FDA Grants Priority Review to Merck’s sBLA for KEYTRUDA as Second-Line Therapy in Relapsed or Refractory Classical Hodgkin Lymphoma

Compiled by Fan Dongdong

Recently, MSD announced that the U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for Keytruda and granted it priority review status for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). The PDUFA date is October 30, 2020.

The newly released BLA is primarily based on the pivotal Phase 3 KEYNOTE-204 trial data. KEYNOTE-204 is a randomized, open-label study designed to evaluate the efficacy and safety of Keytruda monotherapy versus the standard-of-care brentuximab vedotin (BV) in patients with relapsed or refractory classical Hodgkin lymphoma (cHL). A total of 304 cHL patients aged 18 years or older were enrolled and randomly assigned to receive either Keytruda (200 mg) or BV (1.8 mg/kg, up to a maximum of 180 mg). The dual primary endpoints were progression-free survival (PFS) and overall survival (OS), while key secondary endpoints included objective response rate (ORR), complete response rate (CRR), and safety.

The results showed that the study met one of its dual primary endpoints. Compared with BV, patients in the Keytruda group demonstrated a statistically and clinically significant improvement in progression-free survival (PFS) (HR=0.65; 95% CI: 0.48–0.88; p=0.00271), with a median PFS of 13.2 months versus 8.3 months. Regarding secondary endpoints, the objective response rate (ORR) was 65.6% in the Keytruda group compared to 54.2% in the BV group; the complete response rates (CRR) were 24.5% and 24.2%, respectively; partial responses were observed in 41.1% and 30.1% of patients, respectively. The median duration of response reached 20.7 months in the Keytruda group, compared to 13.8 months in the BV group.

Furthermore, the positive trial data from KEYNOTE-204 served as the confirmatory trial for the accelerated approval of Keytruda in hematologic indications.

As its flagship product, MSD is conducting a broad range of clinical programs for Keytruda to evaluate its efficacy in various hematologic malignancies, covering 15 tumor types with up to 60 studies, including three registrational trials in classical Hodgkin lymphoma (cHL) and primary mediastinal large B-cell lymphoma (PMBCL).

Reference Source: FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) for Second-Line Treatment of Patients With Relapsed or Refractory Classical Hodgkin Lymphoma