Merck & Co., Inc. (MRK - Free Report) announced that the FDA has granted priority review to yet another supplemental biologics license application (sBLA) for its PD-L1 inhibitor, Keytruda. In the latest sBLA, Merck is looking for FDA’s approval of Keytruda in combination with Pfizer’s (PFE - Free Report) Inlyta for the first-line treatment of advanced or metastatic renal cell carcinoma (RCC), the most common type of kidney cancer. With the FDA granting priority review, a decision is expected on Jun 20, 2019.
The sBLA filing is based on data from the pivotal phase III KEYNOTE-426 study as well as supporting data from an early stage study — KEYNOTE-035. Data from the KEYNOTE-426 study showed that the Keytruda+Inlyta combination led to significant improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as well as a key secondary endpoint of objective response rate (ORR) compared to Pfizer’s older kidney cancer treatment, Sutent.
Full data from the KEYNOTE-426 study was also presented at the 2019 Genitourinary Cancers Symposium as well as published in the New England Journal of Medicine. The additional data showed that the combination led to a 31% reduction in the risk of progression of disease or death (PFS) and a 47% reduction in the risk of death (OS). The ORR was 59.3% in the Keytruda+Inlyta combination arm while the same was 35.7% in the Sutent arm.
In the past year, Merck’s shares have outperformed the industry, rising 41.8% compared with a 5.9% increase for the industry.
This is the second priority review granted to Merck’s sBLA for Keytruda in less than a fortnight. Last week, Merck announced that the FDA has granted priority review to its sBLA looking for approval of Keytruda for the first-line treatment of patients with recurrent or metastatic head-and-neck squamous cell carcinoma (HNSCC), both as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy.
The sBLA was based on data from the phase III KEYNOTE-048 study wherein Keytruda as a monotherapy and in combination with chemotherapy, demonstrated significant improvement in OS compared to the standard of care in the given patient population whose tumors expressed PD-L1 with CPS (combined proportion score )≥20 and CPS≥1.
Keytruda is a key contributor to Merck’s sales growth. In a very short span of time, Keytruda has become Merck’s largest product. It is 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 first-line lung cancer indication as it is the only anti-PD-1 approved in first-line setting.
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 500 combination studies. Merck is collaborating with several companies including Amgen (AMGN - Free Report) , Incyte (INCY - Free Report) , Glaxo and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
We believe that Keytruda has strong future growth prospects based on increased utilization, approval for new indications and expectation of additional approvals worldwide
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
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