Merck & Co. Inc.'s Keytruda and Bristol-Myers Squibb Co.'s Opdivo will once again face off at the American Society of Clinical Oncology's Annual Meeting May 31 to June 4, the most recent in a five-year battle for dominance of the cancer market.
The two pharma giants will present the latest research from their ongoing efforts to discover what their respective drugs can do in the cancer space.
Both drugs have racked up U.S. Food and Drug Administration nods since their original approvals in 2014. Keytruda currently holds the lead with approval in the U.S. for 19 separate indications — including expanded and combination treatments — while Opdivo has 15. The drastic lead taken by Keytruda has come about only recently: since August 2018, Keytruda has picked up seven new uses in cancer while Opdivo has been stagnant on the regulatory front.
Both immuno-oncology drugs work by triggering the immune system to attack cancer cells by inhibiting the PD-1 arm of healthy cells, which in turn prevents the corresponding PD-L1 arm of cancer cells from latching to the healthy cells. They are called immune checkpoint inhibitors.
Lung cancer has been a mainstay for both treatments, with Keytruda holding the edge currently, but at ASCO the companies will be highlighting a wide array of clinical trial results.
Merck will present results in non-small cell lung cancer with Keytruda alone, and in combination with Eli Lilly and Co.'s Alimta and chemotherapy. Other results will be released in kidney cancer, head and neck cancer and liver cancer.
The non-small cell lung cancer trial called Keynote-001 goes back five years and will provide insight into how effective Keytruda is over the long term, as well as how long patients can survive with treatment.
Bristol-Myers will report interim results from trials combining Opdivo and its cancer drug Yervoy in melanoma, liver cancer and kidney cancer.
Credit Suisse analyst Vamil Divan said in a May 22 note that lung cancer is a major focus for drug companies due to its significant market potential. Divan said that both Merck and Bristol-Myers, specifically, have emphasized the newer uses of their drugs as areas that will contribute significantly to revenue streams.
A storied rivalry
Although Merck's Keytruda beat Bristol-Myers to market by three and a half months, Opdivo was the better-selling treatment until the second quarter of 2018, when it was surpassed by Keytruda. During that quarter, Opdivo pulled in $1.62 billion in sales to Keytruda's $1.66 billion.
More recently, in the first quarter of 2019, Keytruda solidified its lead with $2.27 billion in sales worldwide to Opdivo's $1.8 billion.
That track record is expected to continue, according to Credit Suisse's Divan, citing sales data from an April 2019 report by market intelligence firm Symphony Health. Divan expects Keytruda sales to hit $2.45 billion globally in the second quarter of 2019, compared to Opdivo's $1.79 billion.
"Keytruda has emerged as the clear leader in the immuno-oncology space and we continue to expect Keytruda to gain traction and increase its lead over Opdivo," Divan said.
Opdivo hit the market first in areas such as lung and kidney cancer, but Keytruda currently boasts the latest U.S. approvals in those spaces. Keytruda's performance in lung cancer has distinguished the drug in the field while Opdivo has trailed behind.
Bristol-Myers' drug has also faced competition from other treatments, such as Roche Holding AG's Tecentriq in the lung cancer market. But when paired with Bristol-Myers' other cancer drug Yervoy, Opdivo has seen success in melanoma, kidney cancer and colorectal cancer.
Colorectal cancer is one for which Keytruda has not answered back.
Nevertheless, Keytruda has found wins in kidney cancer after an April regulatory approval in combination with Pfizer Inc.'s drug Inlyta. That FDA nod was the first approval for the combination of an immuno-oncology drug and a kinase inhibitor, using two separate mechanisms to fight cancer.
Of course, Bristol-Myers is hot on Merck's heels in the same type of cancer, with a phase 3 clinical trial underway combining Opdivo with Exelixis Inc.'s kinase inhibitor Cabometyx.
Both Keytruda and Opdivo have also demonstrated some weakness in recent late-stage trials in key areas.
Keytruda's notable misses have occurred in liver cancer and triple-negative breast cancer, both phase 3 trials. Opdivo has stumbled in brain cancer and small cell lung cancer.
The 2019 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from around the world, with more than 2,400 study abstracts to be presented on site and an additional 3,200 abstracts to be published online.