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