On September 4, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that new data for four approved medicines and six pipeline candidates in more than 20 types of cancer will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain, from Sept. 13-17 (Press release, Merck & Co, SEP 4, 2024, View Source [SID1234646343]). Study findings from the Phase 3 KEYNOTE-522 trial (#LBA4) in high-risk early-stage triple-negative breast cancer (TNBC), the Phase 3 KEYNOTE-A18 trial (#709O) in high-risk locally advanced cervical cancer and the Phase 3 LEAP-012 trial (#LBA3) in unresectable, non-metastatic hepatocellular carcinoma, in collaboration with Eisai, have been selected for the ESMO (Free ESMO Whitepaper) Presidential Symposium Sessions. Data being shared at the Congress showcase the company’s continued progress in advancing clinical research for Merck’s broad portfolio and diverse pipeline of investigational candidates, with a total of 80 abstracts being presented.
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"Over the past decade, data on KEYTRUDA have contributed to paradigm shifts in the treatment of some of the deadliest forms of cancer and the rewriting of medical textbooks. We are very proud that today marks ten years since KEYTRUDA received its first approval in the U.S.," said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "The compelling data for KEYTRUDA at this year’s ESMO (Free ESMO Whitepaper) are demonstrative of KEYTRUDA’s impressive journey, from 10-year survival data in unresectable or metastatic melanoma to new overall survival data in earlier stages of two types of women’s cancers. We’re also excited to show how we’re building on our leadership in oncology with data from our broad and diverse pipeline as we work toward improved outcomes for as many patients as possible."
Presentations at the Congress will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy; WELIREG (belzutifan); LENVIMA (lenvatinib), in collaboration with Eisai; and LYNPARZA (olaparib), in collaboration with AstraZeneca.
Key data from Merck’s portfolio to be presented at ESMO (Free ESMO Whitepaper) Congress 2024:
First-time overall survival (OS) results from the Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment and then continuing as single agent as adjuvant treatment in patients with high-risk early-stage TNBC (Presentation #LBA4; Presidential Symposium II: Practice-changing trials).
OS data from the Phase 3 KEYNOTE-A18 trial evaluating KEYTRUDA in combination with concurrent chemoradiotherapy (CRT) as treatment for patients with high-risk locally advanced cervical cancer (Presentation #709O; Presidential Symposium I: Practice-changing trials).1
First presentation of results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating KEYTRUDA plus LENVIMA in combination with transarterial chemoembolization (TACE) in patients with unresectable, non-metastatic hepatocellular carcinoma (Presentation #LBA3; Presidential Symposium I: Practice-changing trials).2
Ten-year OS data from the Phase 3 KEYNOTE-006 trial evaluating KEYTRUDA compared to ipilimumab as first-line treatment for patients with advanced melanoma (Presentation #LBA44; Mini oral session: Melanoma and other skin tumours).
OS data from the per protocol final analysis of the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA plus trastuzumab and chemotherapy as first-line treatment for patients with advanced human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma (Presentation #1400O; Proffered paper session 2: GI tumours, upper digestive).
Data from the per protocol final analysis of the Phase 3 LITESPARK-005 trial evaluating WELIREG as treatment for adult patients with advanced renal cell carcinoma that progressed following PD-1/L1 inhibitor and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) therapies (Presentation #LBA74; Proffered paper session 1: GU tumours, non-prostate).
Additionally, new data on investigational candidates from Merck’s pipeline will be presented at the Congress, including for: patritumab deruxtecan (HER3-DXd), a HER3-directed antibody-drug conjugate (ADC), and ifinatamab deruxtecan (I-DXd; also known as MK-2400) being developed in collaboration with Daiichi Sankyo; sacituzumab tirumotecan (sac-TMT; also known as MK-2870/SKB264), an investigational anti-TROP2 ADC being developed in collaboration with Kelun-Biotech; and opevesostat (also known as MK-5684/ODM-208), an investigational steroid synthesis inhibitor in collaboration with Orion.
Key data on investigational candidates from Merck’s pipeline to be presented at ESMO (Free ESMO Whitepaper) Congress 2024:
Data from the Phase 2 ICARUS-BREAST01 trial evaluating HER3-DXd as treatment for patients with hormone-receptor (HR)-positive/HER2-negative advanced breast cancer (Presentation #340O; Proffered paper session: Breast cancer, metastatic).3
First-time data from a Phase 2 study conducted in China, independently led by Kelun-Biotech, evaluating sac-TMT as treatment for patients with previously treated advanced endometrial carcinoma and ovarian cancer (Presentation #715MO; Mini oral session 2: Gynaecological cancers).4
Findings from a Phase 2 study conducted in China, independently led by Kelun-Biotech, evaluating sac-TMT plus KEYTRUDA as treatment for patients with recurrent or metastatic cervical cancer (Presentation #716MO; Mini oral session 2: Gynaecological cancers).4
Details on abstracts listed above and additional key abstracts for Merck
Breast cancer
Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the Phase 3 KEYNOTE-522 study. P. Schmid.
Presentation #LBA4, Presidential Symposium II: Practice-changing trials
Efficacy, safety and biomarker analysis of ICARUS-BREAST01: a Phase 2 Study of Patritumab Deruxtecan (HER3-DXd), in patients (pts) with HR+/HER2- advanced breast cancer (ABC). B. Pistilli.3
Presentation #340O, Proffered paper session: Breast cancer, metastatic
Intensified alkylating chemotherapy with autologous stem cell rescue (IACT) or conventional chemotherapy followed by olaparib (CCT-O) in stage III, HER2-negative, homologous recombination deficient (HRD) breast cancer (BC): Survival results of the randomized-controlled SUBITO trial. S. Linn.5
Presentation #LBA14, Mini oral session: Breast cancer, early stage
Gastrointestinal cancers
Transarterial Chemoembolization (TACE) With or Without Lenvatinib (len) + Pembrolizumab (pembro) for Intermediate-Stage Hepatocellular Carcinoma (HCC): Phase 3 LEAP-012 Study. J. Llovet.2
Presentation #LBA3, Presidential Symposium I: Practice-changing trials
Final overall survival for the Phase 3, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma. S. Lonardi.
Presentation #1400O, Proffered paper session 2: GI tumours, upper digestive
Genitourinary cancers
Final analysis of the Phase 3 LITESPARK-005 study of belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC). B. I. Rini.
Presentation #LBA74, Proffered paper session 1: GU tumours, non-prostate
Opevesostat (MK-5684/ODM-208), an oral CYP11A1 inhibitor, in metastatic castration-resistant prostate cancer (mCRPC): updated CYPIDES Phase 2 results. K. Fizazi.6
Presentation #1605P, Poster
Alliance A031501: AMBASSADOR Study of Adjuvant Pembrolizumab (Pembro) in Muscle-Invasive Urothelial Carcinoma (MIUC) vs Observation (Obs): Extended follow-up disease-free survival (DFS) results and metastatic (met) disease recurrence distribution. A. B. Apolo.7
Presentation #1964MO, Mini oral session: GU tumours, non-prostate
Study EV-103 Dose Escalation/Cohort A (DE/A): 5y Follow-Up Of First-Line (1L) Enfortumab Vedotin (EV) + Pembrolizumab (P) in Cisplatin (cis)-Ineligible Locally Advanced Or Metastatic Urothelial Carcinoma (la/mUC). J. E. Rosenberg.8
Presentation #1968P, Poster
Preliminary Efficacy And Safety Of Disitamab Vedotin (DV) With Pembrolizumab (P) In Treatment (Tx)-Naive HER2-Expressing, Locally Advanced Or Metastatic Urothelial Carcinoma (la/mUC): RC48G001 Cohort C. M. D. Galsky.8
Presentation #1967MO, Mini oral session: GU tumours, non-prostate
Gynecologic cancers
Pembrolizumab plus chemoradiotherapy for high-risk locally advanced cervical cancer: Overall survival results from the randomized, double-blind, Phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study. D. Lorusso.1
Presentation #709O, Presidential Symposium I: Practice-changing trials
Safety and Efficacy of Sacituzumab Tirumotecan (sac-TMT) in Patients (pts) with Previously Treated Advanced Endometrial Carcinoma (EC) and Ovarian Cancer (OC) from a Phase 2 Study. D. Wang.4
Presentation #715MO, Mini oral session 2: Gynaecological cancers
Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT) Plus Pembrolizumab in Patients with Recurrent or Metastatic Cervical Cancer. X. Wu.4
Presentation #716MO, Mini oral session 2: Gynaecological cancers
Lung cancer
Neoadjuvant Pembrolizumab (pembro) or Placebo (pbo) Plus Chemotherapy and Adjuvant Pembro or Pbo for Early-Stage NSCLC: Subgroup Analyses of the Phase 3 KEYNOTE-671 Study. M. C. Garassino.
Presentation #1210P, Poster
Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with advanced solid tumors: Updated clinical and biomarker results from a phase I/II study. M. R. Patel. 3
Presentation #690P, Poster
Melanoma and other skin cancers
Pembrolizumab vs Ipilimumab in Advanced Melanoma: 10-Year Follow-Up of the Phase 3 KEYNOTE-006 Study. C. Robert
Presentation #LBA44, Mini oral session: Melanoma and other skin tumours
Pembrolizumab versus placebo after a complete resection of high-risk stage III melanoma: 7-year results of the EORTC 1325-MG/Keynote-054 double-blind Phase 3 trial. A. M. Eggermont.
Presentation #1095P, Poster
KEYMAKER-U02 substudy 02C: neoadjuvant pembrolizumab (pembro) and investigational agents followed by adjuvant pembro for stage IIIB-D melanoma. G. V. Long.
Presentation #1082O, Proffered paper session: Melanoma and other skin tumours
Pembrolizumab (pembro) vs placebo as adjuvant therapy for high-risk stage II melanoma: Long-term follow-up, rechallenge, and crossover in KEYNOTE-716. J. J. Luke.
Presentation #1078MO, Mini oral session: Melanoma and other skin tumours
KEYMAKER 02B: A randomized trial of pembrolizumab (pembro) alone or with investigational agents as first-line treatment for advanced melanoma. R. Dummer.
Presentation #1083P, Poster
Primary Results from TACTI-003: A Randomized Phase IIb Trial Comparing Eftilagimod Alpha (soluble LAG-3) Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with CPS ≥1. C. A. Kristensen.9
Presentation #LBA35, Proffered paper session: Head and neck cancer
1 In collaboration with the European Network for Gynaecological Oncology Trial (ENGOT) groups and the GOG Foundation, Inc. (GOG)
2 In collaboration with Eisai
3 In collaboration with Daiichi Sankyo
4 Independent study led by Kelun-Biotech
5 In collaboration with AstraZeneca
6 In collaboration with Orion Pharma
7 Sponsored by U.S. National Cancer Institute (NCI)/led by Alliance for Clinical Trials in Oncology
8 In collaboration with Astellas/Pfizer
9 In collaboration with Immutep