Merck & Co (MRK) American Society of Clinical Oncology Annual Meeting 2025 summary

Strategic vision and portfolio evolution

• Oncology diversification and expansion into new therapeutic areas such as HIV, vaccines, immunology, cardiovascular, and ophthalmology have been prioritized since 2021.

• KEYTRUDA has expanded from 26 to 41 indications since 2020, now spanning 18 tumor types and two tumor-agnostic indications, with over 3.4 million patients treated globally.

• The company aims to sustain oncology leadership beyond KEYTRUDA’s loss of exclusivity in 2028–2032 by leveraging a robust late-stage pipeline and innovative modalities.

• More than 60 phase III trials are ongoing across 16 candidates, with a focus on immuno-oncology, tissue targeting, ADCs, and precision targeting.

• Plans include 20 new launches over the next several years, 13 of which are in oncology.

Key clinical and pipeline highlights

• Subcutaneous pembrolizumab (pembro) with barohyaluronidase alfa demonstrated non-inferiority to IV KEYTRUDA in non-small cell lung cancer, with a median injection time of two minutes; regulatory reviews are ongoing.

• KEYNOTE-689 showed improved event-free survival in resectable head and neck cancer, marking the first advance in this population in over 20 years.

• MK-1084, an oral KRAS G12C inhibitor, showed a 77% response rate in PD-L1 positive non-small cell lung cancer when combined with pembrolizumab; phase III studies are ongoing.

• Zilovertamab vedotin (MK-2140) demonstrated mid-50% response rates in diffuse large B-cell lymphoma in combination with R-GemOx, outperforming historical controls.

• Sac-TMT (TROP2 ADC) showed significant efficacy in EGFR-mutated non-small cell lung cancer and triple-negative breast cancer, with global phase III studies underway.

Commercial and market strategy

• Oncology products are approved in 56 indications in the US, 44 in the EU, and 41 in Japan, with KEYTRUDA leading in approvals.

• Subcutaneous pembro is expected to reach 30–40% peak adoption in the US within 18–24 months post-launch, with initial uptake slowed by reimbursement processes.

• The late-stage pipeline represents a >$25 billion non-risk-adjusted commercial opportunity, with more than half driven by ADCs.

• The company is leveraging partnerships (e.g., Kelun-Biotech, Daiichi Sankyo) to advance ADCs and other novel assets globally.

• Pricing strategy for new formulations will focus on access, value, and market share, with competitive positioning against biosimilars and other entrants.