Second quarter revenues at each Merck & Co. and Bristol-Myers Squibb beat Wall Road estimates this week. But the outcomes did not do a lot to boost share costs, as buyers remained centered on how competitors between the businesses’ rival immunotherapies will shake out, notably in lung most cancers.
Merck recorded gross sales of $10.5 billion for the interval, a 5% year-over-year achieve spurred by its Keytruda franchise, which itself grew almost 90% to $1.67 billion. Bristol-Myers, in the meantime, noticed income enhance 11% 12 months over 12 months to $5.7 billion as gross sales of Opdivo and Eliquis rocketed up 36% and 40%, respectively, to $1.63 billion and $1.65 billion.
Notably, that is the primary quarter the place Keytruda gross sales outpaced Opdivo. Although the Bristol-Myers drug obtained an early lead within the lung most cancers market, Merck has been capable of make up floor by securing approvals within the first-line setting for metastatic non-small cell lung most cancers (NSCLC).
Keytruda (pembrolizumab) and Opdivo (nivolumab) are every authorised throughout a variety of most cancers indications. A kind of, nonetheless, was notably essential in creating the neck-and-neck matchup seen immediately.
In October 2016, the Meals and Drug Administration cleared Keytruda as a first-line remedy for metastatic NSCLC sufferers who’ve PD-L1 expression of no less than 50%. The thumbs up got here simply two months after Opdivo failed a key Part three research of metastatic NSCLC sufferers with PD-L1 expression of no less than 5%.
Approval in that earliest setting gave Keytruda the foothold it wanted to seize higher parts of the NSCLC market. Since then, U.S. regulators have OK’d the drug together with chemotherapy for the first-line remedy for metastatic nonsquamous NSCLC, no matter PD-L1 expression.
Opdivo alternatively hasn’t but locked down a first-line lung most cancers indication, although Bristol-Myers has submitted a supplemental Biologics License Software for Opdivo plus Yervoy (ipilimumab) as a first-line remedy for sufferers with superior NSCLC who’ve sure ranges of a biomarker referred to as tumor mutational burden. The FDA set a goal motion date of Feb. 20, 2019 for the appliance.
Keytruda’s early edge, although, can be stiff competitors, and never only for Opdivo.
Roche’s Tecentriq (atezolizumab), as an illustration, is indicated for NSCLC sufferers whose illness progressed throughout or after platinum-containing chemo, and for these with EGFR or ALK abnormalities of their tumors who had illness development following remedy with an FDA-approved drug.
In June, Merck unveiled knowledge displaying Keytruda plus chemo — which, once more, is just authorised as a first-line for metastatic non-squamous NSCLC —lowered danger of loss of life by 36% in comparison with chemo alone for sufferers with the squamous type of the illness.
One other research offered at the moment, KEYNOTE-042, discovered sufferers who acquired Keytruda monotherapy lived a median 4 to eight months longer than these solely getting chemo.
All in all, the trial wins have helped safe Keytruda’s place because the drug to beat in lung most cancers, and particularly as an preliminary remedy.
“I can tell you the feedback on the chemo combo in the U.S. has been very well received, and as I mentioned about two-thirds of new patients are now starting on Keytruda when you exclude the EGFR and ALK — and that’s a 20-point share increase since AACR,” mentioned Adam Schechter, president of worldwide human well being at Merck, throughout an earnings name Friday.
“I’ve always said this is not going to be a big bolus of patients because these are patients coming into the market as they are diagnosed,” Schechter added. “But as you continue to grow new patient share, those patients become part of the [prescription] base and that represents a very large opportunity for growth for us … moving forward.”
Bristol-Myers, conversely, has been optimistic about holding down the second-line enviornment, and continues to take a look at label-expanding alternatives for Opdivo, particularly with regard to mixture regimens.
“We expect the second line lung cancer market to stay relatively stable outside of the U.S., with shares at roughly 40% to 50% range,” Christopher Boerner, head of Bristol-Myers’ U.S. business enterprise, mentioned on the corporate’s July 26 earnings name.
“While we do expect the dynamics of the frontline lung cancer market to impact second line, we won’t likely see that until well into 2019 for a number of reasons — notably the timing of regulatory approvals and then access decisions in first line as well as the fact that we didn’t see an earlier approval for PD-1 in chemotherapy in first line outside of the U.S.”