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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 reported approximately $1.08 billion in preliminary U.S. net product revenues for 2021, driven mainly by the cabozantinib franchise. The company estimates its 2022 net product revenues between $1.325 billion and $1.425 billion. With ongoing phase 3 pivotal trials for cabozantinib and the initiation of pivotal trials for XL092, Exelixis aims to grow its oncology portfolio. The company plans to expand its development team and operations, including a new facility on the East Coast. Financial guidance for 2022 includes R&D expenses of $725 million to $775 million and SG&A expenses of $400 million to $450 million.
Exelixis has amended its May 2019 agreement with Iconic Therapeutics, gaining full rights to the anti-tissue factor antibody used in XB002 and oncology-specific rights to additional antibodies. In exchange for a one-time payment of $55 million, Exelixis can use the antibody in various applications, including drug conjugates. The company aims to develop a promising franchise targeting cancer therapy, with plans to report initial data from the ongoing XB002 clinical trial later this year.
Exelixis, Inc. announced the completion of patient enrollment for CONTACT-03, a pivotal Phase 3 trial assessing the efficacy and safety of cabozantinib combined with atezolizumab versus cabozantinib alone in renal cell carcinoma patients who had progressed post immune checkpoint inhibitor treatment. The trial enrolled 523 patients, randomized to two arms, with primary endpoints focused on progression-free survival and overall survival. Initial results are anticipated upon data maturation, offering insights into treatment sequencing for advanced kidney cancer.
Exelixis (NASDAQ: EXEL) will present a corporate overview at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 5:15 PM ET. CEO Michael M. Morrissey, Ph.D., will lead the presentation. Interested parties can access the webcast through www.exelixis.com and should connect 15 minutes early for any necessary software downloads. A replay will be available for 14 days post-event. Exelixis is focused on developing oncology therapies and has four products on the market, including CABOMETYX and COTELLIC.
Exelixis has appointed Dr. Vicki L. Goodman as Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer. Dr. Goodman brings over 20 years of oncology experience, previously serving at Merck, Bristol Myers Squibb, and GlaxoSmithKline. Her role will involve leading Exelixis' clinical and medical affairs, particularly focusing on the ongoing CABOMETYX trials and the development of new therapeutics. She will also spearhead the company's expansion efforts on the East Coast, enhancing collaboration and growth opportunities.
Exelixis, Inc. (Nasdaq: EXEL) announced the election of Jackie Wright to its Board of Directors, effective December 16, 2021. With extensive experience in technology and digital transformation from her roles at Microsoft, BP, and General Electric, Wright aims to enhance Exelixis' growth in the oncology sector. Her leadership is expected to drive digital initiatives and support the company’s mission to improve cancer treatment outcomes.
Exelixis, Inc. has initiated the dose-escalation stage of the STELLAR-002 trial, exploring XL092, a next-generation tyrosine kinase inhibitor, in combination with immuno-oncology therapies for advanced cancers. Collaborating with Bristol-Myers Squibb and Nektar Therapeutics, the trial aims to assess safety and efficacy among patients with advanced solid tumors. The study will focus on renal cell carcinoma, urothelial carcinoma, and metastatic castration-resistant prostate cancer, with primary endpoints including objective response rates and progression-free survival.
Exelixis plans to submit a supplemental New Drug Application (sNDA) to the FDA in early 2022 after presenting the first analysis of the COSMIC-312 phase 3 trial. This trial assesses the efficacy of cabozantinib with atezolizumab compared to sorafenib in treating advanced hepatocellular carcinoma (HCC). At 15.8 months follow-up, cabozantinib plus atezolizumab showed a 37% reduction in disease progression risk (PFS) versus sorafenib, though overall survival (OS) results were not statistically significant (HR: 0.90). The trial continues as planned for final OS analysis, anticipated in early 2022.
Exelixis has completed enrollment for its global phase 3 pivotal trial, CONTACT-01, assessing cabozantinib combined with atezolizumab in patients with metastatic non-small cell lung cancer (NSCLC) previously treated with an immune checkpoint inhibitor. The study includes 366 patients randomly assigned to either treatment or control arms, with overall survival as the primary endpoint. Following initial promising results from the COSMIC-021 trial, the company is optimistic about this combination and plans to share top-line results upon data maturity.
Exelixis (NASDAQ: EXEL) announced upcoming participation in several virtual investor conferences throughout November and December 2021. The management team will present at events including:
- BMO Biopharma Spotlight Series on November 8 at 12:10 p.m. ET
- Credit Suisse 30th Annual Virtual Healthcare Conference on November 10 at 1:50 p.m. ET
- Stifel 2021 Healthcare Conference on November 16 at 4:40 p.m. ET
- Piper Sandler 33rd Annual Virtual Healthcare Conference on November 22, available on demand
- Evercore ISI 4th Annual HealthConX Virtual Conference on December 1 at 11:45 a.m. ET
Webcast links can be accessed via Exelixis' website.