With several new immuno-oncology drugs on their way to the U.S. from Chinese biopharma companies, the already crowded PD-1/L1 market about to get even more so. And that's put Opdivo developer Bristol Myers Squibb on notice.
While Bristol Myers isn’t paranoid about new PD-1 competition, the risk of commoditization—as newer entrants undercut established drugs on price—could be a bigger problem that “we need to stay on top of,” the company’s chief commercial officer Chris Boerner said on a conference call Thursday.
At least three Chinese-made PD-1s are looking to launch in the U.S. in the next three years, with U.S. partners in Novartis, Eli Lilly and Coherus BioSciences. Although none of the drugs has proven superior to the currently available meds, the new entrants are expected to offer discounted prices to win market share.
BMS is paying attention to the up-and-coming drugs, Boerner said, but it's not so concerned about competition on the merits. A price-driven battle might be more disruptive.
Low cost isn't the only thing that drives commoditization, Boerner said. Payers, physicians and patients also have to consider products interchangeable.
“The risk of both of these things coming together likely varies by geography, healthcare system and maybe even by therapeutic setting, but we pay very close attention to this,” he said. At least for now, the greatest risks don’t overlap with Opdivo’s largest markets, he added.
Opdivo is the second best-selling PD-1/L1 checkpoint inhibitor among seven existing options. Under pressure from Merck & Co.’s market-leading Keytruda, the drug has hit a growth bottleneck lately. During the first quarter, it brought in sales of $1.72 billion, down 3% year over year—after a similar year-over-year decline in 2020.
Bristol blamed COVID-19 for part of that decline, particularly internationally. In the U.S., the drug maintains a low double-digit share in the biggest area, first-line non-small cell lung cancer.
The company argues Opdivo will start growing again this year, thanks to a strategy of churning out new data and winning new approvals that can help the med defend itself against the competition.
These include a combo with Exelixis’ Cabometyx in previously untreated kidney cancer and with chemotherapy in previously untreated stomach cancer, as well as potential launches in post-surgery esophageal cancer and post-surgery muscle-invasive bladder cancer.
As most metastatic cancer fields fill up with competition, PD-1/L1 developers are looking for approvals in newly diagnosed patients before and after surgery. Boerner noted that the treatment rate for some of those uses—known as adjuvant and neo-adjuvant—remain relatively low, so even after it wins those approvals, sales will likely ramp up slowly.
Meanwhile, Bristol’s looking to introduce its third checkpoint inhibitor in addition to Opdivo and CTLA4 inhibitor Opdivo. A fixed combo of Opdivo and investigational LAG-3 antibody relatlimab recently topped solo Opdivo in first-line melanoma.
Currently, the Opdivo-Yervoy combo takes up about 35% to 40% of front-line melanoma share, and single-agent I-O use constitutes another 30%. With relatlimab, the company’s aiming to tap into the rest of the market, Boerner said.
The company’s also eyeing the front-line NSCLC market, having launched an early study adding chemotherapy to the Opdivo-relatlimab pair, with the hope of starting a phase 3 trial by the end of the year, Bristol’s chief medical officer Samit Hirawat said on the call.
In addition, Bristol recently launched two CAR-T cell therapies, CD19-targeted Breyanzi and BCMA-targeted Abecma. Both drugs require designated treatment centers for administration. So far, 55 sites for Breyanzi and more than 40 for Abecma have been activated.
All told, Bristol saw sales increase 3% year over year to $11.1 billion in the first quarter. Multiple myeloma drug Revlimid led the pack with a Q1 haul of $2.94 billion, followed by oral blood thinner Eliquis, which turned in $2.89 billion. Both drugs reported growth.