Merck & Co., Inc. (MRK) Citi 18th Annual BioPharma Conference (Transcript)

Summary of Merck & Co., Inc. Conference Call Company Overview - Company: Merck & Co., Inc. (NYSE:MRK) - Event: Citi 18th Annual BioPharma Conference - Date: September 6, 2023 - Participants: Marjorie Green (SVP and Head of Late Stage Oncology, Global Clinical Development), Andrew Baum (Citi) Key Points Industry Focus - Oncology Development: Discussion centered around Merck's oncology pipeline, particularly the development of anti-TIGIT therapies and their combination with KEYTRUDA. Core Insights 1. TIGIT Development: Merck emphasizes overall survival (OS) as the key endpoint for TIGIT studies, rather than progression-free survival (PFS), due to the modest efficacy improvements in PFS not always translating to OS [3][14] 2. G5003 Study: The G5003 study is designed to test the efficacy of anti-TIGIT co-formulation compared to KEYTRUDA, with an increased sample size to focus on patients with high PD-L1 expression [5][6] 3. Chemotherapy Combination Trials: Merck is conducting trials combining chemotherapy with PD-1 inhibitors, with ongoing debates about the role of immunogenic cell death in enhancing efficacy [10][11] 4. Antigen Presentation: The company believes that increased antigen presentation can occur without immunogenic cell death, suggesting that efficacy can still be achieved across a range of PD-L1 expressions [11][12] 5. ADC Development: Merck is exploring antibody-drug conjugates (ADCs) and their potential in various cancers, acknowledging the challenges in biomarker-dependent efficacy [19][21] 6. HER2 Targeting: Discussion on the potential of targeting HER2 low expression in solid tumors, with a focus on the challenges of demonstrating efficacy in this area [28][29] 7. Nemtibrutinib and IRA Impact: The Inflation Reduction Act (IRA) is influencing drug development strategies, but Merck remains committed to developing nemtibrutinib, which may help prevent resistance to BTK inhibitors [46] 8. Early Stage Cancer Focus: Merck is committed to improving cure rates in early-stage cancers, with ongoing studies and a focus on innovative therapies [59][60] Additional Insights - Regulatory Relationships: Merck has established good relationships with regulators, which may facilitate the advancement of their mRNA technology and other therapies [36][38] - Clinical Trial Design: The company is cautious about trial designs and outcomes, particularly in the context of competitive landscapes and emerging data [52][56] - Investment in Discovery: Merck is investing in its internal discovery capabilities while also pursuing external partnerships and acquisitions to enhance its oncology portfolio [48] Potential Risks - Market Competition: The crowded field of KRAS inhibitors and ADCs presents challenges for differentiation and market positioning [52][56] - Regulatory Challenges: Ongoing changes in healthcare policy, such as the IRA, may impact the development timelines and financial viability of new therapies [46] Conclusion Merck is actively advancing its oncology pipeline with a focus on innovative therapies, particularly in the areas of anti-TIGIT and ADCs. The company is navigating a complex regulatory environment while maintaining a commitment to improving patient outcomes in cancer treatment.