- Second quarter revenues at both Merck & Co. and Bristol-Myers Squibb beat Wall Street estimates this week. Yet the results didn't do much to raise share prices, as investors remained focused on how competition between the companies' rival immunotherapies will shake out, particularly in lung cancer.
- Merck recorded sales of $10.5 billion for the period, a 5% year-over-year gain spurred by its Keytruda franchise, which itself grew nearly 90% to $1.67 billion. Bristol-Myers, meanwhile, saw revenue increase 11% year over year to $5.7 billion as sales of Opdivo and Eliquis rocketed up 36% and 40%, respectively, to $1.63 billion and $1.65 billion.
- Notably, this is the first quarter where Keytruda sales outpaced Opdivo. Though the Bristol-Myers drug got an early lead in the lung cancer market, Merck has been able to make up ground by securing approvals in the first-line setting for metastatic non-small cell lung cancer (NSCLC).
Keytruda (pembrolizumab) and Opdivo (nivolumab) are each approved across a wide range of cancer indications. One of those, however, was particularly important in creating the neck-and-neck matchup seen today.
In October 2016, the Food and Drug Administration cleared Keytruda as a first-line therapy for metastatic NSCLC patients who have PD-L1 expression of at least 50%. The thumbs up came just two months after Opdivo failed a key Phase 3 study of metastatic NSCLC patients with PD-L1 expression of at least 5%.
Approval in that earliest setting gave Keytruda the foothold it needed to capture greater portions of the NSCLC market. Since then, U.S. regulators have OK'd the drug in combination with chemotherapy for the first-line therapy for metastatic nonsquamous NSCLC, regardless of PD-L1 expression.
Opdivo on the other hand hasn't yet locked down a first-line lung cancer indication, though Bristol-Myers has submitted a supplemental Biologics License Application for Opdivo plus Yervoy (ipilimumab) as a first-line treatment for patients with advanced NSCLC who have certain levels of a biomarker called tumor mutational burden. The FDA set a target action date of Feb. 20, 2019 for the application.
Keytruda's early edge, though, will be stiff competition, and not just for Opdivo.
Roche's Tecentriq (atezolizumab), for instance, is indicated for NSCLC patients whose disease progressed during or after platinum-containing chemo, and for those with EGFR or ALK abnormalities in their tumors who had disease progression following treatment with an FDA-approved drug.
In June, Merck unveiled data showing Keytruda plus chemo — which, again, is only approved as a first-line for metastatic non-squamous NSCLC —reduced risk of death by 36% compared to chemo alone for patients with the squamous form of the disease.
Another study presented at that time, KEYNOTE-042, found patients who received Keytruda monotherapy lived a median four to eight months longer than those only getting chemo.
All in all, the trial wins have helped secure Keytruda's place as the drug to beat in lung cancer, and especially as an initial treatment.
"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," said Adam Schechter, president of global human health at Merck, during an earnings call 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 arena, and continues to look at label-expanding opportunities for Opdivo, especially with regard to combination 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. commercial business, said on the company's July 26 earnings call.
"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."