European Commission Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Adult and Pediatric Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)

• KEYTRUDA as Monotherapy Now Approved for Adult and Pediatric Patients Aged 3 years and Older with Relapsed or Refractory cHL Who Have Failed Autologous Stem Cell Transplant (ASCT) or After Two or More Lines of Therapy When ASCT is Not a Treatment Option
• First Pediatric Indication for KEYTRUDA in the European Union

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. This approval is based on results from the pivotal Phase 3 KEYNOTE-204 trial, in which KEYTRUDA monotherapy demonstrated a significant improvement in progression-free survival (PFS) compared with brentuximab vedotin (BV), a commonly used treatment. KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88]; p=0.0027) and showed a median PFS of 13.2 months versus 8.3 months for patients treated with BV. The approval is also based on supportive data from an updated analysis of the KEYNOTE-087 trial; KEYNOTE-087 was the basis for the 2017 EC approval of KEYTRUDA for the treatment of adult patients with relapsed or refractory cHL who have failed ASCT and BV or who are transplant ineligible and have failed BV. This approval is the first pediatric approval for KEYTRUDA in the European Union (EU).

“The European Commission’s approval of an expanded use of KEYTRUDA provides another option for adult and pediatric patients with classical Hodgkin lymphoma who have disease progression after earlier lines of therapy or relapse after transplantation,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “We are driven to advance therapies to help improve outcomes for patients with blood cancers, including those with relapsed or refractory classical Hodgkin lymphoma, through our broad clinical program.”

This approval allows marketing of KEYTRUDA monotherapy in all 27 EU member states plus Iceland, Lichtenstein, Norway and Northern Ireland.

Merck is continuing to study KEYTRUDA across hematologic malignancies through a broad clinical program, including multiple registrational trials in cHL and primary mediastinal large B-cell lymphoma and more than 60 investigator-initiated studies across 15 tumors. In addition to KEYTRUDA, Merck is evaluating several clinical-stage assets for the treatment of patients with hematologic malignancies, including MK-1026 (formerly known as ARQ 531), a Bruton’s tyrosine kinase inhibitor, and MK-2140 (formerly known as VLS-101), an antibody-drug conjugate targeting ROR1.