Business Decision

The primary objective is to estimate the efficacy of experimental treatment with the anti-PD-1 antibody cemiplimab (REGN2810) in combination with simultaneous or subsequent radiotherapy (RT) in early-stage favorable classical Hodgkin lymphoma (cHL).

Secondary objectives are to assess the safety and feasibility of the 2 experimental strategies.

Key Inclusion Criteria:

• Histologically proven classical HL
• First diagnosis, no previous treatment
• Stage I-II without risk factors as defined in the protocol

Key Exclusion Criteria:

• Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)
• Prior malignancy within the previous 5 years (except for locally treatable cancers that have been apparently cured by complete resection)
• Prior chemotherapy or radiation therapy
• Concurrent disease precluding protocol treatment as defined in the protocol
• Pregnancy or breast-feeding
• Non-compliance as defined in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.

Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).