fiercepharmaJuly 30, 2018
Tag: Keytruda , Bristol-Myers Squibb , Opdivo
Merck & Co.’s blockbuster cancer drug Keytruda has delivered again in the second quarter, and this time, it has seized the PD-1/L1 crown from Bristol-Myers Squibb’s archrival Opdivo.
For the second quarter, Keytruda sold $1.67 billion, an increase of about 14% sequentially or nearly 90% year over year, narrowly beating Opdivo’s $1.63 billion in the same three months. Keytruda has been growing sequentially every quarter since it was put on the market in 2014, but this is the first full quarter it has surpassed Opdivo.
Analysts have seen this day coming. One big reason for the boost? In first-line nonsquamous non-small cell lung cancer, the drug, combined with Eli Lilly’s Alimta and platinum chemo, showed significant improvements in overall survival. The data showed a 51% reduction in the risk of death, compared with chemo alone, the drugmaker previously announced at the American Association for Cancer Research annual meeting in April.
The FDA has yet to make a decision on that new use, but physicians and patients have apparently been moved by the big showing, as the majority of previously untreated new patients are now taking the drug, and that will read well into longer-term revenue as well, according to executives.
"About two-thirds of new patients are now starting off on Keytruda when you exclude EGFR and ALK, and that’s a 20-point share increase since AACR," Adam Schechter, Merck’s president of Global Human Health, said on the company’s Q2 earnings call. "As you continue to grow new patient share, those patients become the part of the Rx base, and that represents a very large opportunity of growth for us moving forward."
Moreover, at the American Society of Clinical Oncology annual meeting in June, Keytruda also upped Roche’s Tecentriq with a larger progression-free survival benefit in squamous patients and rolled out OS data that Roche didn’t have. As Schechter put it, that should enable Keytruda to become the standard of care in this population as well.
Going forward, Merck still sees lots of room for growth in the lucrative lung cancer market. "With the strength that we’ve seen in our clinical programs, our indication should be able to represent about 80% of all non-small cell lung cancer patients. Overall survival is the gold standard, that’s why I believe there’s still significant opportunity there," said Schechter on the call.
Markets outside of the U.S. and in other indications will also help, said Schechter. Currently, 40% of Ketyruda sales come from outside of the U.S., and that’s when it was only launched as monotherapy in Europe but not as combination. It was just approved in China to treat patients with advanced melanoma, a month after Opdivo was approved in lung cancer. Besides, it was also approved in head and neck tumor, bladder cancer and all microsatellite instability-high (MSI-H) cancers regardless of the location.
Overall, the company reported a revenue increase of 5% to $10.5 billion, coming ahead of analysts’ consensus of $10.3 billion, according to Goldman Sachs analyst Jami Rubin. Sales from diabetes meds Januvia and Janumet were flat at $1.54 billion, while HPV vaccines Gardasil and Gardasil 9 jumped 30% to $608 million.
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