- After a first-line approval in lung cancer for Keytruda, Merck is shifting focus to combination therapies, with Keytruda currently in over 200 combo studies and chemo-combo data expected in September 2017.
- In other strategy news, mergers and acquisitions are top of mind for the company. Frazier said that looking at ways to augment the company's pipeline remains an important priority, and the company is open to deals of all kinds.
- Pharmaceutical total sales were $9.4 billion in the third quarter, a 6% increase on the third quarter in 2015, driven largely by the 124% increase in Keytruda sales, as well as increases in vaccines, cardiovascular therapeutics and hospital acute care.
The nine month earnings call held Tuesday morning reflected the company's excitement about Keytruda. Monday saw an approval from the Food and Drug Administration for first-line treatment of non-small cell lung cancer (NSCLC) in people with PD-L1 expression levels of 50% or higher, making it the first PD-1 inhibitor for the patient population. Keytruda has also got a label update, expanding the patient population for second-line lung cancer as well.
"This approval has significant implications for lung cancer, and it is the first time in decades that we might see a change in the standard of care for this disease," said CEO Ken Frazier on the call. "This is a proof-of-concept of our innovation strategy, and we will continue to follow the science."
Around 250,000 people are newly diagnosed with lung cancer each year in the U.S., Japan and Europe, and Merck could potentially capture 25% to 30% of this market. The company said it already has a 10% share of second-line patients.
And it's not just lung cancer in recent Keytruda news – the company was also celebrating approval in recurrent or metastatic head and neck cancer, and the early stop for efficacy on a trial of previously treated bladder cancer. Keytruda is also in development in combination with Incyte's IDO1 enzyme inhibitor, epacadostat, and the Phase 3 data is expected to readout in 2018. According to the call, Merck will make regulatory decisions about this combo mid next year.
"We are continuing the launch of Keytruda and looking forward to continued growth. It is a leading treatment in melanoma, and the first new treatment option in head and neck cancer for almost a decade. We are also getting ready for the U.S. first-line launch in NSCLC patients with PD-L1 levels of more than 50%, and for the Japanese launch for melanoma," said Adam H. Schechter, president of Global Human Health.
"We have regulatory submission-worthy data in previously treated advanced urothelial cancer. We are potentially changing the cancer treatment landscape," said Roger Perlmutter, president of Merck Research Laboratories.
Keytruda combination therapies are also showing a lot of potential, whether with chemotherapy or onco-immunotherapy, according to Perlmutter, though chemo combo data isn't expected before September 2017: "We have seen impressive evidence of activity in combinations of immunotherapies and chemotherapy. We need to see what provides the best balance of efficacy and safety."
Merck also achieved another approval yesterday for Zinplava (bezlotoxumab) a monoclonal antibody dosed alongside an antibiotic in Clostridium difficile infections to neutralize one of the toxins and cut the risk of recurrence. This is under review in Europe. The company is also preparing for the launch of Zepatier (elbasvir/grazoprevir) for hepatitis C infection, in Japan.
Earlier in the pipeline, Perlmutter highlighted the company’s work in infectious disease, including hepatitis C infection, bacterial infection and HIV, and also in diabetes. Pfizer and Merck are working together to develop ertugliflozin alone and in combination with Merck's Januvia for the treatment of type 2 diabetes. In June this year the Phase 3 trials met their primary endpoints, and filing for approval is expected before the end of 2016.
Looking at the company strategy moving forward, Schechter said that while the company's focus is on innovation, he saw biosimilars as a commercial opportunity.