Pfizer and its Germany-based partner Merck KGaA finally have some good news to celebrate in their long-fought battle to broaden the market for their PD-1/PD-L1 inhibitor Bavencio: an FDA approval of the drug, in combination with Pfizer’s Inlyta, for the first-line treatment of patients with advanced kidney cancer.
But the approval will set Pfizer up for a tough rivalry, not only with Bristol-Myers Squibb, which won FDA approval for a combination of its immuno-oncology drugs Opdivo and Yervoy in first-line kidney cancer last April, but also with Merck—the American one.
Merck nabbed FDA approval less than a month ago for a combination of its PD-1 blockbuster Keytruda with Inlyta in first-line kidney cancer. And several Wall Street analysts are betting Merck will come out the winner in this three-way battle.
Why? It comes down to clinical data.
In February, Merck unveiled trial data showing that its combination treatment cut the risk of death by more than 40% in kidney cancer patients, regardless of whether they had the tumor biomarker PD-L1. That sets it apart from Opdivo-Yervoy and Bavencio-Inlyta, both of which showed that PD-L1 levels predicted efficacy.
In the trial leading to the approval of Bavencio-Inlyta, the combination was compared to the current standard of care, Pfizer’s Sutent. The combo reduced the risk of disease progression or death by 31% and extended progression-free survival by 5.4 months, according to a statement from Pfizer and Merck KGaA.
But during the European Society for Medical Oncology meeting last year, Pfizer and Merck KGaA reported that in patients with the PD-L1 biomarker, the combo held off disease progression by 13.8 months versus just 7.2 months for patients with high levels of PD-L1 who were taking Sutent. That’s one reason Credit Suisse analyst Vamil Divan believes oncologists treating kidney cancer will choose Keytruda over Bavencio in deciding which drug to pair with Inlyta.
“Based on our conversations with experts, we expect the [Keytruda] combo to quickly be adopted in the majority of new patients,” Divan wrote in a note to clients in April.
Still, investors will no doubt see the opportunity to expand Bavencio’s market as a welcome turnaround for the drug, which has suffered several disappointments over the last year. In March, the company and Merck KGaA ditched a phase 3 trial of Bavencio combined with chemo and Pfizer’s Talzenna in ovarian cancer. It was the third failure of Bavencio in ovarian cancer. The drug had previously flunked trials in solid tumors, gastric cancer and lung cancer.
That’s only making the competitive landscape more difficult for Bavencio, which was the fourth-to-market PD-1/PD-L1 therapy behind Keytruda, Opdivo and Roche’s Tecentriq.
Credit Suisse’s Divan estimates Bavencio will bring in $150 million in sales for Pfizer this year and double that next year. If Pfizer and Merck KGaA continue to succeed in their efforts to expand the market for the drug, its sales could balloon to $772 million in 2025, he estimates.