Merck $MRK may not just have a leg up over Bristol-Myers Squibb $BMY in the lucrative field of lung cancer. It looks like the company’s blockbuster checkpoint inhibitor Keytruda — largely considered the preeminent immunotherapy — is on its way to establishing its edge in renal cancer. Ahead of the Genitourinary (GU) Cancers Symposium later this week, an abstract detailing the results of a pivotal study testing a Keytruda combination in previously untreated renal cell carcinoma (RCC) patients cemented the PD-1 drug’s leading status.
Topline data released last October showed a combination of Keytruda and Pfizer’s $PFE tyrosine kinase inhibitor (TKI) Inlyta in the KEYNOTE-426 trial improved overall survival, progression-free survival and overall response rates across risk groups and regardless of PD-L1 status, compared to Pfizer’s Sutent, in first-line RCC patients. Merck offered further detail on Monday, indicating the Keytruda combo significantly improved OS, reducing the risk of death by nearly half (HR 0.53), as well as PFS (HR 0.69).
Analysts cheered the data. Cowen analysts suggested that a TKI/IO combo will emerge as the standard of care in first line RCC, and that they anticipate similar results to emerge from the ongoing CheckMate 9ER trial, which is testing a combination of Opdivo and Exelixis’ $EXEL TKI Cabometyx versus Sutent in RCC patients.
Keytruda+Inlyta showed impressive overall results and will likely gain approval in 1L setting. While these data may cause some volatility in EXEL stock…the ongoing CheckMate 9ER trial should report similar if not better results…Cabo remains the preferred TKI for RCC based on NCCN guidelines. Additionally, we anticipate that many physicians will view KEYNOTE-426 as a class effect (strong synergy between TKI and checkpoint inhibitor), and this may even result in an incremental increase in cabo use in the frontline setting with a checkpoint inhibitor prior to CheckMate 9ER results and potential label expansion.
Credit Suisse’s Vimal Divan said the Keytruda combo’s OS hazard ratio surpassed expectations, considering investors had anticipated a HR around the 0.60 threshold.
“Bristol-Myers has been gaining share in the 1L RCC market with their Opdivo + Yervoy combo but Merck’s data appears superior given a lower OS HR, a positive impact on PFS and an impact being seen across a broader population. Opdivo + Yervoy showed an OS benefit (but not a PFS benefit) over Sutent in the CheckMate-214 trial but only in intermediate and high-risk patients and the benefit, in our view, being driven by the responses seen in patients that were PD-L1 positive. Over time, the availability of a generic version of Inlyta (we assume in 2025) could also provide a cost advantage for the Keytruda + Inlyta regimen over Opdivo + Yervoy,” Divan said.
In its fourth-quarter earnings call, Merck said it has already submitted an application to market Keytruda to treat first line RCC patients, but Pfizer and Merck KGaA on Monday said the FDA had agreed to a speedy review for their application to market a combination of their checkpoint inhibitor Bavencio and Inlyta in RCC patients — the agency is expected to make its decision by June.
“(The) Bavencio combination with Inlyta may get to market in the US first, having been granted priority review by the FDA…based on data from JAVELIN Renal 101. However, we view Keytruda + Inlyta as likely to overtake Bavencio + Inlyta as well given greater physician comfort with Keytruda over Bavencio and the positive OS data that KEYNOTE-426 delivered at the first interim analysis (as compared to JAVELIN Renal 101 where we only saw a PFS benefit at the interim analysis),” Divan added.
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