Phase 3 Trial Evaluates SC Pembrolizumab vs IV in NSCLC
Enriqueta Felip, MD, PhD, discusses the phase 3 3475A-D77 study of subcutaneous pembrolizumab plus chemotherapy in metastatic non–small cell lung cancer.
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 phase 3 3475A-D77 study (NCT05722015) of subcutaneous (SC) pembrolizumab compared with intravenous (IV) pembrolizumab, plus chemotherapy, for the treatment of patients with metastatic non–small cell lung cancer (NSCLC).1
“I was really pleased to present the results of the 3475A-D77 trial. In patients with lung cancer, the combination of chemotherapy plus pembrolizumab IV is standard of care for those patients without genomic alterations, and this is a randomized trial including patients with untreated stage IV non–small cell lung cancer and no alterations.”
The phase 3, open-label study randomly assigned patients in a 2:1 fashion to receive either pembrolizumab SC 790 mg every 6 weeks or pembrolizumab IV 400 mg every 6 weeks for 18 cycles, each given with platinum doublet chemotherapy.
Enrollment was open to patients 18 years of age and older with newly diagnosed stage IV squamous or nonsquamous NSCLC without sensitizing EGFR, ALK, or ROS1 alterations. Patients are required 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.2
“This is the study, and the rationale is to show that the combination of chemotherapy plus pembrolizumab SC is non inferior to the present standard of care that is chemotherapy plus pembrolizumab IV,” she adds.
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 March 25, 2025. Accessed April 3, 2025. https://clinicaltrials.gov/study/NCT05722015
