SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today 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® (ado-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 The safety profile of Kadcyla was consistent with previous findings and no new safety signals were identified. 'The ultimate goal of treating early breast cancer is to maximize the chance of cure, and these results signify an important step forward for these patients.' “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., Genentech's chief medical officer and head of Global Product Development. “The ultimate goal of treating early breast cancer is to maximize 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 being presented as an oral presentation at the 2023 San Antonio Breast Cancer Symposium on Friday, December 8. 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 personalized treatment options are needed to reduce this risk and help people live longer. About the KATHERINE Study
KATHERINE is an international, multi-center, two-arm, randomized, 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. 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 which, in this study, is defined as the time from randomization free from invasive breast cancer recurrence or death from any cause. Secondary endpoints include DFS and overall survival. Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com. Important Safety Information
Most important safety information about Kadcyla Receiving Kadcyla during pregnancy can result in the death of an unborn baby and birth defects. Birth control should be used while receiving Kadcyla and for seven months after a patient’s last dose of Kadcyla. If a patient thinks she may be pregnant, she should contact her healthcare provider immediately.
If a patient is exposed to Kadcyla during pregnancy or becomes pregnant within seven months following her last dose of Kadcyla, she is encouraged to report Kadcyla exposure to Genentech by calling (888) 835-2555. If a male patient has a female partner that could become pregnant, birth control should be used during treatment and for four months following his last dose of Kadcyla. A patient should not breastfeed during treatment and for seven months after the last dose of Kadcyla. A patient should contact their doctor right away if they experience symptoms associated with these side effects.
Additional possible serious side effects of Kadcyla Kadcyla may cause lung problems, including inflammation of the lung tissue, which can be life-threatening. Signs of lung problems may include trouble breathing, cough, tiredness, and fluid in the lungs. Infusion-related reactions
Symptoms of an infusion-related reaction may include one or more of the following: the skin getting hot or red (flushing), chills, fever, trouble breathing, low blood pressure, wheezing, tightening of the muscles in the chest around the airways, or a fast heartbeat. A patient’s doctor will monitor the patient for infusion-related reactions. Kadcyla can cause life-threatening bleeding. Taking Kadcyla with other medications used to thin the blood (antiplatelet) or prevent blood clots (anticoagulation) can increase the risk of bleeding. A patient’s doctor should provide additional monitoring if the patient is taking one of these other drugs while on Kadcyla. Even when blood thinners are not also being taken, life-threatening bleeding may occur with Kadcyla. Low platelet count may happen during treatment with Kadcyla. Platelets help the blood to clot. Signs of low platelets may include easy bruising, bleeding, and prolonged bleeding from cuts. In mild cases there may not be any symptoms. Symptoms of nerve damage may include numbness and tingling, burning or sharp pain, sensitivity to touch, lack of coordination, muscle weakness, or loss of muscle function. Skin reactions around the infusion site
Kadcyla may leak from the vein or needle and cause reactions such as redness, tenderness, skin irritation, or pain or swelling at the infusion site. If this happens, it is more likely to happen within 24 hours of the infusion. Most common side effects of Kadcyla Pain that affects the bones, muscles, ligaments, and tendons Pain that affects the bones, muscles, ligaments, and tendons Patients are encouraged to report side effects to Genentech and the FDA. Patients may contact Genentech by calling (888) 835-2555. Patients may contact the FDA by visiting http://www.fda.gov/medwatch or calling (800) FDA-1088. Please click here for Kadcyla full Prescribing Information, including Most Important Safety Information, for additional Important Safety Information. Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy).
Patients are selected for therapy based on an FDA-approved test for Herceptin. *High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3. Patients are selected for therapy based on an FDA-approved test for Herceptin. Important Safety Information
Not all people have serious side effects, but side effects with Herceptin therapy are common. Although some people may have a life-threatening side effect, most do not.
A patient’s doctor will stop treatment if any serious side effects occur.
Herceptin is not for everyone. A patient should be sure to contact their doctor if they are experiencing any of the following: These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. A patient’s doctor will check for signs of heart problems before, during, and after treatment with Herceptin. INFUSION REACTIONS, including:
Feeling sick to your stomach (nausea) These signs usually happen within 24 hours after receiving Herceptin. A patient should be sure to contact their doctor if they:
Are a woman who could become pregnant, or may be pregnant
Have any signs of SEVERE LUNG PROBLEMS, including:
Severe shortness of breath
Fluid in or around the lungs
Weakening of the valve between the heart and the lungs
Not enough oxygen in the body
A patient’s doctor may check for signs of severe lung problems when he or she examines the patient.
Have LOW WHITE BLOOD CELL COUNTS
Low white blood cell counts can be life-threatening. Low white blood cell counts were seen more often in patients receiving Herceptin plus chemotherapy than in patients receiving chemotherapy alone. A patient’s doctor may check for signs of low white blood cell counts when he or she examines the patient.
Feeling sick to your stomach (nausea) Low white and red blood cell counts
A patient should contact their doctor immediately if they have any of the side effects listed above.
Patients are encouraged to report side effects to Genentech and the FDA. Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555. Please see the Herceptin full Prescribing Information for additional Important Safety Information, including most serious side effects, at http://www.herceptin.com.