Plenty of immunotherapy-based compounds are already waiting for a share in previously untreated metastatic kidney cancer, but that doesn’t stop Merck and his partner Eisai from trying to get her -into the action.
With data released Saturday at the American Society of Clinical Oncology’s Genitourinary Cancer Symposium showing that the Keytruda-Lenvima pairing could stop disease from getting worse and death, the two pointed to the field that they were on the entrance into the market – and coming to play.
Contrary to Pfizer’s Sutent, considering the unclear level of care at the time the phase 3 trial began, Keytruda and Lenvima (lenvatinib) reduced the risk of disease progression or death by 61% and reduced the risk of death by itself 34%. Patients went on the mid-term combo 23.9 months – just two years shy – before the cancer got worse, compared to just 9.2 months for Sutent.
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Of course, while Sutent was the appropriate comparator at the time, it is no longer the standard of care in place. If eventually adopted, the Keytruda-Lenvima tandem will go up against a range of combs, including Bristol Myers Squibb’s Opdivo-Yervoy duo and Merck’s own mix of Keytruda and Pfizer’s Inlyta (axitinib).
While that last combo has made great strides in the field, Merck preferred to keep sales in the family. In addition to Keytruda, it owns half of Lenvima after agreeing to return up to $ 5.8 billion in 2018.
“Many surgeons have had a profound impact on the results,” said Keytruda and Inlyta, Roy Baynes, MD, Merck’s senior vice president and head of global clinical development. But the images of the two Keytruda combs are slightly different, he said.
“The middle (survival without movement) of a two-year order is very important, and in many ways never seen before,” he said of Keytruda-Lenvima.
However, “we see both of these as competing recommendations for patients,” he said, noting that, in some cases, it may just come down to a physician’s choice and doctors feel more comfortable using Inlyta over Lenvima or vice versa.
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But Merck will have another key player to compete with, and that is the Bristol Myers Squibb archive. Last month, BMS and partner Exelixis received an FDA green light score for a pair of Opdivo and Cabometyx, which, like Pfizer’s Keytruda-Inlyta and Keytruda-Lenvima combos, repair a PD-1 inhibitor with a tyrosine kinase inhibitor . Analysts at the time said that marketing capability could make a big difference in that race, with both options looking competitive.
And then Opdivo and Yervoy, who were the original IO entrants in the field, have a Bristol dual immunotherapy regimen. That combo boasts “strong brand value built from long-term (four-year) long-term survival outcomes,” so it may take a portion of these drugs longer, ”wrote SVB analyst Leerink Daina Graybosch ahead of Saturday’s Merck show at ASCO GU.
But doing so too will not be absolutely essential for Keytruda-Lenvima to see success. “Commercially, we expect Merck and partner Eisai … to market a supplement of lenvatinib over axitinib Pfizer – increasing (renal cell carcinoma incidence) even if it does not they are any share from BMY, “she wrote.