Keytruda + Lenvima demonstrates long-term, durable survival benefit vs. sunitinib as first-line treatment for advanced RCC in phase III trial

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After four years of follow-up, final pre-specified overall survival analysis from the pivotal phase III CLEAR/KEYNOTE-581 trial showed that Keytruda plus Lenvima maintained a clinically meaningful OS benefit versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma, reducing the risk of death by 21%. 

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The phase III CheckMate -67T trial, evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy, demonstrated noninferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo. 
Merck and Moderna Inc. have initiated the phase III randomized INTerpath-002 trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Keytruda as adjuvant treatment in patients with completely resected (R0) Stage II, IIIA or IIIB (with nodal involvement [N2]) non-small cell lung cancer.