Exelixis, Inc
.
EXEL
announced that the late-stage CONTACT-01 study failed to achieve its primary endpoint of overall survival at the final analysis.
CONTACT-01 is a phase III study evaluating the lead drug Cabometyx (cabozantinib) in combination with
Roche’s
RHHBY
Tecentriq (atezolizumab) versus docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) without actionable mutations who experienced disease progression on or after treatment with an immune checkpoint inhibitor and platinum-containing chemotherapy.
The open-label study enrolled 366 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of docetaxel. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, objective response rate and duration of response. CONTACT-01 was sponsored by Roche and co-funded by Exelixis.
Concurrently, the company also announced initial results from the ongoing dose-escalation stage of QUARTZ-101, a phase I study evaluating XL102, a potent, selective, irreversible and orally bioavailable small molecule cyclin-dependent kinase 7 (CDK7) inhibitor, in patients with advanced solid tumors.
The phase I open-label dose escalation and cohort expansion study is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity and effect on biomarkers of XL102 administered alone and in multiple combination regimens in up to 298 patients with advanced solid tumors. Preclinical data on the candidate showed anti-proliferative activity and an ability to induce cell death across various cancer cell lines.
QUARTZ-101 is enrolling patients with solid tumors that are confirmed to be inoperable, locally advanced, metastatic or recurrent. The first phase is a dose-escalation stage to determine the maximum tolerable dose and/or recommended oral dose of XL102 as a single agent and in combination therapy. XL102 will be evaluated in patients with certain types of ovarian, breast and prostate cancers in the subsequent cohort-expansion stage.
Exelixis’ shares have lost 9.7% in the year so far compared with the
industry
’s decline of 17.4%.
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Cabometyx is a tablet formulation of cabozantinib approved for treating patients with advanced renal cell carcinoma (RCC) and patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar.
The approval of Cabometyx for patients with advanced RCC as a first-line treatment in combination with
Bristol Myers’
BMY
Opdivo (nivolumab) has fueled sales of the drug.
Bristol-Myers’ Opdivo is one of the leading revenue generators for 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.
The pipeline progress has been encouraging and the company’s efforts to expand its portfolio will reduce dependence on its lead drug.
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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