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ALAMEDA, Calif. - Exelixis, Inc. (NASDAQ:EXEL), a biopharmaceutical company with robust financials including a 96.59% gross margin and over $2.2 billion in trailing twelve-month revenue, announced that its experimental drug combination of zanzalintinib with atezolizumab demonstrated improved overall survival in patients with previously treated metastatic colorectal cancer compared to standard treatment.
The phase 3 STELLAR-303 trial showed the combination reduced the risk of death by 20% compared to regorafenib, with median overall survival reaching 10.9 months versus 9.4 months in the intention-to-treat population. The findings were presented at the European Society for Medical Oncology Congress and published in The Lancet. According to InvestingPro analysis, Exelixis maintains a strong financial health score of 3.68 (rated as "GREAT"), suggesting robust capability to fund its drug development pipeline.
Survival benefits were consistent across subgroups, including patients with different geographic regions, RAS status, liver involvement, and prior treatment history. The 12-month survival rate was 46% for patients receiving the combination therapy compared to 38% for those on regorafenib.
"STELLAR-303 is the first immunotherapy-based phase 3 trial that demonstrated improved overall survival with a differentiated kinase inhibitor compared to a standard of care in this patient population," said Dr. Anwaar Saeed, lead investigator of the trial.
While the trial showed a trend toward improved progression-free survival with the combination (3.7 months versus 2.0 months), statistical superiority could not be claimed due to the study’s testing strategy.
The safety profile was consistent with previous observations. Grade 3/4 treatment-related adverse events occurred in 59% of patients receiving the combination versus 37% of patients on regorafenib, with hypertension being the most common serious side effect.
Exelixis plans to complete its first new drug application submission for zanzalintinib in the U.S. in 2025, according to the company’s press release statement.
Colorectal cancer is the third most common cancer and second leading cause of cancer-related deaths in the U.S., with approximately 154,000 new cases expected in 2025. With a current ratio of 3.51 and minimal debt-to-equity of 0.09, Exelixis appears well-positioned to capitalize on this market opportunity. InvestingPro subscribers can access 8 additional key insights and a comprehensive Pro Research Report that details the company’s market position and growth potential.
In other recent news, Exelixis, Inc. reported promising results from its phase 3 CABINET trial, where its drug CABOMETYX (cabozantinib) showed an 81% reduction in the risk of disease progression or death in patients with advanced lung or thymic neuroendocrine tumors. The median progression-free survival for patients treated with CABOMETYX was 8.2 months, compared to 2.7 months for those on a placebo. As the European Society for Medical Oncology conference approaches, Truist Securities reiterated its Buy rating on Exelixis, maintaining a price target of $49.00. Meanwhile, UBS has adjusted its price target for Exelixis to $35.00, citing concerns about the upcoming Phase 3 STELLAR data for the company’s Zanza pipeline program. Barclays initiated coverage on Exelixis with an Equalweight rating and a $40.00 price target, projecting steady growth for cabozantinib until its patent expiration in 2029. Additionally, Goldman Sachs initiated coverage with a Buy rating and a $47.00 price target, highlighting the potential of zanzalintinib to compensate for revenue losses once Cabometyx loses exclusivity later in the decade.
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