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Exelixis Inc. reports developments from its oncology business, including commercial performance for the cabozantinib franchise and clinical and regulatory updates across cancer programs. The company discovers, develops and commercializes cancer medicines, with CABOMETYX® (cabozantinib) as its flagship commercial product and COMETRIQ® also part of its cabozantinib portfolio.
Recurring updates include quarterly financial results, product revenue trends, financial guidance, pipeline milestones and investor conference presentations. Exelixis also discusses zanzalintinib, an investigational oral kinase inhibitor, and a broader pipeline of small molecules and biotherapeutics targeting additional tumor types and indications.
Exelixis, Inc. (Nasdaq: EXEL) announced that the COSMIC-313 trial, evaluating cabozantinib (CABOMETYX), nivolumab (OPDIVO), and ipilimumab (YERVOY) for untreated advanced renal cell carcinoma, has completed enrollment. The trial enrolled about 840 patients at 180 sites worldwide. Primary endpoints include progression-free survival, with additional endpoints focusing on overall survival. This marks a significant advancement in understanding the potential benefits of the triplet therapy in kidney cancer treatment.
Exelixis announced a collaboration with Merck KGaA and Pfizer for the STELLAR-001 clinical trial, evaluating XL092, a next-generation tyrosine kinase inhibitor (TKI), in combination with avelumab, an anti-PD-L1 immune checkpoint inhibitor, for treating advanced urothelial carcinoma. The trial aims to assess safety and tolerability while potentially adding three expansion cohorts. XL092 targets various kinases implicated in cancer progression, and early preclinical results indicated enhanced efficacy when combined with immunotherapy. This partnership aims to improve outcomes for patients with challenging cancers.
Exelixis (Nasdaq: EXEL) has formed an exclusive license agreement with WuXi Biologics to advance its oncology biologics pipeline. The deal includes an upfront payment for a panel of monoclonal antibodies aimed at tumor-targeting biologics. This collaboration follows the FDA's fourth approval of Exelixis' flagship product, CABOMETYX, earlier this year. Exelixis aims to leverage WuXi Bio's technology and expertise to enhance its biotherapeutics portfolio, thus improving cancer treatment options.
Exelixis (NASDAQ: EXEL) announced that its partner Ipsen has obtained a positive opinion from the CHMP for CABOMETYX® (cabozantinib) in combination with OPDIVO® (nivolumab) as a first-line treatment for advanced kidney cancer. Following the FDA approval in the U.S., this recommendation marks progress towards making this treatment available in Europe. CABOMETYX is already approved in the EU for various conditions, and its combination with OPDIVO has shown promising results, significantly improving patient outcomes in clinical trials.
Exelixis, Inc. (Nasdaq: EXEL) announced that CEO Michael M. Morrissey, Ph.D., will take part in several virtual investor conferences in March 2021. Key presentations include:
- Cowen 41st Annual Healthcare Conference on March 1 at 2:40 PM EST.
- Barclays Global Healthcare Conference on March 9 at 11:30 AM EST.
- Oppenheimer 31st Annual Healthcare Conference on March 16 at 11:20 AM EDT.
Investors can access the webcasts on the Exelixis website, with replays available for 14 days.
Exelixis, Inc. (NASDAQ: EXEL) announced that the FDA has granted Breakthrough Therapy Designation for cabozantinib (CABOMETYX®) as a treatment for differentiated thyroid cancer (DTC) in patients who are radioactive iodine-refractory. This designation accelerates drug development for serious conditions. Preliminary data from the phase 3 COSMIC-311 trial showed cabozantinib significantly improved progression-free survival, with a 78% reduction in disease progression risk (HR 0.22; p0.0001) compared to placebo. Exelixis plans to submit a regulatory application in 2021.
Exelixis, Inc. (Nasdaq: EXEL) announced that President and CEO Michael M. Morrissey, Ph.D., will participate in a fireside chat at the SVB Leerink 10th Annual Global Healthcare Conference on February 26, 2021, at 1:00 PM EST. Due to the COVID-19 pandemic, the event will be virtual. Investors can access the webcast through the Exelixis website and are advised to join 15 minutes early. Exelixis is known for its oncology-focused biotechnology efforts, having developed four products and recognized for its rapid growth.
Exelixis announced positive phase 2 results for CABOMETYX® (cabozantinib) in treating metastatic papillary renal cell carcinoma (PRCC), outperforming sunitinib, the preferred therapy. The S1500 trial revealed a median progression-free survival (PFS) of 9.0 months for CABOMETYX compared to 5.6 months for sunitinib, with a statistically significant hazard ratio of 0.60 (p=0.019). Additionally, the objective response rate (ORR) was significantly higher at 23% for CABOMETYX versus 4% for sunitinib (p=0.010). Findings will be presented at ASCO GU on February 13, 2021, and published in The Lancet.
Exelixis reported positive final data from a phase 1 trial evaluating cabozantinib combined with nivolumab or nivolumab plus ipilimumab in patients with refractory metastatic genitourinary tumors. The trial showed an overall response rate (ORR) of 38%, with a complete response rate of 11.1% across 108 evaluable patients. Notably, the ORR was 62.5% in patients with metastatic renal cell carcinoma and 42.4% for metastatic urothelial carcinoma. The study supports further research into cabozantinib combinations, aiming to provide enhanced treatment options for challenging GU malignancies.
Exelixis, Inc. (Nasdaq: EXEL) reported 2020 financial results, highlighting total revenues of $987.5 million, a 2% increase from 2019. The fourth quarter alone brought in $270.1 million in revenues. While net product revenues for the year decreased to $741.6 million, collaboration revenues rose significantly to $246.0 million. The company's GAAP net income was $111.8 million, or $0.36 per share, down from $321 million in 2019. Exelixis anticipates 2021 revenues between $1.15 billion and $1.25 billion, fueled by ongoing regulatory efforts and pipeline advancements.