(IN BRIEF) Roche has released positive long-term follow-up data from the Phase III KATHERINE study, evaluating Kadcyla® (trastuzumab emtansine) as adjuvant therapy for people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant treatment. The study revealed a statistically significant and clinically meaningful improvement in overall survival (OS) with Kadcyla compared to Herceptin®. At the 7-year landmark, OS rates were 89.07% with Kadcyla and 84.37% with Herceptin. Kadcyla also maintained its benefit in invasive disease-free survival and reduced the risk of disease recurrence or death by 46%. The safety profile of Kadcyla remained consistent with previous findings. These results signify a significant advancement in treating HER2-positive early breast cancer, offering a chance for better outcomes for patients.
(PRESS RELEASE) BASEL, December 9, 2023 – /EuropaWire/ – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced positive long-term follow-up data from the pivotal Phase III KATHERINE study in people with HER2-positive Cancer early stage breast cancer (eBC) that has residual invasive disease after neoadjuvant treatment (before surgery). A statistically and clinically significant improvement in overall survival (OS), a secondary endpoint, was observed with adjuvant (post-surgical) Kadcyla® (trastuzumab emtansine) compared to Herceptin® (trastuzumab): 7-year time point, OS rates were 89. 07% and 84. 37% with Kadcyla and Herceptin, respectively (hazard ratio [HR] = 0. 66, 95% CI: (0. 51, 0. 87), p value = 0 . 0027). 2 The data also show that invasive disease-free survival (endpoint number one) was maintained in the past. 2 Kadcyla reduced the threat of disease recurrence or death regardless of the cause by 46 % compared to Herceptin (HR=0. 54, 95% CI: (0. 44, 0. 66), p-value <0. 0001), reinforcing the effects of KATHERINE's number one research. 2 . 3 The protection profile of Kadcyla was consistent with past effects and no new protective signals were identified. 2
“We are thrilled that Kadcyla is able to offer others with early, misdiagnosed HER2-positive breast cancer the chance to live longer and without recurrence of the disease,” said Levi Garraway, M. D. , Ph. D. , chief medical officer and chief medical officer at Roche. Chief Medical Officer. Responsible for Global Product Development. The ultimate goal of early-stage breast cancer treatment is to maximize the chances of recovery, and these findings are a step forward for these patients. “
“Thanks to remarkable advances in diagnosis and treatment, more women than ever survive an initial diagnosis of HER2-positive breast cancer at an early stage. However, in other people at higher risk for disease, recurrence and survival in the long term they remain a challenge,” said Prof. Dr. Sibylle Loibl, President of the German Breast Group (GBG), principal investigator of KATHERINE. “With these new data, Kadcyla is the first targeted treatment to demonstrate significant survival and gain benefits in other people with early HER2-positive breast cancer with residual invasive disease after neoadjuvant treatment.
The KATHERINE study was conducted in collaboration with GBG and NSABP Foundation, Inc. The comprehensive insights will be presented as an oral presentation at the 2023 Breast Cancer Symposium in San Antonio on Friday, Dec. 8.
Kadcyla is approved in 113 countries and is the popular treatment for people with HER2-positive eBC with residual invasive disease after neoadjuvant therapy, building on previous positive effects of KATHERINE that showed Kadcyla halved the risk of disease recurrence or death for Herceptin. 3 In addition, after 3 years, 88. 3% of other people treated with Kadcyla did not have a recurrence of their breast cancer, compared to 77. 0% of those treated with Herceptin, an absolute improvement of 11. 3%. 3
Breast cancer is the most commonly diagnosed type of cancer, with a significant societal impact. 4 Approximately one in five people with breast cancer will be HER2-positive, a specifically competitive form of the disease. 5 The purpose of eBC treatment is to provide others with the maximum productive chance of recovery. 6 While we get closer to that goal with each breakthrough, Many other people still have a long-term recurrence of the disease, and more personalized treatment features are needed to decrease this risk and help others live longer. 7,8
Kadcyla is also approved for the treatment of people with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane.
The number one endpoint of the study is invasive disease-free survival (iDFS), which, in this study, is explained as the time elapsed since randomization without recurrence of invasive breast cancer or death from any cause. 9 Secondary endpoints include DFS and overall survival. . 9
Roche has developed cutting-edge medicines, adding patient-centric formulations, that have helped reshape the treatment of HER2-positive breast cancer: Herceptin® (trastuzumab) in intravenous and subcutaneous formulations, Perjeta® (pertuzumab), Kadcyla® (trastuzumab emtansine), and PHESGO® (pertuzumab, trastuzumab, and hyaluronidase-zzxf). 12,13,14 Eligibility for treatment with Roche’s HER2-targeted medicines is decided by diagnostic testing, that identify others who are more likely to benefit from those drugs early. in his illness.
Our targeted medicines Herceptin® (trastuzumab), Perjeta® (pertuzumab), PHESGO® (pertuzumab, trastuzumab and hyaluronidase-zzxf), Kadcyla® (trastuzumab emtansine), and Tecentriq® (atezolizumab) continue to reshape the treatment of early-stage patients with HER2-positive and triple-negative complex breast cancers, and through our clinical programs, we hope to bring new combinations of treatments to others with breast cancer. obtaining better results. 12,13,14,15Array
Thanks to our efforts to take a long-term approach to everything we do, Roche has been named one of the most sustainable corporations in the pharmaceutical industry through the Dow Jones Sustainability Indices for the thirteenth consecutive year. This difference also reflects our efforts to access health care. in collaboration with local partners in each country where we work.
Genentech, in the United States, is a company wholly owned by the Roche Group. Roche is the majority shareholder of Chugai Pharmaceutical, Japan.
For information, visit www. roche. com.
All trademarks used or discussed in this press release are by law.
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