Bristol Myers, Exelixis snag Opdivo-Cabometyx kidney cancer nod to challenge Merck, Pfizer

opdivo
Bristol Myers Squibb and Exelixis have won FDA approval for the combo of Opdivo and Cabometyx in previously untreated kidney cancer. (Bristol Myers Squibb)

Bristol Myers Squibb snagged an FDA go-ahead to open another front in Opdivo's rivalry with Merck & Co.'s Keytruda.

The FDA approved the combination of Opdivo and Exelixis’ tyrosine kinase inhibitor Cabometyx for previously untreated advanced renal cell carcinoma—the exact same indication Merck and Pfizer’s PD-1/TKI pairing, Keytruda and Inlyta, won back in April 2019.

By the looks of their respective clinical data, the two regimens have a tough battle ahead—and one analyst has said the fight might come down to marketing capabilities.

In first-line kidney cancer, Opdivo and Cabometyx cut the risk of death by 40% over Pfizer’s old standard therapy Sutent after a median follow-up of 18 months, the CheckMate-9ER trial showed. The duo also reduced the risk of disease progression or death by 49%, and more than twice as many combo patients responded to treatment.

In the Keynote-426 trial, Keytruda and Inlyta pared down the risk of death by 41% over Sutent after 17 months of follow-up.

RELATED: How will BMS' new Opdivo-Cabometyx kidney cancer combo fare against Keytruda? It may come down to marketing: analyst

Because of the all-but-matching results, SVB Leerink analyst Daina Graybosch has said the competition probably won't be about the data but commercial execution.

To further complicate things, though, Merck and its partner Eisai recently said their Keytruda-Lenvima cocktail also topped Sutent in first-line kidney cancer—also across all three trial marks, including helping patients live longer.

There, Merck believes it could build on existing confidence and familiarity physicians have with Keytruda to market Inlyta and Lenvima as two TKI options alongside its PD-1 inhibitor, Graybosch wrote in a December note after talking to Merck’s chief commercial officer Frank Clyburn.

RELATED: Merck, Eisai further complicate kidney cancer race with Keytruda-Lenvima win

But as Graybosch pointed out, Bristol Myers could apply the same tactic to Opdivo and Cabometyx. Opdivo and its sister CTLA4 immuno-oncology drug Yervoy won an FDA green light in previously untreated kidney cancer in April 2018. Cabometyx boasts an even longer history in the disease; it was first approved by the FDA in 2016 as a single agent for previously treated patients and then in the front-line setting in late 2017.

Clyburn admitted Opdivo and Cabometyx boast competitive data but questioned whether the lower dose used for Cabometyx in the combo versus single agent “may be concerning for some physicians,” Graybosch noted. In the Opdivo regimen, Cabometyx is given at 40 mg once daily, while its monotherapy approval is for the 60-mg strength.