Sotatercept

MSD’s Keytruda initially gained approval in Canada in 2015. Credit: JHVEPhoto/Shutterstock. Health Canada has approved MSD’s anti-programmed cell death protein 1 (PD-1) therapy Keytruda for treating adults with resectable stage II, IIIA or IIIB non-small cell lung carcinoma (NSCLC) in combination with platinum-containing chemotherapy. It is intended for use as a neoadjuvant treatment, followed by continued monotherapy as adjuvant treatment post-surgery. The decision by Health Canada is underpinned by the multicentre, double-blind Phase III KEYNOTE-671 trial outcomes, which showed a “statistically significant” improvement in event-free survival and overall survival when compared to the placebo plus chemotherapy regimen followed by only adjuvant placebo. MSD Canada oncology business unit vice-president and executive director André Galarneau stated: “Today, we’ve made a significant step forward with the approval of the first anti-PD-1 therapy in Canada for the perioperative treatment of resectable non-small cell lung cancer. “This approval highlights our commitment to expanding treatment options for lung cancer patients. We’re excited to continue this progress and collaborate with community partners to help patients affected by this disease.” The randomised placebo-controlled trial evaluated the therapy in combination with chemotherapy, followed by surgery and adjuvant monotherapy. Eligible subjects for this trial included those with previously untreated and resectable Stage II, IIIA or IIIB (N2) NSCLC, as determined by the eighth edition of the American Joint Committee on Cancer. The trial did not select subjects based on tumour PD-L1 expression levels. However, those with certain medical conditions, such as active autoimmune disease requiring systemic therapy within two years of treatment, or a history of interstitial lung disease/pneumonitis requiring steroid treatment, were excluded. Keytruda functions by enhancing the immune system’s ability to identify and combat tumour cells. It first gained approval in Canada in 2015. MSD previously received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for sotatercept, branded as Winrevair, for the treatment of pulmonary arterial hypertension in adults.

On February 4, Merck & Co. announced its 2024 financial results, revealing total revenue of $64.168 billion, marking a 7% increase year-on-year. The pharmaceutical segment alone generated $57.400 billion, also reflecting a 7% growth. However, research and development (R&D) spending dropped significantly to $17.938 billion, a decline of 41%. In a concerning trend, revenue from the Chinese market fell by 20% to $5.394 billion, representing 9.4% of Merck's global pharmaceutical sales. Despite these challenges, Merck's flagship product, Keytruda (pembrolizumab), set new sales records, achieving $29.482 billion in revenue, an 18% increase that accounted for nearly 46% of the company’s total revenue. As Keytruda continues to thrive, Merck is actively working to maximize its clinical and commercial value. This includes expanding early indications, exploring combination therapies, and developing a subcutaneous formulation. In November 2024, the subcutaneous formulation's Phase III study was successfully completed, reducing administration time to just 2-3 minutes compared to intravenous infusion. Other oncology products also performed well, with the world’s first HIF-2α inhibitor, Welireg, generating $509 million in sales, up 133% year-on-year. This drug received approval in China in November 2024. Additionally, Lynparza (olaparib) contributed $1.311 billion to the revenue. Merck's HPV vaccine, Gardasil/Gardasil 9, reported sales of $8.583 billion, a 3% decrease from the previous year. The decline was largely attributed to reduced demand in China, exacerbated by intense competition from domestic nine-valent vaccines and price wars involving two-valent HPV vaccines. In response, Merck has begun targeting the male market for HPV vaccination. In January 2025, Gardasil was approved in China for use in males aged 9-26, marking it as the first HPV vaccine approved for this demographic. Merck has also been proactive in updating its vaccine portfolio. In June 2024, it launched the 21-valent pneumococcal conjugate vaccine, Capvaxive, enhancing its product lineup alongside Pneumovax 23 and Vaxneuvance. In the cardiovascular sector, the new pulmonary arterial hypertension (PAH) drug Winrevair has emerged as a star product. Approved in March 2024, it has quickly generated $419 million in sales within its first year. The drug has also been submitted for approval in China. Looking ahead, Merck is optimistic about its pipeline, which includes oral PCSK9 inhibitors and dual agonists for GLP-1R/GCGR expected to yield critical research data in 2025. The company is also ramping up efforts in infectious diseases and ophthalmology, with Clesrovimab submitted for U.S. approval as a single-dose RSV monoclonal antibody. Merck's business development activities have intensified, particularly in China, with several strategic acquisitions aimed at expanding its innovative capabilities. These include a $700 million acquisition of CD3/CD19 bispecific antibodies and a $588 million agreement for a PD-1/VEGF bispecific antibody project. Robert M. Davis, Merck’s Chairman and CEO, expressed confidence in the company’s long-term growth potential, stating, “Our strong growth in 2024 reflects the market demand for our innovative product portfolio, including Keytruda, Winrevair, and our robust animal health business.” Looking forward to 2025, Merck anticipates global sales between $64 billion and $65.6 billion.