Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new data for four approved medicines and three pipeline candidates in more than 15 types of cancer will be presented at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, from Oct. 20-24. Presentations will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA, Merck’s anti-PD-1 therapy; WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor; LENVIMA® (lenvatinib), in collaboration with Eisai; and LYNPARZA® (olaparib), in collaboration with AstraZeneca, and emphasize Merck’s commitment to improving outcomes for patients across multiple stages of cancer.
Additionally, new data from Merck’s diverse pipeline will be shared at the congress, including from MK-1084, a KRAS G12C inhibitor being evaluated as monotherapy and in combination with KEYTRUDA; from MK-2870 (also known as SKB264), an anti-TROP2 antibody drug conjugate (ADC) being developed in collaboration with Kelun-Biotech; and from V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT) being developed in collaboration with Moderna, in combination with KEYTRUDA.
“At ESMO 2023, we look forward to sharing new research highlighting the breadth of our portfolio and expanding pipeline, as we pursue breakthrough innovations in oncology to address critical gaps in care for patients in need,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “Our continued efforts to treat cancer earlier and make a meaningful impact are fueled by one goal: To give those who are counting on us more effective ways to treat their cancer.”
Key data from Merck’s portfolio to be presented at ESMO Congress 2023:
- First presentation of survival data from the Phase 3 KEYNOTE-A39/EV-302 trial evaluating KEYTRUDA plus enfortumab vedotin as a first-line treatment for patients with locally advanced or metastatic urothelial carcinoma (Presentation #LBA6,) which will be featured in an ESMO Presidential Symposium and as part of the ESMO Press Briefings;
- Presentation of overall survival (OS) results from the Phase 3 KEYNOTE-671 study evaluating KEYTRUDA in the perioperative setting (neoadjuvant KEYTRUDA plus chemotherapy followed by resection and adjuvant KEYTRUDA as a single agent) for resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) (Presentation #LBA56);
- First presentation of data from the Phase 3 KEYNOTE-A18 trial evaluating KEYTRUDA plus chemoradiotherapy in patients with high-risk, locally advanced cervical cancer (Presentation #LBA38);
- First presentation of data from the Phase 3 KEYNOTE-756 trial evaluating KEYTRUDA plus neoadjuvant chemotherapy and adjuvant endocrine therapy in early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer (Presentation #LBA21);
- First presentation of data from the Phase 3 LITESPARK-005 trial evaluating WELIREG for the treatment of patients with advanced renal cell carcinoma (aRCC) previously treated with immune checkpoint and anti-angiogenic therapies (Presentation #LBA88);
- First time presentation of progression-free survival (PFS) and OS data from the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA plus trastuzumab and chemotherapy as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma (Presentation #1511O);
- Updated 5-year event-free survival data from the Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment for patients with high-risk early-stage triple-negative breast cancer (TNBC) (Presentation #LBA18).
Key data from Merck’s pipeline to be presented at ESMO Congress 2023:
- First-time safety and preliminary efficacy data for MK-1084, a KRAS G12C inhibitor, as a monotherapy in solid tumors and in combination with KEYTRUDA in NSCLC (Presentation #663P);
- First presentation of data from a Phase 2 cohort of the Phase 1/2 trial evaluating MK-2870 (also known as SKB264) in previously treated metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (Presentation #380MO);
- Additional data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating V940 (mRNA-4157) in combination with KEYTRUDA as adjuvant treatment for high-risk melanoma (Presentation # LBA49).
Merck investor event
Merck will host an Oncology Investor Event to coincide with the ESMO Congress 2023 on Sunday, October 22, 2023, 7:00 p.m. CEST/1:00 p.m. ET, at which senior management will highlight key data presentations. The event will take place virtually and will be accessible via webcast. Investors, analysts, members of the media and the general public are invited to listen to a webcast of the presentation at: https://onlinexperiences.com/Launch/QReg/ShowUUID=9CC730AB-52D5-4ABB-8D7E-4A01DC92F832&LangLocaleID=1033
Details on abstracts listed above and additional key abstracts related to Merck’s portfolio and pipeline at ESMO Congress 2023:
| Breast cancer | |
| SKB264 (MK-2870) in previously treated hormone receptor-positive (HR+)/ HER2-negative metastatic breast cancer (mBC): Results from a phase I/II, single-arm, basket trial. Y. Yin. | Presentation #380MO, Mini oral session – Breast cancer, metastatic |
| Pembrolizumab or placebo plus chemotherapy followed by pembrolizumab or placebo for early-stage TNBC: Updated EFS results from the phase 3 KEYNOTE-522 study. P. Schmid. | Presentation # LBA18, Proffered Paper session – Breast cancer, early stage |
| KEYNOTE-756: Phase 3 study of neoadjuvant pembrolizumab (pembro) or placebo (pbo) + chemotherapy (chemo), followed by adjuvant pembro or pbo + endocrine therapy (ET) for early-stage high-risk ER+/HER2– breast cancer. F. Cardoso. (Led by Kelun-Biotech) | Presentation # LBA21, Proffered Paper session – Breast cancer, early stage |
| Gastrointestinal cancers | |
| Pembrolizumab versus chemotherapy in microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) metastatic colorectal cancer (mCRC): 5-year follow-up of the randomized phase 3 KEYNOTE-177 study. K. Shiu. | Presentation #LBA32, Mini oral session – Gastrointestinal tumours, lower digestive |
| Impact of baseline molecular alterations on the efficacy of tucatinib (TUC) plus trastuzumab (Tras) for HER2+, RAS WT metastatic CRC (mCRC) in MOUNTAINEER. J. Strickler. (Led by Seagen) | Presentation #551O, Proffered Paper session 1 – Gastrointestinal tumours, lower digestive |
| Pembrolizumab plus trastuzumab and chemotherapy for HER2+ metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Survival results from the phase 3, randomized, double-blind, placebo-controlled KEYNOTE-811 study. Y. Janjigian. | Presentation #1511O, Proffered Paper session 1 – Gastrointestinal tumours, upper digestive |
| Health-related quality of life (HRQoL) analysis from KEYNOTE-859: First-line (1L) pembrolizumab (pembro) + chemotherapy (chemo) for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. M. Lowery. | Presentation #1516P, Poster |
| Genitourinary cancers | |
| EV-302/KEYNOTE-A39: Open-label, randomized phase 3 study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC). T. Powles. | Presentation #LBA6, Presidential 2 |
| Phase 2 LITESPARK-003 study of belzutifan in combination with cabozantinib for advanced clear cell renal cell carcinoma (ccRCC). T. Choueiri. | Presentation #LBA87, Proffered Paper session 2 – Genitourinary tumours, non-prostate |
| Belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC): Randomized open-label phase 3 LITESPARK-005 study. L. Albiges. | Presentation #LBA88, Proffered Paper session 2 – Genitourinary tumours, non-prostate |
| Safety and efficacy of two doses of belzutifan in patients (pts) with advanced RCC: Results of the randomized phase 2 LITESPARK-013 study. N. Agarwal. | Presentation #1881O, Proffered Paper session 2 – Genitourinary tumours, non-prostate |
| Gynecologic cancers | |
| Pembrolizumab plus chemoradiotherapy for high-risk locally advanced cervical cancer: A randomized, double-blind, phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study. D. Lorusso. | Presentation #LBA38, Proffered Paper session 1 – Gynaecological cancers |
| Updated response data and analysis of progression free survival by mechanism of mismatch repair loss in endometrial cancer (EC) patients (pts) treated with pembrolizumab plus carboplatin/paclitaxel (CP) as compared to CP plus placebo (PBO) in the NRG GY018 trial. R. Eskander. | Presentation #LBA43, Mini oral session – Gynaecological cancers |
| Lung cancer | |
| Overall survival in the KEYNOTE-671 study of perioperative pembrolizumab for early-stage non-small-cell lung cancer (NSCLC). J. Spicer. | Presentation #LBA56, Proffered Paper session – Non-metastatic NSCLC and other thoracic malignancies |
| Safety and preliminary efficacy of the KRAS G12C inhibitor MK-1084 in solid tumors and in combination with pembrolizumab in NSCLC. C. Rojas. | Presentation #663P, Poster |
| Melanoma | |
| Pathologic response and exploratory analyses of neoadjuvant-adjuvant versus adjuvant pembrolizumab (PEM) for resectable stage IIIB-IV melanoma from SWOG S1801. S. Patel. | Presentation #LBA48, Proffered Paper session – Melanoma and other skin tumours |
| mRNA-4157 (V940) individualized neoantigen therapy + pembrolizumab vs pembrolizumab in high-risk resected melanoma: Clinical efficacy and correlates of response. J. Weber. | Presentation # LBA49, Proffered Paper session – Melanoma and other skin tumours |
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