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Opdivo Plus Cabometyx Combo Shows Superior Clinical Benefit Versus Sunitinib In Late-Stage Kidney Cancer Study

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  • Bristol Myers Squibb Co (NYSE: BMY) and Exelixis Inc (NASDAQ: EXEL) have announced updated data from Phase 3 CheckMate 9ER trial, evaluating the combination of former's Opdivo (nivolumab) and latter's Cabometyx (cabozantinib) drug compared to Pfizer Inc's (NYSE: PFE) Sutent (sunitinib) in the first-line treatment of advanced renal cell carcinoma.
  • BMY will present the data at the virtual American Society of Clinical Oncology 2021 Genitourinary Cancers Symposium.
  • With a median follow-up of two years (23.5 months), Opdivo, combined with Cabometyx, doubled median progression-free survival (17.0 months vs. 8.3 months) compared to sunitinib, the trial's primary endpoint.
  • Almost twice as many patients responded to the combination treatment vs. sunitinib (54.8% vs. 28.4%). Opdivo plus Cabometyx demonstrated a 34% reduction in the risk of death compared to sunitinib.
  • In an exploratory analysis, the combination was associated with a disease control rate of 88.2% vs. 69.9% compared to sunitinib.
  • 6.6% of patients discontinued treatment in the combination arm due to adverse events, compared to 9.7% in Opdivo only and 7.2% discontinued in Cabometyx.
  • In a subgroup analysis of 75 patients with sarcomatoid features, the combination reduced the risk of death by 64% vs. sunitinib and demonstrating better progression-free survival (10.3 months vs. 4.2 months) and overall response rate (55.9% vs. 22.0%).
  • Price Action: In the premarket session on the last check Tuesday, EXEL shares are trading 1.4% higher at 24.45, and BMY is up 0.42% at $60.48. PFE shares are marginally higher by 0.09% at $34.85.
 

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Posted-In: Kidney Diseases Phase 3Biotech News FDA Top Stories General

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