Merck Q1: Keytruda sales up 23%

Merck’s Q1 sales were $15.bn, an increase of 50% from Q1 2021, the company reported this morning.

Sales of the monoclonal antibody Keytruda grew 23% to $4.7bn, with the drug gaining approvals for multiple indications around the world (excluding the impact from foreign exchange, sales grew 27%).

Meanwhile, COVID-19 antiviral treatment Lagevrio (molnupiravir) totaled $3.2bn in the quarter, primarily from sales in the US, UK, Japan and Australia (the drug was first authorized in November 2021).

Growth in vaccines in Q1 was primarily driven by HPV vaccines Gardasil and Gardasil 9. Sales grew 59% to $1.5bn, primarily driven by strong demand outside of the US, particularly in China, which also benefited from increased supply. Earlier this month, Merck announced an expansion to its Elkton, VA, manufacturing facility​​: increasing capacity as part of a pledge to double supply of HPV vaccines from 2020-2023.

Keytruda developments

Since receiving its first approval in 2014, Merck's blockbuster drug Keytruda (pembrolizumab) continues its growth trajectory: seeing 20% sales growth in FY2021 to $17.2bn.

Global sales growth of Keytruda reflects continued strong momentum from the non-small cell lung cancer (NSCLC) indications as well as uptake in other indications, including radically unresectable or metastatic renal cell carcinoma (RCC), head and neck squamous cell carcinoma, locally advanced, or early-stage triple-negative breast cancer (TNBC) and  advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) cancers. 

Keytruda’s regulatory highlights over the quarter have included:

• FDA approval​ of Keytruda, an anti-PD-1 therapy, as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation, based on data from Cohorts D and K of the KEYNOTE-158 trial.
• Japan’s Ministry of Health, Labour and Welfare approval​ of Keytruda plus Lenvima (lenvatinib), an orally available tyrosine kinase inhibitor being co-developed and co-commercialized with Eisai, for radically unresectable or metastatic renal cell carcinoma (RCC) based on results from the CLEAR/KEYNOTE-581 study.
• Positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for a recommendation​ for Keytruda in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent or metastatic cervical cancer in adult patients whose tumors express PD-L1 (Combined Positive Score ≥1) (KEYNOTE-826); and a recommendation​ for Keytruda as a monotherapy for certain patients with unresectable or metastatic MSI-H/dMMR colorectal, gastric, small intestine or biliary cancer, as well as advanced or recurrent MSI-H/dMMR endometrial cancer (KEYNOTE-158/KEYNOTE-164); and a recommendation​ for Keytruda in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced, or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence (KEYNOTE-522).

In studies, updates include:

• Results​ from the KEYNOTE-091 trial (EORTC-1416-LCG/ETOP-8-15 – PEARLS): in which the study found that adjuvant treatment with Keytruda significantly improved disease-free survival (DFS), one of the dual primary endpoints, compared to placebo in patients with stage IB to IIIA non-small cell lung cancer (NSCLC) following surgical resection, regardless of PD-L1 expression. There was also an improvement in DFS for patients whose tumors express PD-L1 (Tumor Proportion Score ≥50%) treated with Keytruda compared to placebo, the other dual primary endpoint; these results did not reach statistical significance per the pre-specified statistical plan.
• Positive topline distant metastasis-free survival results​ for the KEYNOTE-716 trial evaluating Keytruda for the adjuvant treatment of patients with resected stage IIB and IIC melanoma compared to placebo. These key secondary endpoint results build on the FDA approval and previously reported statistically significant improvement observed in recurrence-free survival.