Plenty of immunotherapy-based combinations are already vying for share in previously untreated, metastatic kidney cancer, but that’s not stopping Merck and partner Eisai from trying to get in on the action.
With data unveiled Saturday at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium showing that their Keytruda-Lenvima pairing could stave off disease worsening and death, the duo gave the field a heads up that they were on their way into the market—and coming to play.
Against Pfizer’s Sutent, considered the unequivocal standard of care at the time the phase 3 trial began, Keytruda and Lenvima (lenvatinib) posted a 61% reduction in the risk of disease progression or death and cut the risk of death alone by 34%. Patients on the combo went a median 23.9 months—just shy of two years—before their cancer worsened, versus just 9.2 months for Sutent.
Of course, while Sutent was the appropriate comparator at the time, it’s no longer the standard of care in the space. If eventually approved, the Keytruda-Lenvima tandem will be going up against a range of combos, including Bristol Myers Squibb’s Opdivo-Yervoy duo and Merck’s own combination of Keytruda and Pfizer’s Inlyta (axitinib).
While that latter combo has made headway in the field, Merck would prefer to keep sales in the family. In addition to Keytruda, it owns half of Lenvima after agreeing to shell out up to $5.8 billion back in 2018.
“Many treating physicians have been quite impressed with the results” that Keytruda and Inlyta have produced, Roy Baynes, M.D., Merck senior vice president and head of global clinical development. But the profiles of the two Keytruda combos are a little different, he pointed out.
“Median (progression-free survival) on the order of two years is really a pretty significant, and in many ways unprecedented, finding,” he said of Keytruda-Lenvima.
Still, “we do see both of these as very competitive propositions for patients,” he said, noting that in some cases, it may just come down to physician preference and whether doctors feel more comfortable using Inlyta over Lenvima or vice-versa.
But Merck will have another major player to contend with, and that’s archrival Bristol Myers Squibb. Last month, BMS and partner Exelixis scored an FDA green light for a pairing of Opdivo and Cabometyx, which, like Pfizer’s Keytruda-Inlyta and Keytruda-Lenvima combos, pairs a PD-1 inhibitor with a tyrosine kinase inhibitor. Analysts at the time said marketing prowess could make all the difference in that race, with both options looking competitive.
And then there’s Bristol’s dual-immunotherapy regimen of Opdivo and Yervoy, which was the field’s original I-O entrant. That combo boasts “strong brand value built from stable long-term (four-year) survival outcomes,” so stealing share from those drugs “may take longer,” SVB Leerink analyst Daina Graybosch wrote ahead of Merck’s Saturday presentation at ASCO GU.
But doing so also won't be totally necessary for Keytruda-Lenvima to see success. "Commercially, we expect Merck and partner Eisai ... will aggressively market add-on of lenvatinib over Pfizer’s axitinib—increasing (renal cell carcinoma) revenue even if they take no share from BMY," she wrote.