Merck Advances Oncology Innovation, Highlighting Progress in New Tumor Types and Earlier Stages of Disease at ESMO 2025

Positive survival data from KEYNOTE-905 and KEYNOTE-B96 to be featured in Presidential Symposium, underscoring the impact of KEYTRUDA^® (pembrolizumab) in certain bladder and ovarian cancers

Data from multiple investigational medicines from Merck’s innovative pipeline to be presented, including new results from REJOICE-Ovarian01 evaluating raludotatug deruxtecan (R-DXd) for certain patients with platinum-resistant ovarian cancer

Long-term data for KEYTRUDA in both earlier and metastatic non-small cell lung cancer support its foundational role in the treatment of this type of cancer

RAHWAY, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new research from more than 100 abstracts across more than 20 types of cancer and multiple treatment settings from the company’s broad and differentiated portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany, from Oct. 17-21. These data showcase Merck’s commitment to rapidly advancing research across multiple tumor types to help improve outcomes for patients across stages of cancer.

“Our data at ESMO this year affirm the continued impact and potential of KEYTRUDA in certain types of cancer and serve as a testament to the progress we’re making in our rapidly advancing pipeline with several notable presentations of data for our investigational antibody-drug conjugates,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “We are particularly proud that at this year’s ESMO, research evaluating our oncology medicines in certain bladder, ovarian and lung cancers was selected for discussion during three Presidential Symposium presentations.”

Presentations at the Congress will feature new or updated findings from Merck’s broad portfolio of cancer medicines, including data for KEYTRUDA^® (pembrolizumab); LENVIMA^® (lenvatinib), in collaboration with Eisai; WELIREG^® (belzutifan); and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph).

Key data being presented on existing medicines in Merck’s portfolio:

• First-time data from the Phase 3 KEYNOTE-905/EV-303 study evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus Padcev (enfortumab vedotin-ejfv) as a treatment for patients with cisplatin-ineligible muscle-invasive bladder cancer when given before and after surgery (Presentation #LBA2, Proffered paper session: Presidential Symposium I), which will be featured in an ESMO Presidential Symposium.¹
• First-time data from the Phase 3 KEYNOTE-B96 study evaluating KEYTRUDA in combination with chemotherapy (paclitaxel) with or without bevacizumab as a treatment for patients with platinum-resistant recurrent ovarian cancer (Presentation #LBA3, Proffered paper session: Presidential Symposium I), which will be featured in an ESMO Presidential Symposium.²
• Five-year exploratory follow-up data from the Phase 3 KEYNOTE-775/Study 309 trial evaluating KEYTRUDA plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, as a treatment for certain patients with advanced endometrial cancer (Presentation #1119P, Poster session: Gynaecological cancers).³
• Ten-year and eight-year exploratory follow-up data from multiple clinical trials evaluating KEYTRUDA monotherapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) (Presentation #3208P, Poster session: NSCLC, metastatic).
• Five-year exploratory follow-up results from the Phase 3 KEYNOTE-671 trial evaluating KEYTRUDA in the perioperative setting (neoadjuvant KEYTRUDA plus chemotherapy followed by resection and adjuvant KEYTRUDA as a single agent) for early-stage NSCLC (Presentation #LBA67, Mini oral session 2: Non-metastatic NSCLC).
• First presentation of results from cohort A1 of the Phase 2 LITESPARK-015 trial evaluating WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as a treatment for patients with advanced pheochromocytoma and paraganglioma (PPGL) (Presentation #1705O, Proffered paper session: NETs and endocrine tumours).
• Patient-reported preference outcomes from the Phase 2 MK-3475A-F11 trial evaluating patient preference for KEYTRUDA QLEX™ injection for subcutaneous use versus intravenous KEYTRUDA across multiple tumor types (Presentation #3145P, Poster session: General interest).

Additionally, new data for investigational antibody-drug conjugates (ADCs) from Merck’s innovative pipeline will be presented at the Congress, including data for raludotatug deruxtecan (R-DXd), a CDH6 directed DXd ADC, and ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, both discovered by Daiichi Sankyo. Notably, research evaluating sacituzumab tirumotecan (sac-TMT), a TROP2-directed ADC being developed in collaboration with Kelun-Biotech will be shared in four presentations in certain patients with lung, breast, cervical and prostate cancer.

Key data being presented on investigational candidates from Merck’s pipeline:

• Findings from the Phase 2 (dose optimization) part of the Phase 2/3 REJOICE-Ovarian01 trial evaluating R-DXd for patients with platinum-resistant, high-grade ovarian, primary peritoneal or fallopian tube cancer (Presentation #LBA42, Proffered paper session: Gynaecological cancers).⁴
• Results from the Phase 2 IDeate-Lung01 trial, led by Daiichi Sankyo, evaluating I-DXd for patients with pretreated extensive-stage small cell lung cancer and baseline brain metastases (Presentation #2760MO, Mini oral session 1: Non-metastatic NSCLC).⁴
• Data from the Phase 3 OptiTROP-Lung04 study evaluating sac-TMT as a treatment for patients with previously treated advanced EGFR-mutated NSCLC (Presentation #LBA5, Proffered paper session: Presidential Symposium II).⁵
• Primary results from the Phase 3 OptiTROP-Breast02 study evaluating sac-TMT as a treatment for patients with previously treated unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer (Presentation #LBA23, Proffered paper session 1: Breast cancer, metastatic).⁵
• Efficacy and safety data from the Phase 1/2 MK-2870-001 study evaluating sac-TMT for patients with advanced or metastatic cervical cancer (Presentation #1168P, Poster session: Gynaecological cancers).⁵
• Findings from cohort D of the Phase 2 MK-2870-002/SKB264-II-06 study evaluating sac-TMT plus KEYTRUDA for patients with metastatic castration-resistant prostate cancer (Presentation #2421P, Poster session: Prostate cancer).⁵

Details on presentations listed above and additional key presentations for Merck

About KEYTRUDA^® (pembrolizumab) injection, 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 1,600 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 KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use, 165 mg + 2,000 units/mL

KEYTRUDA QLEX is a fixed-combination drug product of pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody and berahyaluronidase alfa enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab. KEYTRUDA QLEX is administered as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel, over one minute every three weeks (2.4 mL) or over two minutes every six weeks (4.8 mL).

Selected KEYTRUDA^® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Indications in the U.S.

Melanoma

KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with unresectable or metastatic melanoma.

KEYTRUDA and KEYTRUDA QLEX are each indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with stage IIB, IIC, or III melanoma following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, for the first-line treatment of adult patients with metastatic squamous NSCLC.

KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the first-line treatment of adult patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

• stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
• metastatic.

KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the treatment of adult patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA or KEYTRUDA QLEX.

KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

Head and Neck Squamous Cell Cancer

KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.

KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with platinum and fluorouracil (FU), for the first-line treatment of adult patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the first-line treatment of adult patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Urothelial Cancer

KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma:

• who are not eligible for any platinum-containing chemotherapy, or
• who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the treatment of adult patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Cervical Cancer

KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with chemoradiotherapy (CRT), for the treatment of adult patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 III-IVA).

KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with or without bevacizumab, for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Merkel Cell Carcinoma

KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). For this indication, KEYTRUDA also is indicated for the treatment of pediatric patients, and KEYTRUDA QLEX also is indicated for the treatment of pediatric patients 12 years and older.

Renal Cell Carcinoma

KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with axitinib, for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with lenvatinib, for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

Kristen Drake

(908) 334-4688

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

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