The Phase 3 clinical study investigating pembrolizumab (+) berahyaluronidase alfa (MK-3475A) for newly-diagnosed metastatic non-small cell lung cancer reached its primary completion on 2026-03-12. This trial, known as MK-3475A-F84, is evaluating a subcutaneous formulation of pembrolizumab compared to its intravenous administration.
Background
Pembrolizumab is an immunotherapy treatment used for various cancers, including metastatic non-small cell lung cancer (NSCLC). This study focuses on a formulation of pembrolizumab combined with berahyaluronidase alfa, designed for subcutaneous (SC) injection, as an alternative to the traditional intravenous (IV) infusion.
Trial design
The MK-3475A-F84 study (NCT06698042) is a Phase 3 clinical trial. It has an enrollment of 67 participants diagnosed with Lung Cancer and Non-Small Cell Lung Cancer. The trial is designed to compare the pharmacokinetics of pembrolizumab (+) berahyaluronidase alfa administered as a subcutaneous injection against pembrolizumab administered as an intravenous infusion.
What this means
The primary completion of this Phase 3 study signifies a key milestone in evaluating the subcutaneous formulation of pembrolizumab (+) berahyaluronidase alfa. If successful, a subcutaneous injection could offer a more convenient administration option for patients with metastatic non-small cell lung cancer compared to intravenous infusions, potentially improving patient experience and access to treatment.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT06698042, titled "A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)," was updated on 2026-03-12 on clinicaltrials.gov.