Opdivo's Subcutaneous Formulation Shows Promise in Advanced Kidney Cancer: Bristol Myers Squibb's Latest Findings

Bristol Myers Squibb Co BMY released topline data from the Phase 3 CheckMate -67T noninferiority trial of a subcutaneous Opdivo (nivolumab) compared to intravenous (IV) Opdivo for advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy.

Clear cell renal cancer is the most common type of kidney cancer, comprising 80% of all malignant tumors found within the kidney.

The subcutaneous formulation of Opdivo used Halozyme Therapeutics Inc.'s HALO recombinant human hyaluronidase.

The 495-patient study met its co-primary pharmacokinetics endpoints and key secondary endpoint. 

In the first-ever disclosure for the subcutaneous formulation of Opdivo, the CheckMate -67T Phase 3 trial demonstrates activity in advanced or metastatic clear cell renal cell carcinoma.

Also Read: Bristol Myers Squibb Highlights Opdivo Regime Data In Lung Cancer Settings

Subcutaneous nivolumab demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo, the study's co-primary endpoints. 

Additionally, subcutaneous nivolumab showed a non-inferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo, a key secondary endpoint. 

The safety profile of subcutaneous nivolumab was consistent with the IV formulation.

The company will complete a full evaluation of the available CheckMate -67T trial data and work with investigators to present the results at an upcoming medical conference. 

Earlier this month, Bristol Myers' agreed to acquire Mirati Therapeutics Inc MRTX for $58.00 per share in cash, for a total equity value of $4.8 billion. Mirati's assets are a strong fit with Bristol Myers Squibb's portfolio and pipeline and represent an attractive opportunity to grow Bristol Myers Squibb's oncology franchise.

Price Action: BMY shares are up 0.05% at $56.88 on the last check Thursday.