Merck & Co.’s Keytruda has been a dominant force in the world of cancer treatment for over a decade, securing its 40th indication in June and continuing to add more approvals. Accounting for approximately 42% of the company’s sales in 2023, Keytruda faces the looming threat of biosimilar competition as early as 2028. To prepare for this patent cliff, Merck is bolstering its portfolio and diversifying its pipeline.
Dr. Joerg Koglin, Merck’s senior vice president and head of general medicine and global clinical development, emphasized the importance of broadening the company’s pipeline beyond Keytruda. He highlighted 2024 as a year of momentum and 2025 as a year with significant milestones, including study readouts and new filings.
One key focus for Merck is its cardiometabolic pipeline, which is projected to deliver seven potential approvals by 2030, with peak revenue potential exceeding $15 billion by the mid-2030s. The recent FDA approval of Winrevair, a breakthrough biologic for pulmonary arterial hypertension, has been a significant milestone. The broad label for Winrevair allows physicians to prescribe it to a wider range of patients, beyond those in the phase 3 study criteria.
Looking ahead, Merck aims to expand Winrevair’s label further, with ongoing studies in newly diagnosed PAH patients and heart failure patients with pulmonary hypertension. Additionally, the company is set to unveil its first pivotal study of an oral PCSK9 inhibitor for cholesterol management in 2025, offering a more accessible alternative to current injectable options.
While Merck’s late-stage pipeline is heavily focused on oncology, the company is also venturing into other emerging clinical areas such as immunology, neuroscience, and ophthalmology. Strategic acquisitions, including EyeBio, Prometheus Biosciences, and Caraway Therapeutics, have bolstered Merck’s presence in these areas. The recent global license deal with Hansoh Pharma for a preclinical oral GLP-1 receptor agonist signifies Merck’s interest in advancing oral therapies in the GLP-1 space.
Despite its continued focus on cancer treatments, Merck is excited about the expansion of its pipeline and the potential for new therapeutic options. With a strong emphasis on innovation and strategic partnerships, Merck is positioning itself for success beyond the era of Keytruda dominance. As Dr. Koglin noted, the company is on track with its pipeline development and remains optimistic about the future.
