Behind the Phase 3 3475A-D77 Trial of SC Pembrolizumab in NSCLC
Enriqueta Felip, MD, PhD, discusses the design of the phase 3 3475A-D77 trial evaluating subcutaneous pembrolizumab in metastatic NSCLC.
Enriqueta Felip, MD, PhD, the Universitat Autònoma de Barcelona, Spain, section chief at the Vall d'Hebron University Hospital, head of the Vall d' Hebron Institute of Oncology's thoracic tumors group, discusses the design of the phase 3 3475A-D77 trial (NCT05722015) evaluating subcutaneous (SC) pembrolizumab vs intravenous (IV) pembrolizumab, plus chemotherapy, for the treatment of patients with metastatic non–small cell lung cancer (NSCLC).1
Felip explains that in this open-label, phase 3 study, investigators randomly assigned patients in a 2:1 fashion to receive either treatment with SC pembrolizumab at a dose of 790 mg every 6 weeks or IV pembrolizumab at a dose of 400 mg every 6 weeks for 18 cycles. Each arm was also treated with platinum doublet chemotherapy.2
The study enrolled patients aged 18 years and older who had newly diagnosed stage IV squamous or nonsquamous NSCLC without sensitizing EGFR, ALK, or ROS1 alterations. Additional enrollment criteria required patients to provide an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated and must have a life expectancy of at least 3 months.
The primary end points were area under the curve of pembrolizumab measured after the first dose and trough concentration of pembrolizumab measured at steady state.
“There are other secondary end points that we have analyzed, also a response rate in both treatment arms, PFS, duration of response, and also safety,” adds Felip.
References:
Felip E, Rojas CI, Schenker M, et al. Subcutaneous Versus Intravenous Pembrolizumab, in Combination With Chemotherapy, for Treatment of Metastatic Non-Small Cell Lung Cancer: The Phase 3 3475A-D77 Trial. Ann Oncol. Published online March 25, 2025. doi:10.1016/j.annonc.2025.03.012
A study of subcutaneous (SC) pembrolizumab coformulated with berahyaluronidase alfa (MK-3475A) vs intravenous pembrolizumab in adult participants with metastatic non-small cell lung cancer (NSCLC) (MK-3475A-D77). ClinicalTrials.gov. Updated January 31, 2025. Accessed April 14, 2025. https://clinicaltrials.gov/study/NCT05722015
