U.S. Markets open in 28 mins

Exelixis & Bristol-Myers Initiate Trial on Opdivo-Cabometyx

Zacks Equity Research

Exelixis, Inc. EXEL and Bristol-Myers Squibb Company BMY announced that they have initiated a phase III trial, CheckMate 9ER. The trial will evaluate Bristol-Myers’ immuno-oncology drug Opdivo in combination with Exelixis’ Cabometyx or Opdivo and Yervoy in combination with Cabometyx versus Pfizer’s PFE Sutent in patients with previously untreated, advanced or metastatic renal cell carcinoma (RCC).

The primary endpoint for the trial is progression-free survival (PFS).

The open-label, randomized, multi-national phase III trial will enroll approximately 1,014 patients with previously untreated advanced or metastatic RCC. Patients will be randomized 1:1:1 to one of the three arms: Cabometyx and Opdivo, Cabometyx, Opdivo and Yervoy, or Sutent. The primary efficacy analysis will compare the doublet combination versus Sutent and the triplet combination versus Sutent in intermediate/poor risk patients with RCC.

We note that Cabometyx (tablet formulation of cabozantinib) is approved for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. On the other hand, Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy – classic Hodgkin lymphoma in both the U.S. (May 2016) and the EU (Nov 2016).

In Nov 2016, the FDA approved Opdivo for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.

Label expansion into additional indications would give the product access to a higher patient population and increase the commercial potential of the drug.

As per data from The American Cancer Society, kidney cancer is among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.

In early 2017, Exelixis announced agreements with Bristol-Myers Squibb and Roche Holdings RHHBY to collaborate on the development of cabozantinib in combination with immunotherapy agents.  In June, Exelixis initiated the dose-escalation stage of a phase Ib trial of cabozantinib in combination with Tecentriq. The drug will be evaluated in patients suffering from locally advanced or metastatic urothelial carcinoma (UC) or RCC. A potential label expansion will further boost sales.

Exelixis’ shares have moved up 71.7% year to date compared with the Zacks classified Medical - Biomedical and Genetics industry’s gain of 6.6%.

Additionally, Bristol-Myers announced that the FDA accepted its supplemental New Drug Application (sNDA) for the label expansion of Sprycel. The sNDA seeks to include the indication of Philadelphia chromosome-positive chronic phase (CP) chronic myeloid leukemia (CML) in children, and a powder for oral suspension (PFOS) formulation.

The application is under priority review with an action date of Nov 9. We note that Sprycel is already approved for adults with Philadelphia chromosome-positive (Ph+) CML in chronic phase (CP) who are resistant or intolerant to prior therapy including Gleevec.

Zacks Rank

Exelixis currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

More Stock News: 8 Companies Verge on Apple-Like Run

Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.

A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Roche Holding AG (RHHBY) : Free Stock Analysis Report
Bristol-Myers Squibb Company (BMY) : Free Stock Analysis Report
Pfizer, Inc. (PFE) : Free Stock Analysis Report
Exelixis, Inc. (EXEL) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research