Roche announces positive results from phase III KATHERINE study in people with HER2-positive eBC with residual invasive disease after neoadjuvant treatment

Roche announced positive long-term follow-up data from the pivotal, phase III KATHERINE study in people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant (before surgery) treatment. A statistically significant and clinically meaningful improvement in overall survival (OS), a secondary endpoint, was observed with adjuvant (post-surgery) Kadcyla (trastuzumab emtansine) compared to Herceptin (trastuzumab): at the 7-year landmark 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).

Data also show that the previously reported invasive disease-free survival (primary endpoint) benefit is maintained. Kadcyla reduced the risk of disease recurrence or death from any cause by 46% compared to Herceptin (HR=0.54, 95% CI: (0.44, 0.66), p-value <0.0001), strengthening the results of the primary analysis of KATHERINE. The safety profile of Kadcyla was consistent with previous findings and no new safety signals were identified.

“We are pleased that Kadcyla could offer people with HER2-positive early breast cancer with a particularly poor prognosis a chance to live longer and without recurrence of their disease,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development. “The ultimate goal of treating early breast cancer is to maximise the chance of cure, and these results signify an important step forward for these patients.”

"Thanks to remarkable advances in diagnostics and treatment, more women are surviving an initial diagnosis of HER2-positive early-stage breast cancer than ever before. However, in those with higher risk disease, recurrence and long-term survival have remained a challenge,” said Prof. Dr. Sibylle Loibl, Chair of the German Breast Group (GBG), Principal Investigator of KATHERINE. “With these new data, Kadcyla is the first targeted therapy to demonstrate a significant survival benefit in people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment."

The KATHERINE study has been conducted in collaboration with the GBG and NSABP Foundation, Inc. Full data are presented as an oral presentation at the 2023 San Antonio Breast Cancer Symposium on Friday 08 December.

Kadcyla is approved in 113 countries and is the standard of care for people with HER2-positive eBC with residual invasive disease following neoadjuvant treatment, based on previous positive results from KATHERINE that showed Kadcyla cut the risk of disease recurrence or death by half versus Herceptin. Additionally, at three years, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an absolute improvement of 11.3%.

Breast cancer is the most frequently diagnosed type of cancer, with major societal impact. Approximately one in five people with breast cancer will be HER2-positive, a particularly aggressive form of the disease. The goal in treating eBC is to provide people with the best chance for a cure. While we come closer to this goal with each advance, many people still have disease recurrence in the long-term and more personalised treatment options are needed to reduce this risk and help people live longer.

Kadcyla is also approved for the treatment of people with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane.

KATHERINE is an international, multi-centre, two-arm, randomised, open-label, phase III study evaluating the efficacy and safety of Kadcyla versus Herceptin as an adjuvant therapy in people with HER2-positive early-stage breast cancer who have residual invasive disease following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy.9 In KATHERINE, residual invasive disease was defined as the presence of invasive residual disease in tissue samples from breast and/or axillary nodes following neoadjuvant treatment. People who have residual invasive disease after neoadjuvant treatment generally have a worse prognosis than those without detectable disease at surgery.

The primary endpoint of the study is invasive disease-free survival (iDFS) which, in this study, is defined as the time from randomisation free from invasive breast cancer recurrence or death from any cause. Secondary endpoints include DFS and overall survival.

Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues. It combines two anti-cancer properties joined together by a stable linker: the HER2-targeting properties of trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1. Kadcyla is approved for the treatment of people with HER2-positive metastatic breast cancer (as of 2013) and HER2-positive early-stage breast cancer (as of 2019). Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.

Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early-stage and advanced HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients.

Roche has developed innovative medicines, including in patient-centric formulations, which have helped transform the treatment of HER2-positive breast cancer: Herceptin (trastuzumab) in both intravenous and subcutaneous formulations, Perjeta (pertuzumab), Kadcyla (trastuzumab emtansine) and Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease.

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