Merck gets high with subcutaneous Keytruda
A week after Merck toplined a pivotal win with subcutaneous Keytruda, more details have emerged about an upcoming phase 3 study in high PD-L1 expressers. A clinicaltrials.gov entry is now available for the Keynote-F84 trial, which is set to enrol first-line NSCLC patients with PD-L1 levels of 50% or higher; Keynote-D77, which prevailed last week, also in first-line NSCLC, makes no mention of PD-L1 expression. With Keynote-D77 hitting in a presumably all-comers population, it’s unclear why Merck also needs to carry out Keynote-F84; perhaps things will become clearer when full results of the former are presented, likely next year. It’s also unclear whether Keynote-F84, which will test SC Keytruda versus the approved intravenous formulation and is set to start by the end of this month, will include any US patients: sites are currently listed in China, South Korea, Poland and Romania. Keynote-D77 was designed to support the filing of SC Keytruda (also known as MK-3475A) in all intravenous Keytruda’s solid tumour indications; Merck is also carrying out Keynote-F65 to support haematological cancer uses, and a patient preference trial is due to complete next year.
Phase 2 & 3 trials of subcutaneous Keytruda
| Trial | Setting | Note |
|---|---|---|
| Ph2 Keynote-F11 (MK-3475A-F11) | Patient preference study (multiple tumour types) | Completes Mar 2025 |
| Ph2 Keynote-E39 (MK-3475A-E39) | Cutaneous squamous cell carcinoma (Japan only) | Completes Mar 2027 |
| Ph2 Keynote-F65 (MK-3475A-F65) | r/r lymphoma | Started Oct 2024; to support US filing in haematological cancer indications |
| Ph3 Keynote-D77 (MK-3475A-D77) | 1st-line NSCLC (all comers) | Toplined positive Nov 2024; to support US filing in solid tumour indications |
| Ph3 Keynote-F84 (MK-3475A-F84) | 1st-line NSCLC (PD-L1 ≥50%) | To start Nov 2024 |
Source: OncologyPipeline & clinicaltrials.gov.
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