No price competition in PD-(L)1? That might not last long as EQRx, CStone read out late-stage win for challenger
Drug pricing disruptor EQRx has made a show about its mission to aggressively discount drug markets dominated by expensive medicines with no meaningful price competition. One of the most obvious targets is PD-(L)1, and now one of EQRx’s partnered drugs is getting its affairs in order for a late market entry.
EQRx and CStone’s sugemalimab hit its primary endpoint of progression-free survival as a consolidation therapy for patients with stage III non-small cell lung cancer whose disease hasn’t progressed after concurrent or sequential chemoradiotherapy, the company said Friday.
The GEMSTONE-301 study followed up results from GEMSTONE-302, which tested sugemalimab against placebo in Stage IV NSCLC. That Phase III study, with results presented last year, was also a win, and taken together the data “set the stage” for regulatory filings, the companies said.
The Stage III test looked at PFS as determined by a blinded independent review against placebo as its primary endpoint, with OS, investigator-determined PFS and safety as the secondary endpoints. Subgroup analyses showed the drug was associated with clinical benefit regardless of whether patients received concurrent or sequential chemoradiotherapy prior to dosing, the companies said.
If sugemalimab does make it across the finish line, it would join a growing chorus of anti-PD-(L)1s, with many of the late-stage entrants coming out of Chinese R&D outfits. The market is led by Merck’s Keytruda and its expansive clinical program with Bristol Myers Squibb’s Opdivo pretty far behind in terms of sales.
But even with a recent late entry — GlaxoSmithKline’s Jemperli was the latest with an approval in April — price competition has so far not been a factor in the PD-(L)1 market. That’s where EQRx and CStone think they might have a differentiating angle, and they haven’t been shy about it.
“EQRx was created to address this challenge head-on by bringing high-quality medicines to patients at much lower prices,” EQRx CEO Alexis Borisy said in a statement. “PD(L)1 therapies are the backbone of cancer treatment, and we see tremendous opportunity for sugemalimab as a monotherapy or in combination regimens, lowering the overall costs of immunotherapy options.”
Of course, EQRx will be running with big dogs on the market with big commercial teams. In fact, Bernstein analyst Ronny Gal in a March open letter to Regeneron CEO Len Schleifer pleaded with the drugmaker to leverage its immense marketing team to a discounting strategy itself.
Gal argued that price competition has not favored innovation in oncology, and oncologists have usually leaned toward more expensive drugs given their own financial incentives. But with attitudes around pricing changing, Regeneron could have an opportunity to undercut its competitors and snag a big share of the market before more competitors like EQRx enter the field and inevitably take the discount route.
If Regeneron follows that advice, Gal calculated, it could secure an additional 10% market share across some of the bigger indications, including non-small cell lung cancer, renal cell carcinoma and melanoma. Add that up and it could spell $2 billion in sales per year for Libtayo. Meanwhile, Regeneron could still ask top-dollar for drugs used in combination with the anti-PD-1.