The demand for checkpoint inhibitors, especially those targeting PD-1 and PD-L1 has risen significantly in the past couple of years. Cancer therapies that target either PD-1 or PD-L1 can stop them from attaching and help keep cancer cells from hiding.
PD-L1 inhibitors available on the market are Merck ’s MRK Keytruda, AstraZeneca’s AZN Imfinzi, Bristol Myers’ BMY Opdivo, Roche’s Tecentriq and Pfizer’s PFE Bavencio.
Keytruda is a key contributor to Merck’s sales. In a very short span of time, Keytruda has become Merck’s biggest product. It is now already approved for use in 15 indications across 10 different tumor types in the United States. The drug generated sales of $7.17 billion in 2018, reflecting a massive 88% surge year over year.
Keytruda is continuously growing and expanding into new indications and markets globally. Keytruda sales are gaining particularly from strong momentum in the indication of first-line lung cancer as it is the only anti-PD-1 approved in the first-line setting in certain patients both as a monotherapy as well as combination therapy.
The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 900 studies, including more than 600 combination studies. Merck is collaborating with several companies including Amgen, Incyte, Glaxo and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
A key recent FDA approval was for first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC) – a difficult-to-treat lung cancer patient population - in October last year based on data from the KEYNOTE-407 study. Following this approval, Keytruda witnessed strong uptake in this patient population in the United States in the fourth quarter. Last week, European Commission granted marketing approval to Keytruda for the same indication which can drive sales higher in 2019.
In fact, in 2019 so far, Merck has announced several positive pipeline updates related to Keytruda. This included FDA approval as an adjuvant therapy for high-risk stage III melanoma, Committee for Medicinal Products for Human Use (CHMP) nod for an improved six-week dosing schedule, FDA’s priority review for Keytruda+Pfizer’s Inlyta for first-line advanced/metastatic renal cell carcinoma (RCC) as well as first-line recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) and five new label expansion approvals in Japan.
Several regulatory decisions for new indications in the United States as well as in Europe are pending in 2019, which if approved can further boost sales.
Though Keytruda has its share of side effects and suffered some major pipeline setbacks, we believe that Keytruda has strong growth prospects based on increased utilization, recent approvals for new indications and potential additional approvals worldwide.
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