ALAMEDA, CA, USA I December 08, 2022 IExelixis, Inc. (Nasdaq: EXEL) today announced that the CONTACT-01 study did not meet its primary endpoint of overall survival at the final analysis. CONTACT-01 is a phase 3 trial evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) 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 safety profile of the combination of cabozantinib and atezolizumab observed in the trial was consistent with the known safety profiles for each single agent, and no new safety signals were identified. Detailed findings from CONTACT-01 will be submitted for presentation at a future medical meeting.
About CONTACT-01
CONTACT-01 is a global, multicenter, randomized, phase 3, open-label study that 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 study enrolled patients with both squamous and non-squamous NSCLC who progressed during or following anti-PD-1/PD-L1 therapy administered either concurrently or sequentially with chemotherapy. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, objective response rate and duration of response. Results from cohort 7 of the phase 1b COSMIC-021 trial informed the CONTACT-01 trial design. CONTACT-01 was sponsored by Roche and co-funded by Exelixis. Both Ipsen and Takeda Pharmaceutical Company Limited (Takeda) opted in to participate in the trial and are contributing to the funding for this study under the terms of the companies’ respective collaboration agreements with Exelixis. More information about the trial is available at ClinicalTrials.gov.
About NSCLC
Lung cancer is a leading cause of cancer death globally.1 Every year, almost 1.8 million people die from the disease.1 In the U.S., lung cancer is the second most common type of cancer, with more than 236,000 new cases expected to be diagnosed in 2022.2 The majority (84%) of lung cancer cases are NSCLC.3 The overall five-year survival rate for patients with NSCLC is 26%, but that rate falls to just 7% for those with advanced or metastatic disease.4 More than half of lung cancer cases are diagnosed when metastatic.5
Cancer immunotherapy alone or in combination with platinum-containing chemotherapy is a standard of care treatment in first- and second-line NSCLC.6 However, people who progress after this initial therapy have limited treatment options and survival outcomes remain poor.5,6,7
About CABOMETYX® (cabozantinib)
In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced renal cell carcinoma (RCC); for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib; for patients with advanced RCC as a first-line treatment in combination with nivolumab; and for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan. In 2017, Exelixis granted exclusive rights to Takeda for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
CABOMETYX in combination with atezolizumab is not indicated as a treatment for NSCLC.
Please see accompanying full Prescribing Information https://www.cabometyx.com/downloads/CABOMETYXUSPI.pdf.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
About Exelixis
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
1 Lung. Global Cancer Observatory website. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed December 2022.
2 Key Statistics for Lung Cancer. American Cancer Society website. Available at: https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Accessed December 2022.
3 What is Lung Cancer? American Cancer Society website. Available at: https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed December 2022.
4 Lung Cancer – Non-small Cell: Statistics. Cancer.Net website. Available at: https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics. Accessed December 2022.
5 Cancer Stat Facts: Lung and Bronchus Cancer. SEER website. Available at: https://seer.cancer.gov/statfacts/html/lungb.html. Accessed December 2022.
6 Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version. NCI website. Available at: https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq#_48457. Accessed December 2022.
7 Treatment Choices for Non-Small Cell Lung Cancer, by Stage. ACS website. Available at: https://www.cancer.org/cancer/lung-cancer/treating-non-small-cell/by-stage.html. Accessed December 2022.
SOURCE: Exelixis
Post Views: 76
ALAMEDA, CA, USA I December 08, 2022 IExelixis, Inc. (Nasdaq: EXEL) today announced that the CONTACT-01 study did not meet its primary endpoint of overall survival at the final analysis. CONTACT-01 is a phase 3 trial evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) 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 safety profile of the combination of cabozantinib and atezolizumab observed in the trial was consistent with the known safety profiles for each single agent, and no new safety signals were identified. Detailed findings from CONTACT-01 will be submitted for presentation at a future medical meeting.
About CONTACT-01
CONTACT-01 is a global, multicenter, randomized, phase 3, open-label study that 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 study enrolled patients with both squamous and non-squamous NSCLC who progressed during or following anti-PD-1/PD-L1 therapy administered either concurrently or sequentially with chemotherapy. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, objective response rate and duration of response. Results from cohort 7 of the phase 1b COSMIC-021 trial informed the CONTACT-01 trial design. CONTACT-01 was sponsored by Roche and co-funded by Exelixis. Both Ipsen and Takeda Pharmaceutical Company Limited (Takeda) opted in to participate in the trial and are contributing to the funding for this study under the terms of the companies’ respective collaboration agreements with Exelixis. More information about the trial is available at ClinicalTrials.gov.
About NSCLC
Lung cancer is a leading cause of cancer death globally.1 Every year, almost 1.8 million people die from the disease.1 In the U.S., lung cancer is the second most common type of cancer, with more than 236,000 new cases expected to be diagnosed in 2022.2 The majority (84%) of lung cancer cases are NSCLC.3 The overall five-year survival rate for patients with NSCLC is 26%, but that rate falls to just 7% for those with advanced or metastatic disease.4 More than half of lung cancer cases are diagnosed when metastatic.5
Cancer immunotherapy alone or in combination with platinum-containing chemotherapy is a standard of care treatment in first- and second-line NSCLC.6 However, people who progress after this initial therapy have limited treatment options and survival outcomes remain poor.5,6,7
About CABOMETYX® (cabozantinib)
In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced renal cell carcinoma (RCC); for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib; for patients with advanced RCC as a first-line treatment in combination with nivolumab; and for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan. In 2017, Exelixis granted exclusive rights to Takeda for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
CABOMETYX in combination with atezolizumab is not indicated as a treatment for NSCLC.
Please see accompanying full Prescribing Information https://www.cabometyx.com/downloads/CABOMETYXUSPI.pdf.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
About Exelixis
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
1 Lung. Global Cancer Observatory website. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed December 2022.
2 Key Statistics for Lung Cancer. American Cancer Society website. Available at: https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Accessed December 2022.
3 What is Lung Cancer? American Cancer Society website. Available at: https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed December 2022.
4 Lung Cancer – Non-small Cell: Statistics. Cancer.Net website. Available at: https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics. Accessed December 2022.
5 Cancer Stat Facts: Lung and Bronchus Cancer. SEER website. Available at: https://seer.cancer.gov/statfacts/html/lungb.html. Accessed December 2022.
6 Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version. NCI website. Available at: https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq#_48457. Accessed December 2022.
7 Treatment Choices for Non-Small Cell Lung Cancer, by Stage. ACS website. Available at: https://www.cancer.org/cancer/lung-cancer/treating-non-small-cell/by-stage.html. Accessed December 2022.
SOURCE: Exelixis
Post Views: 76
