Keytruda’s positive overall survival data in the Keynote-426 first-line renal cell carcinoma trial means that Pfizer and Merck KGaA need to show flawless results in a full readout of the Bavencio Javelin Renal 101 trial at Esmo this weekend. Merck & Co today said that in Keynote-426 the combination of Keytruda and Pfizer’s Inlyta showed a significant improvement in both overall and progression-free survival versus Pfizer’s Sutent. So far, Pfizer and Merck KGaA have said only that Javelin Renal 101 has read out positively for progression-free survival, favouring Bavencio plus Inlyta versus Inlyta alone, although it will proceed to an overall survival analysis (Pincer movement squeezes Exelixis in kidney cancer, September 12, 2018). Potentially favouring Bavencio in this setting is that it scored in all comers, and that Pfizer might be able to bundle Bavencio and Inlyta together. Merck & Co says Keynote-426 results were consistent across subgroups; it is possible for any benefit in all comers to be driven by very strong results in PD-L1-positive patients, however.
|First line PD-(L)1 trials in renal cell carcinoma|
|Opdivo+Yervoy||Bristol-Myers Squibb||Checkmate-214||OS HR 0.63 p<0.0001|
|Bavencio+Inlyta||Pfizer/Merck KGaA||Javelin Renal 101||Positive PFS in PD-L1 +ve and all comers|
|Keytruda+Inlyta||Merck & Co||Keynote-426||Positive PFS and OS in all comers|