Bristol Myers Squibb’s combination of Opdivo and Yervoy was the first immuno-oncology regimen to snag an FDA approval for newly diagnosed kidney cancer. While multiple therapies have since entered the market, the New York pharma is now trumpeting five-year data to fend off competition.
In previously untreated renal cell carcinoma patients with intermediate- and poor-risk prognostic factors, Opdivo and Yervoy continued to show a strong life extension benefit over Pfizer’s aging small-molecule drug Sutent at the five-year mark and a death risk reduction of 32%, BMS reported at the European Society for Medical Oncology annual congress.
Patients on the dual immunotherapy lived a median 47 months versus 27 months for those on Pfizer's targeted therapy. Patients who lived to the three-year mark were 79% likely to remain alive for two more years. For those whose tumors hadn’t progressed at three years, they were 90% likely to stay progression-free for another two years, BMS reported.
The five-year data are important because they support Opdivo and Yervoy as a durable therapy for front-line kidney cancer, Jonathan Cheng, BMS’ head of oncology development, said in an interview.
The update of the phase 3 CheckMate-214 trial came as several combinations of PD-1 and tyrosine kinase inhibitors (TKIs) have won FDA go-aheads in the past few years with competitive survival data. These recent nods include BMS' own cocktail of Opdivo with Exelixis’ Cabometyx. But obviously the real trouble on BMS’ mind is Merck & Co’s Keytruda combos with either Pfizer’s Inlyta or—perhaps more importantly—Eisai-partnered Lenvima.
In an investor note in February, SVB Leerink analyst Daina Graybosch ruled that the Keytruda-Lenvima regimen may have a shot at leadership across the checkpoint inhibitor class in front-line kidney cancer. That’s because its two-year overall survival rate, at 79%, looks to be the best, and so does its ability to induce complete responses and rapid tumor shrinkage.
But none of those regimens have the kind of long-term data the Opdivo-Yervoy combo has. Cheng suggested treatment choice would be individualized and that five-year data offer more information to better help patients and physicians decide which therapies to choose.
Interviews SVB Leerink conducted with industry experts in 2020 backed up Cheng’s argument that long-term data are helpful. Oncologists prefer Opdivo and Yervoy, especially for its approved population of patients with intermediate- and poor-risk factors, “given the combination’s strong, stable survival tail with immune-related adverse events that are often more tolerable than [adverse events] with TKIs,” Graybosch wrote in the note.
For the Opdivo-Cabometyx pairing, BMS also wants to continue to follow up patients in the CheckMate-9ER trial “because the toxicity profile is a little bit distinct, and the activity you’ve seen might change how one thinks about whether you have bulky symptomatic disease or you have more lesser-volume and more indolent disease,” Cheng said.