Sacituzumab govitecan-hziy

– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union – – ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS ≥10). The European Commission decision on this indication is anticipated later in 2026. Metastatic TNBC is an aggressive form of breast cancer that is associated with rapid disease progression and poor prognosis. Approximately 40% of metastatic TNBC tumors are PD-L1 positive. These tumors are considered more aggressive and associated with shorter survival, creating urgency to initiate treatment with effective regimens as soon as possible. For many living with metastatic TNBC, the most aggressive form of breast cancer, first-line therapy may be their only line of treatment. “People with metastatic triple-negative breast cancer need effective treatment options as early as possible in the course of their disease, particularly when their tumors express PD-L1,” said Evandro de Azambuja, MD, PhD, Head of the Medical Support Team, Jules Bordet Institute and Investigator of the ASCENT-04 study. “This positive opinion is welcome news for our patients and the entire clinical community. If authorized, Trodelvy plus Keytruda would build on the recent approval of Trodelvy monotherapy and help establish a Trodelvy-based approach as a first-line treatment option for patients with metastatic triple-negative breast cancer across PD-L1 status.” The CHMP’s recommendation is based on data from the Phase 3 ASCENT-04 study/KEYNOTE-D19 which demonstrated a highly statistically significant and clinically meaningful progression-free survival of Trodelvy plus Keytruda versus the combination of standard of care chemotherapy plus Keytruda as a first-line treatment in PD-L1 positive patients. In ASCENT-04/KEYNOTE-D19, Trodelvy plus Keytruda demonstrated a 35% reduced risk of disease progression or death in patients with PD-L1 positive metastatic TNBC. The ASCENT-04/KEYNOTE-D19 study utilized a patient-centered crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed. “Building on our established leadership in metastatic TNBC, this positive opinion reinforces our commitment to the breast cancer community,” said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. “People with metastatic TNBC desperately need new options as early as possible. This positive opinion, coupled with the recent EMA approval of Trodelvy monotherapy, is an important step in changing outcomes for these patients.” The European Commission has approved the use of Trodelvy as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. The U.S. Food and Drug Administration (FDA) has approved Trodelvy for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC. Trodelvy is approved for: either as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy or in combination with Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-mph) for patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. KEYTRUDA® and KEYTRUDA QLEX™ are trademarks of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC. 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. 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 globally approved for use in certain patients with metastatic TNBC and pre-treated HR+HER2- metastatic breast cancer. Healthcare professionals have substantial clinical experience with Trodelvy, with more than 75,000 breast cancer patients treated since 2020. It is the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer and the only Trop-2-directed ADC to demonstrate a meaningful overall survival benefit in two distinct types of metastatic breast cancer. Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression, including in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity. 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. 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. 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A pair of antibody-drug conjugate (ADC)-based breast cancer regimens are a step closer to European approval for some first-line indications.Gilead Sciences' Trodelvy (sacituzumab govitecan) secured its second first-line metastatic triple-negative breast cancer (TNBC) endorsement in Europe in the span of a month, with the EMA's Committee for Medicinal Products for Human Use (CHMP) recommending the TROP2-directed ADC together with Merck & Co.'s Keytruda (pembrolizumab) for patients whose tumours express PD-L1."If authorised, Trodelvy plus Keytruda would build on the recent approval of Trodelvy monotherapy and help establish a Trodelvy-based approach as a first-line treatment option for patients with metastatic triple-negative breast cancer across PD-L1 status," said Evandro de Azambuja, investigator of the Phase III ASCENT-04/KEYNOTE-D19 study backing the latest recommendation.EU regulators had approved Trodelvy as a single agent last month in the frontline setting for metastatic TNBC based on data from the Phase III ASCENT-03 study, where it showed a 38% reduced risk of disease progression or death in patients who aren't candidates for PD-(L)1 inhibitors.In ASCENT-04/KEYNOTE-D19, Trodelvy plus Keytruda demonstrated a 35% lower risk of disease progression or death in patients with PD-L1–positive metastatic TNBC. In more recent data presented at this year's American Society of Clinical Oncology (ASCO) meeting, the Trodelvy-Keytruda combo led to a 33% reduction in the risk of a progression-free survival 2 (PFS2) event versus Keytruda plus chemotherapy (see – KOL Views Q&A: Breast cancer at ASCO – first take on AZ and Roche oral SERD debates, Gilead's Trodelvy TNBC data and KOL Views Q&A: Gilead’s Trodelvy poised to redefine ADC sequencing in TNBC).A nod for EnhertuCHMP also adopted a positive opinion for AstraZeneca and Daiichi Sankyo's HER2-targeting ADC Enhertu (trastuzumab deruxtecan) in combination with Roche's Perjeta (pertuzumab) as a first-line treatment for HER2-positive metastatic breast cancer.The endorsement was backed by Phase III results from the DESTINY-Breast09 trial, where Enhertu-treated patients had a 44% lower risk of disease progression or death versus the current standard of taxane, Herceptin (trastuzumab) and Perjeta. Median PFS stood at 40.7 months for the doublet and 26.9 months for the comparator group.If approved, the regimen would become the first new first-line treatment option for HER2-positive metastatic breast cancer in the EU in more than a decade, according to AstraZeneca. The regimen was greenlit in this setting by the FDA late last year.