Exelixis, Inc.
EXEL
has announced that the late-stage study COSMIC-313 met its primary endpoint.
COSMIC-313 is an ongoing phase III study evaluating the combination of Cabometyx (cabozantinib),
Bristol Myers’
BMY
Opdivo (nivolumab) and Yervoy (ipilimumab) versus the combination of Opdivo and Yervoy in patients with previously untreated advanced intermediate- or poor-risk renal cell carcinoma (RCC).
The primary endpoint is progression-free survival (PFS) and the secondary endpoint is overall survival (OS). Exelixis is funding the study, and Bristol Myers is providing Opdivo and Yervoy for use in this study.
Cabometyx, in combination with Opdivo and Yervoy, significantly reduced the risk of disease progression or death compared with the combination of Opdivo and Yervoy. The study demonstrated significant improvement in PFS at the primary analysis.
However, at a prespecified interim analysis for the secondary endpoint of OS, the combination of Cabometyx, Opdivo and Yervoy versus the combination of Opdivo and Yervoy did not demonstrate a significant benefit and the study will continue to the next analysis of OS.
Exelixis intends to discuss the results with the FDA to determine the next steps toward a potential regulatory submission for the combination regimen for patients with previously untreated advanced intermediate- or poor-risk RCC.
Shares have gained 12.6% in the year so far against the
industry
’s decline of 20.3%.
Image Source: Zacks Investment Research
Exelixis’ lead drug Cabometyx, approved for treating patients with RCC and patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar, aids the company’s momentum amid stiff competition.
Additional label expansions will further boost growth.
In particular, the approval of Cabometyx for patients with advanced RCC as a first-line treatment in combination with Opdivo has fueled sales of the drug.
Bristol-Myers’ Opdivo is one of the leading revenue generators of the company and is approved for various oncology indications.
Cabometyx is also approved for previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC).
Other candidates in Exelixis’ pipeline include XL092, a next-generation oral tyrosine kinase inhibitor (TKI); XB002, an antibody-drug conjugate (ADC) that targets tissue factor (TF); XL102, a potent, selective and orally bioavailable covalent inhibitor of cyclin-dependent kinase 7 (CDK7); and XL114, a novel anti-cancer compound that inhibits the CARD11-BCL10-MALT1 (CBM) complex.
Exelixis is looking to build a differentiated next-generation pipeline in oncology through strategic collaborations. The successful development of additional candidates will diversify its revenue base and reduce dependence on lead drug.
Competition is stiff in the RCC space, and capturing additional market share might become tough for Exelixis.
Merck’s
MRK
Keytruda, in combination with
Pfizer’s
PFE
Inlyta, is also indicated for the first-line treatment of patients with advanced RCC.
Merck’s Keytruda, an anti-PD-1 therapy, is approved for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy or nephrectomy and resection of metastatic lesions.
Pfizer’s Inlyta has shown strong performance, driven by continued adoption in the United States and Europe. PFE’s older drug Sutent is also approved for advanced RCC.
Exelixis currently carries a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
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