Additionally, pivotal Phase 3 data evaluating anti-PD-1 therapy KEYTRUDA as a first-line treatment in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) from the KEYNOTE-048 trial (Abstract #LBA8_PR) and the PARP inhibitor LYNPARZA (in collaboration with AstraZeneca) as maintenance therapy in newly diagnosed patients with BRCA-mutated (BRCAm) advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy from the SOLO-1 trial (Abstract #LBA7_PR) are to be presented in the ESMO Presidential Symposium and featured in the official ESMO Press Program.
“At Merck, our unwavering commitment to R&D has permitted us to establish an extraordinarily broad discovery research program in oncology,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “The data at ESMO are reflective of our focus on discovering important new targets and developing novel medicines – including KEYTRUDA and LYNPARZA – with the potential to set new treatment standards across multiple tumor types.”Key abstracts from Merck’s broad pipeline to be presented at ESMO include:
- First presentation of overall survival (OS) data from the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA for the first-line treatment of recurrent or metastatic HNSCC (Abstract #LBA8_PR).
- First-time findings from the Phase 2 KEYNOTE-057 trial evaluating KEYTRUDA monotherapy in the treatment of advanced non-muscle invasive bladder cancer (NMIBC) (Abstract 864O).
- First-time data from the pivotal Phase 3 SOLO-1 trial investigating LYNPARZA as maintenance therapy in newly diagnosed patients with BRCAm advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy (Abstract LBA7_PR). As previously announced, SOLO-1 met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo in these patients.
- First presentation of Phase 1 clinical data for MK-1454, Merck’s investigational stimulator of interferon genes (STING) agonist, as monotherapy and in combination with KEYTRUDA, for the treatment of patients with advanced solid tumors or lymphomas (Abstract #LBA15).
KEYTRUDA
- Abstract #LBA8_PR, Presidential Symposium: First-Line Pembrolizumab for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC): Interim Results From the Phase 3 KEYNOTE-048 Study. B. Burtness. Monday, October 22, 4:30-4:45 p.m. CEST. Location: Hall A2.
- Abstract #864O, Proffered Paper Session: Pembrolizumab for High-Risk (HR) Non–Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guérin (BCG): Phase 2 KEYNOTE-057 Trial. R de Wit, Saturday, October 20, 9:54-10:06 a.m. CEST. Location: Hall A1 – Room 17.
- Abstract #1244O, Proffered Paper Session: KEYNOTE-022 Part 3: Phase 2 Randomized Study of 1L Dabrafenib (D) and Trametinib (T) Plus Pembrolizumab (Pembro) or Placebo (PBO) for BRAF-Mutant Advanced Melanoma. P A Ascierto. Monday, October 22, 10:23-10:35 a.m. CEST. Location: ICM – Room 1.
- Abstract #LBA62, Poster Discussion Session: Health-related Quality of Life (HRQoL) for Pembrolizumab/Placebo plus Carboplatin and Paclitaxel/Nab-paclitaxel in Patients with Metastatic Squamous NSCLC: Data from KEYNOTE-407. J Mazieres. Sunday, October 21, Poster: 4:45-5:45 p.m. CEST. Discussion: 4:45-5:05 p.m. CEST. Location: ICM – Room 13.
- Abstract #LBA63, Poster Discussion Session: Long-term Survival in Patients (pts) with Advanced NSCLC in the KEYNOTE-010 Study Overall and in Pts who Completed 2 Years of Pembrolizumab (pembro). R S Herbst. Sunday, October 21, Poster: 4:45-5:45 p.m. CEST. Discussion: 4:45-5:05 p.m. CEST. Location: ICM – Room 13.
- Abstract #LBA36, Poster Discussion Session: Association of PD-L1 expression and Gene Expression Profiling with Clinical Response to Pembrolizumab in Patients with Advanced Recurrent Ovarian Cancer: Results from the Phase 2 KEYNOTE-100 Study. J A Ledermann. Saturday, October 20, Poster: 9:15-10:45 a.m. CEST. Discussion: 9:37-9:49 a.m. CEST. Location: ICM – Room 13.
- Abstract #LBA45, Poster Discussion Session: Phase 1b/2, Open Label, Multicenter, Study of the Combination of SD-101 and Pembrolizumab in Patients with Advanced Melanoma who are Naïve to Anti-PD-1 Therapy. G V Long. Saturday, October 20, Poster: 2:45-4:05 p.m. CEST. Discussion: 2:45-3:05 p.m. CEST. Location: ICM – Room 14b.
- Abstract #1248PD, Poster Discussion Session: Efficacy of Pembrolizumab (Pembro) in Patients (Pts) With Advanced Melanoma with Stable Brain Metastases (BM) at Baseline: A Pooled Retrospective Analysis O. Hamid. Saturday, October 20, Poster: 2:45-4:05 p.m. CEST. Discussion: 3:35 - 3:45 p.m. CEST. Location: ICM - Room 14b.
- Abstract #LBA7_PR, Presidential Symposium: Maintenance Olaparib Following Platinum-Based Chemotherapy in Newly Diagnosed Patients (pts) with Advanced Ovarian Cancer (OC) and a BRCA1/2 Mutation (BRCAm): Phase III SOLO1 Trial. K N Moore. Sunday, October 21, 5:45-6:00 p.m. CEST. Location: Hall A2 – Room 18
- Abstract #59PD, Proffered Paper Session: Final Analysis of Serum Biomarkers in Patients from the Phase 3 Study of Lenvatinib vs Sorafenib in Unresectable Hepatocellular Carcinoma [REFLECT]. R. Finn, Saturday, October 20, Poster: 15:00-16:00 CEST. Discussion: 15:30-16:00 CEST. Location: Hall B4 – Room 19.
- Abstract #1819O, Proffered Paper Session: Tumor Growth Rate and Lenvatinib Efficacy in Radioiodine-refractory Differentiated Thyroid Cancer. S. Leboulleux, Monday, October 22, 3:09-3:21 p.m. CEST. Location: Hall A1 – Room 16.
- Abstract #LBA15, Poster Discussion Session: Preliminary Results of the First-in-Human (FIH) Study of MK-1454, an Agonist of Stimulator of Interferon Genes (STING), Administered Intratumorally as Monotherapy or in Combination with Pembrolizumab (P) in Patients (pts) with Advanced Solid Tumors or Lymphomas. K J Harrington. Saturday, October 20, Poster: 3:00-4:15 p.m. CEST. Discussion: 3:00-3:20 p.m. CEST. Location: Hall B3 – Room 22.
- Abstract #LBA16, Poster Discussion Session: Phase 1/2, Multicenter, Open-Label Study of Intratumoral/Intralesional Administration of the Retinoic Acid–Inducible Gene I (RIG-I) Activator MK-4621 in Patients With Advanced or Recurrent Tumors. M R Middleton. Saturday, October 20, Poster: 3:00-4:15 p.m. CEST. Discussion: 3:00-3:20 p.m. CEST. Location: Hall B3 – Room 22.
- Abstract #LBA40, Poster Discussion Session: Phase 1b KEYNOTE-200. A Study of an Intravenously Delivered Oncolytic Virus, Coxsackievirus A21 in Combination with Pembrolizumab in Advanced NSCLC and Bladder Cancer Patients. C M Rudin. Saturday, October 20, Poster: 4:45-5:45 p.m. Discussion: 5:15-5:35 p.m. CEST. Location: ICM – Room 14b.
- Abstract #414PD, Poster Discussion Session: Phase 1 Study of the CTLA-4 Inhibitor MK-1308 in Combination With Pembrolizumab in Patients With Advanced Solid Tumors. B C Cho. Saturday, October 20, Poster: 3:00-4:15 p.m. CEST. Discussion: 3:30-3:45 p.m. CEST. Location: Hall B3 – Room 22.
Complete ESMO 2018 Conference Coverage