Welcome to Merck’s First Quarter 2023 conference call. Peter Dannenbaum, Vice President, Investor Relations. I would now like to turn the call over to Mr. At this time, all participants are in a listen-only mode until the question-and-answer session of today’s conference. Welcome to the Merck and Company Q1 Sales and Earnings Conference Call. Trung Huynh - Credit Suisse - Analyst Presentation: Malcolm Hoffman - BMO Capital Markets - Analystĭaina Graybosch - SVB Securities - Analyst Li, M.D., Ph.D. - Executive Vice President and President, Merck Research Laboratories Analysts:Ĭhris Shibutani - Goldman Sachs - Analyst Davis - Chairman and Chief Executive OfficerĬaroline Litchfield - Executive Vice President and Chief Financial Officerĭean Y. Peter Dannenbaum - Vice President, Investor Relations (NYSE: MRK) Q1 2023 Earnings Call dated Apr. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.Merck & Co., Inc. The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. The study authors’ full disclosures can be found at. Hyun Cheol Chung, MD, PhD, of the Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, is the corresponding author for the Journal of Clinical Oncology article.ĭisclosure: The study was supported by Merck Sharp & Dohme, a subsidiary of Merck & Co. Food and Drug Administration granted accelerated approval of pembrolizumab for patients with advanced PD-L1–positive cervical cancer who experienced progression during or after chemotherapy.” The investigators concluded, “Pembrolizumab monotherapy demonstrated durable antitumor activity and manageable safety in patients with advanced cervical cancer. No treatment-related deaths were reported. The most common immune-mediated adverse events of any grade were hypothyroidism (11.2%) and hyperthyroidism (9.2%). Immune-mediated adverse events occurred in 25.5% of patients, with grade 3 or 4 events occurring in 5.1% (hepatitis in 2 patients, severe skin reaction in 2 patients, and adrenal insufficiency in 1 patient). Treatment-related adverse events led to discontinuation of treatment in 4 patients (4.1%). Treatment-related grade 3 or 4 adverse events occurred in 12.2% of patients, with the most common being increased alanine transaminase (3.1%). Treatment-related adverse events of any grade occurred in 65.3% of patients, with the most common being hypothyroidism (10.2%), decreased appetite (9.2%), and fatigue (9.2%). Median overall survival was 9.4 in the total population vs 11.0 months in the PD-L1–positive population. Median progression-free survival was 2.1 months in both the entire population and the PD-L1–positive population. Median duration of response was not reached (range = ≥ 3.7 to ≥ 18.6 months), with response in 7 patients lasting ≥ 12 months at time of analysis. In the PD-L1–positive group, median time to response was 2.1 months. All responses occurred among the 82 patients with PD-L1–positive tumors (response rate = 14.6%), and 11 responses occurred among the 77 of these patients (14.3%) who had received ≥ 1 line of chemotherapy for recurrent or metastatic disease. Objective response was observed in 12 patients (12.2%), including 3 with complete response. Eighty-two patients (83.7%) had PD-L1–positive tumors (combined positive score ≥ 1), and 77 in the PD-L1–positive group had previously received ≥ 1 line of chemotherapy for recurrent or metastatic disease. Patients had a median age of 46 years (range = 24–75 years). The primary endpoint was objective response rate on RECIST v1.1 assessed by independent central radiologic review. Tumor imaging was performed every 9 weeks for the first 12 months, and then every 12 weeks thereafter. These patients received pembrolizumab 200 mg every 3 weeks for 2 years or until progression, intolerable toxicity, or physician or patient decision. The current report is an interim report on the cohort of 98 patients with previously treated advanced cervical cancer. KEYNOTE-158 is a basket trial in multiple cancer types. The study supported the 2018 accelerated approval of pembrolizumab in this setting.
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