June 8, 2026---RAHWAY, N.J. & FOSTER CITY, Calif.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Gilead Sciences, Inc. (Nasdaq: GILD) today announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 study investigating Gilead’s Trodelvy® (sacituzumab govitecan-hziy) in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, compared to KEYTRUDA monotherapy in certain patients with previously untreated metastatic non-small cell lung cancer, whose tumors expressed PD-L1 (tumor proportion score [TPS] ≥50%). The decision is based on the recommendation from the external Data Monitoring Committee (eDMC) following their review of the data from the pre-specified final analysis of progression-free survival (PFS) and interim analysis of overall survival (OS).
A numerical improvement in PFS was observed, but did not reach statistical significance. The probability of achieving statistically significant OS is unlikely at the planned final analysis. The safety profile of Trodelvy in combination with KEYTRUDA was consistent with the known safety of each agent. No new safety signals were identified with the combination. These data will be presented at a future medical meeting.
Regulatory authorities have been informed. Merck will inform study investigators of the recommendation from the DMC and advise patients in the study to speak to their physician regarding treatment. There are no changes to ongoing Trodelvy or Merck studies.
The companies are grateful to the patients, families, and healthcare professionals who participated in the KEYNOTE-D46/EVOKE-03 study and contributed to this important work.
Trodelvy is a registered trademark of Gilead Sciences, Inc., or its related companies.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Metastatic Non-Small Cell Lung Cancer
Lung cancer is one of the most common cancers worldwide, with an estimated 2.5 million new cases reported globally in 2022. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of lung cancers, and nearly half of these NSCLC patients are diagnosed only after the disease has spread, when treatment options are more limited and long-term survival remains low. Despite treatment advances, the 5-year survival rate for metastatic NSCLC is less than 10%. While immunotherapy, with or without chemotherapy, is a standard first treatment option, it does not work for everyone, and new treatment options are needed.
About KEYNOTE-D46/EVOKE-03
The KEYNOTE-D46/EVOKE-03 study is a global, open-label, randomized Phase 3 trial, sponsored by Merck, evaluating the efficacy and safety of Trodelvy (sacituzumab govitecan-hziy) in combination with KEYTRUDA (pembrolizumab) compared with KEYTRUDA monotherapy in patients with previously untreated metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 with a tumor proportion score (TPS) ≥50% and do not have sensitizing EGFR, ALK or ROS1 genomic alterations. Approximately 620 patients were enrolled across study sites worldwide.
Patients were randomized 1:1 to receive either Trodelvy (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) plus KEYTRUDA (200 mg intravenously on Day 1 of a 21-day cycle), or KEYTRUDA monotherapy (200 mg intravenously on Day 1 of a 21-day cycle). KEYTRUDA was administered for up to 35 cycles, and Trodelvy was continued until disease progression, death, unacceptable toxicity or another treatment discontinuation criterion was met.
The dual primary endpoints of the study are progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST v1.1, and overall survival (OS). Secondary endpoints include objective response rate (ORR), duration of response (DOR), patient-reported outcomes (PROs) and safety. More information about the study is available at ClinicalTrials.gov: NCT05609968.
About Trodelvy
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.
Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Healthcare professionals have well-established experience with Trodelvy, which has shown generally consistent outcomes across both clinical trials and real-world use in more than 75,000 breast cancer patients across 60+ countries.
Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in small cell lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.
About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
About Gilead and Kite Oncology
Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.