Exelixis Announces Final Results from Phase 3 COSMIC-311 Pivotal Trial of CABOMETYX? in Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer Presented
ALAMEDA, Calif.--(BUSINESS WIRE)--Sep. 20, 2021--?Exelixis, Inc.?(Nasdaq: EXEL) today announced final results from the phase 3 COSMIC-311 pivotal trial of CABOMETYX??(cabozantinib) in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer (DTC). Following a previous?announcement?that the trial met one of the two primary endpoints of significant improvement versus placebo in progression-free survival (PFS) assessed by blinded independent radiology committee (BIRC; p<0.0001), the results of the final analysis are being presented during the Mini Oral Session ? NETs and Endocrine Tumours at?5:30 p.m. CEST?on?Monday, September 20?at the 2021?European Society of Medical Oncology (ESMO) Congress?(LBA67). At a median follow-up of 10.1 months, the significant improvement in PFS with CABOMETYX was maintained, with consistent benefit in subgroups based on prior treatment.
?Given the urgent need for new treatments for differentiated thyroid cancer, I?m encouraged to see that cabozantinib benefited patients in COSMIC-311 both at a longer follow-up and across prior therapy subgroups,? said?Jaume Capdevila, M.D., Ph.D., Medical Oncologist at Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO),?Barcelona, and a COSMIC-311 study investigator. ?These strong findings, which formed the basis for the recent?U.S.?FDA approval, further support cabozantinib as an important new treatment option for patients with radioactive iodine-refractory differentiated thyroid cancer who previously had no standard of care following disease progression on anti-VEGFR therapy.?
At a median follow-up of 10.1 months, CABOMETYX reduced the risk of disease progression or death versus placebo (hazard ratio [HR]: 0.22; 96% confidence interval [CI]: 0.15?0.32) in the intent-to-treat (ITT) population. Median PFS as assessed by BIRC was 11.0 months for patients treated with CABOMETYX (n=170) compared with 1.9 months for patients treated with placebo (n=88). Subgroup analyses demonstrated that CABOMETYX improved PFS versus placebo irrespective of prior exposure to lenvatinib and/or sorafenib:
- Prior sorafenib/no lenvatinib: median PFS was 16.6 months for patients treated with CABOMETYX (n=63) compared with 3.2 months for placebo (n=33) (HR: 0.13; 95% CI: 0.06?0.26).
- Prior lenvatinib/no sorafenib: median PFS was 5.8 months for patients treated with CABOMETYX (n=68) compared with 1.9 months for placebo (n=34) (HR: 0.28; 95% CI: 0.16?0.48).
- Prior sorafenib and lenvatinib: median PFS was 7.6 months for patients treated with CABOMETYX (n=39) compared with 1.9 months for placebo (n=21) (HR: 0.27; 95% CI: 0.13?0.54).
Exelixis, the?Exelixis?logo, CABOMETYX, COMETRIQ and COTELLIC are registered?U.S.?trademarks of?Exelixis. MINNEBRO is a registered trademark of Daiichi Sankyo Company, Limited.
1?American Cancer Society. About Thyroid Cancer. Available at:?https://www.cancer.org/cancer/thyroid-cancer/about.html. Accessed?September 2021. 2?Cooper DS, et al. 2009.?Revised American Thyroid Association?management guidelines for patients with thyroid nodules and differentiated thyroid cancer:?The American Thyroid Association?(ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer.?Thyroid. 19:1167?1214. 3?Worden F. 2014. Treatment strategies for radioactive iodine-refractory differentiated thyroid cancer.?Ther Adv Med Oncol. 6:267?279. 4?Fugazzola L, et al. 2019. 2019 European Thyroid Association Guidelines for the Treatment and Follow-Up of Advanced Radioiodine-Refractory Thyroid Cancer.?Eur Thyroid J. 8:227?245. 5?Pacini F, et al. 2012. Radioactive iodine-refractory differentiated thyroid cancer: unmet needs and future directions.?Expert Rev Endocrinol Metab. 7:541?554. 6?Durante C, et al. 2006. Long-term outcome of 444 patients with distant metastases from papillary and follicular thyroid carcinoma: benefits and limits of radioiodine therapy.?J Clin Endocrinol Metab. 91:2892?2899.View source version on?businesswire.com:?https://www.businesswire.com/news/home/20210920005331/en/
Investors: Susan Hubbard EVP, Public Affairs and Investor Relations Exelixis, Inc. (650) 837-8194 shubbard@exelixis.com Media: Lindsay Treadway Executive Director, Public Affairs and Advocacy Relations Exelixis, Inc. (650) 837-7522 ltreadway@exelixis.com Source:?Exelixis, Inc.