Keytruda keeps on climbing for Merck as other PD-1s flounder
- While Merck & Co's second quarter sales rose only 1% to $9.9 billion, the quarter was marked by 180% increase in sales for its checkpoint inhibitor Keytruda (pembrolizumab). Sales of the closely watched drug climbed to $881 million, Merck said Friday morning.
- But the company made headlines Thursday when it announced an oncology collaboration with AstraZeneca that will give it co-development and co-commercialization rights to the British pharma's PARP inhibitor Lynparza (olaparib).
- A June 2017 cyber-attack disrupted Merck's worldwide operations, including manufacturing, research and sales operations, and work is still ongoing to re-establish packaging, formulation and active pharmaceutical ingredient operations. Clinical trials remain on plan.
The key indication for Keytruda is currently non-small cell lung cancer (NSCLC), as Keytruda is the only PD-1 inhibitor approved for first line treatment of this indication. During the second quarter, the drug had three accelerated approvals and one full approval in the U.S., as well as an approval and a recommendation in the EU. Keytruda is also now included in the National Comprehensive Cancer Network guidelines.
"We are continuing to build our leadership position in immuno-oncology," said Ken Frazier, chairman and CEO of Merck, in the Friday morning conference call. "Lung cancer now makes up half of our Keytruda sales in the U.S., and it is becoming standard of care for this indication. We have first or second-line approval for lung cancer in over 60 countries, and we are increasingly seeing people tested for their PD-1 status."
The primary lung cancer market is a very competitive environment, and there are a lot of results emerging in combination therapies in lung cancer. While Merck has had success in the indication, competitors like Bristol-Myers Squibb and now AstraZeneca have had high-profile failures in the patient population. Lung cancer has long been considered the holy grail for these drugs due to the large patient population.
One of the accelerated approvals this quarter was for the combination of Keytruda, Eli Lilly's Alimta (pemetrexed) and carboplatin. The KEYNOTE 189 study will be used to support the approval.
"KEYNOTE-189 is an event-driven study and so we can't be definite on timing, but our current estimate is that we will release topline results this year," said Roger Perlmutter, EVP and president of Merck Research Laboratories.
One of Keytruda's accelerated approvals is for the treatment of previously treated patients with advanced microsatellite instability-high cancers.
"We are starting to see interest in this indication — it's our first tumor-agnostic approval for Keytruda," said Frazier. "This is a landmark in personalized medicine."
There were challenges, however. The pivotal Phase 3 KEYNOTE-040 trial in recurrent or metastatic head and neck squamous cell carcinoma did not meet its primary endpoint, and the Food and Drug Administration put a full clinical hold on two multiple myeloma clinical trials, and a partial hold on a third.
"We will make a detailed examination of the head and neck squamous cell carcinoma results, and will present these at a scientific meeting," said Perlmutter.
Despite all the advances for Keytruda, the largest step forward will likely be its pairing with AstraZeneca's Lynparza.
"The deal with AstraZeneca reflects the alignment between the two companies," said Perlmutter. "Data from Lynparza in ovarian cancer are already exciting. There are 10 ongoing regulatory trials in 14 different tumor types. We think that this combination may be less about the tumor type and more about the histology of the tumor, so another step towards personalized medicine," said Perlmutter.
Editor's note: A previous version of this article incorrectly stated the June 2017 cyber-attack led Merck to reduce its estimated range for full-year GAAP earnings per share. The lowering of Merck's full-year EPS estimate was due to licensing expenses related to the oncology partnership Merck announced July 27 with AstraZeneca.
- Merck & Co. Statement
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