Multiple Myeloma
The FDA accepted a supplemental new drug application seeking approval for selinexor, a first-in-class, oral selective inhibitor of nuclear export compound, as a new treatment for patients with multiple myeloma after at least one prior line of therapy. A decision from the FDA regarding the application is expected before the end of the first quarter of 2021.
Selinexor has been previously approved by the FDA for the treatment of patients with pentarefractory multiple myeloma and relapsed or refractory diffuse large B-cell lymphoma.
Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies, in liposarcoma, and in endometrial cancer, among others.
