NSABP Foundation, Inc.

Phase III KATHERINE results reinforce Kadcyla as the standard of care for this population, with more than 82,000 people treated to date1,2Long-term data also showed continued benefit in invasive disease-free survival for adjuvant Kadcyla compared to Herceptin in this study2These data will be presented as an oral presentation at the 2023 San Antonio Breast Cancer Symposium and included in the official press programme Basel, 8 December 2023 - Roche (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® (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).2 Data also show that the previously reported invasive disease-free survival (primary endpoint) benefit is maintained.2 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.2,3 The safety profile of Kadcyla was consistent with previous findings and no new safety signals were identified.2 “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 being 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.1,3 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%.3 Breast cancer is the most frequently diagnosed type of cancer, with major societal impact.4 Approximately one in five people with breast cancer will be HER2-positive, a particularly aggressive form of the disease.5 The goal in treating eBC is to provide people with the best chance for a cure.6 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.7,8 Kadcyla is also approved for the treatment of people with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane. About the KATHERINE studyKATHERINE 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.9 People who have residual invasive disease after neoadjuvant treatment generally have a worse prognosis than those without detectable disease at surgery.10 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.9 Secondary endpoints include DFS and overall survival.9 About KadcylaKadcyla 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 DM1.11 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. About Roche’s medicines for HER2-positive breast cancerRoche 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.5 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).12,13,14 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. About Roche in breast cancerRoche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early-stage and advanced breast cancer, including triple-negative and hormone receptor-positive. Our targeted medicines Herceptin® (trastuzumab), Perjeta® (pertuzumab), PHESGO® (pertuzumab, trastuzumab, and hyaluronidase-zzxf), Kadcyla® (trastuzumab emtansine) and Tecentriq® (atezolizumab) are continuing to transform the treatment of early-stage and advanced HER2-positive and triple-negative breast cancers and, through our clinical programmes, we hope to bring new treatment combinations to people with breast cancer, ultimately improving outcomes.12,13,14,15 About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Roche data on file. [2] Loibl S, et al. Phase III study of adjuvant ado-trastuzumab emtansine vs trastuzumab for residual invasive HER2-positive early breast cancer after neoadjuvant chemotherapy and HER2-targeted therapy: KATHERINE final IDFS and updated OS analysis. Presented at: San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, Texas, USA. Abstract #GS03-12.[3] von Minckwitz G, et al. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019;380:617-28.[4] Arnold M, et al. Current and future burden of breast cancer: Global statistics for 2020 and 2040. Breast. 2022;66:15-23.[5] American Cancer Society. Breast cancer HER2 status [Internet; cited December 2023]. Available from: https://www.cancer.org/cancer/types/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html.[6] Scharl A, et al. The Right Treatment for the Right Patient - Personalised Treatment of Breast Cancer. Geburtshilfe Frauenheilkd. 2015;75(7):683–91.[7] Jorge Dino Cossetti R, et al. Comparison of breast cancer recurrence and outcome patterns between patients treated in 1986-1992 and 2004-2008. Journal of Clinical Oncology. 2014;32(15):521. [8] Dieci MV, et al. Biomarkers for HER2-positive metastatic breast cancer: Beyond hormone receptors. Cancer Treat Rev. 2020;88:102064.[9] Clinical trials.gov. A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) [Internet; cited December 2023]. Available from: https://clinicaltrials.gov/study/NCT01772472. [10] Cortazar P, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014;384(9938):164-72. [11] Verma S, et al. Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer. N Engl J Med. 2012;367(19):1783-91.[12] National Comprehensive Cancer Network (NCCN) Breast Cancer Guidelines – Version 4.2023 [Internet; cited December 2023]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.[13] Denduluri N, et al. Selection of optimal adjuvant chemotherapy and targeted therapy for early breast cancer: ASCO Guideline Update. J Clin Oncol. 2021;39(6):685-93. [14] Swain S, et al. Targeting HER2-positive breast cancer: advances and future directions. Nat Rev Drug Discov. 2023;22:101-26.[15] Schmid P, et al. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018;379:2108-21. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58Nathalie AltermattPhone: +41 79 771 05 25Simon GoldsboroughPhone: +44 797 32 72 915Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74Kirti PandeyPhone: +49 172 6367262 Dr. Rebekka SchnellPhone: +41 79 205 27 03Sileia UrechPhone: +41 79 935 81 48 Roche Investor Relations Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.comDr. Sabine BorngräberPhone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.comDr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.comDr. Gerard Tobin Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment 08122023_MR_KATHERINE_Kadcyla_en

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 <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., 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. Kadcyla is also approved for the treatment of people with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane. 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. About HER2-positive breast cancer Breast cancer is one of the most common cancers among women worldwide. Breast cancer is not one, but many diseases based on the biology of each tumor. In HER2-positive breast cancer, there is excess HER2 protein on the surface of tumor cells. Approximately 15-20% of breast cancers are HER2-positive based on the result of a diagnostic test. About Kadcyla Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells. It is designed to limit damage to healthy tissues, although it can still affect them. Kadcyla can cause serious side effects. It combines two anti-cancer agents using a stable linker: the HER2-targeting trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1. Kadcyla is the only ADC approved for the treatment of HER2-positive early and metastatic breast cancer. In the U.S., Genentech licenses technology for Kadcyla under an agreement with ImmunoGen, Inc. About Genentech in Breast Cancer Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have substantially improved outcomes for HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers. About Genentech 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 . Kadcyla U.S. Indication Statement Kadcyla is approved as an adjuvant (after surgery) treatment for HER2-positive early breast cancer when the patient has taken neoadjuvant (before surgery) treatment including a taxane and trastuzumab (Herceptin) and there is cancer remaining in the tissue removed during surgery. Patients are selected for therapy based on an FDA-approved test for Kadcyla. Kadcyla is approved to treat HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin) and a taxane. Prior treatment could have been for the initial treatment of breast cancer or for the treatment of cancer that had spread to other parts of the body. Patients are selected for therapy based on an FDA-approved test for Kadcyla. Important Safety Information Most important safety information about Kadcyla Liver problems Kadcyla may cause severe liver problems that can be life-threatening. Symptoms of liver problems may include vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), stomach pain, dark urine, or itching. Heart problems Kadcyla may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Symptoms may include swelling of the ankles or legs, shortness of breath, cough, rapid weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness, or irregular heartbeat. Pregnancy 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 Lung problems 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. Serious bleeding 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 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. Nerve damage 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 The most common side effects seen in people taking Kadcyla for early breast cancer are: Tiredness Nausea Liver problems Pain that affects the bones, muscles, ligaments, and tendons Bleeding Low platelet count Headache Weakness, numbness, and pain in the hands and feet Joint pain The most common side effects seen in people taking Kadcyla for metastatic breast cancer are: Tiredness Nausea Pain that affects the bones, muscles, ligaments, and tendons Bleeding Low platelet count Headache Liver problems Constipation Nosebleeds 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. Herceptin U.S. Indication Adjuvant Breast Cancer Herceptin is approved for the treatment of early stage breast cancer that is H uman E pidermal growth factor R eceptor 2 -positive ( HER2 -positive) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways: As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “ AC→TH. ” With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “ TCH. ” 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. Metastatic Breast Cancer Herceptin has two approved uses in metastatic breast cancer: Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of H uman E pidermal growth factor R eceptor 2 -positive ( HER2 -positive) metastatic breast cancer. Herceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease. Patients are selected for therapy based on an FDA-approved test for Herceptin. Important Safety Information Possible serious side effects with Herceptin 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: HEART PROBLEMS 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: Fever and chills Feeling sick to your stomach (nausea) Throwing up (vomiting) Pain (in some cases at tumor sites) Headache Dizziness Shortness of breath 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 Herceptin may result in the death of an unborn baby or birth defects. Contraception should be used while receiving Herceptin and for seven months after a patient's last dose of Herceptin. If a patient is or becomes pregnant while receiving Herceptin or within seven months after their last dose of Herceptin, the patient should immediately report Herceptin exposure to Genentech at (888) 835-2555. 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 Swelling of the lungs Scarring of the lungs 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. Side effects seen most often with Herceptin Some patients receiving Herceptin for breast cancer had the following side effects: Fever Feeling sick to your stomach (nausea) Throwing up (vomiting) Infusion reactions Diarrhea Infections Increased cough Headache Feeling tired Shortness of breath Rash Low white and red blood cell counts Muscle pain 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 .

MAFTEST® analyses of the NSABP-B34 and AZURE landmark clinical trials confirmed clinical utility of the MAFTEST® for selection of early-stage breast cancer patients that benefit from adjuvant clodronate treatment. Reduces the risk of death at 5 and 10 years by 26% and 23% respectively. Identifies almost twice as many patients able to benefit from the intervention than are selected using current clinical guidelines. Data published in Annals of Oncology, (33), SUPPLEMENT 3, S152, 2022. BARCELONA, Spain, July 14, 2022 /PRNewswire/ -- Inbiomotion SL, a company developing a unique single-gene-based biomarker for the personalized adjuvant treatment of early-stage (stage I-III) breast cancer patients, announces the results of comparing the clinical efficacy of implementing the proprietary MAFTEST® for selection of patients for adjuvant bisphosphonates therapy with current clinical guidance. The results were presented at the ESMO 2022 Breast Cancer Symposium. The data show that stratification of early breast cancer patients according to MAF status reduced the risk of death and relapse in MAF negative patients by 26% and 23% respectively, compared to a 12% and 15% reduction in the risk of death or relapse seen with stratification by menopausal status recommended by current ESMO and ASCO Clinical Guidelines. The data also indicate that adjuvant treatment with bisphosphonates should be avoided in MAF positive patients as the risk of death and relapse is increased 16% and 15% respectively in these patients. In addition, the study shows that the use of MAF status for selection of early breast cancer patients for treatment with bisphosphonates allows the treatment of young premenopausal patients currently excluded by existing clinical guidance. "The MAF biomarker allows a new paradigm for selection of patients for adjuvant bisphosphonate treatment of early breast cancer that not only identifies those patients that will benefit from treatment (MAF negatives) but also excludes patients that could be harmed (MAF positives). This new selection criteria not only reduces the risk of death and relapse for selected patients but also provides a new treatment option for young patients currently excluded from this treatment in current clinical practice," said Robert Coleman, Professor Emeritus, Department of Oncology and Metabolism, University of Sheffield, UK. Currently, clodronate and other bisphosphonates are not approved by the regulatory agencies for use in adjuvant treatment of the broad population of early-stage breast cancer patients. However, they are recommended in the ASCO/CCO and ESMO clinical guidelines for adjuvant treatment of breast cancer in postmenopausal patients. The study shows that identifying MAF-negative patients for selection for adjuvant treatment with bisphosphonates outperforms current selection by menopausal status and could give more patients, particularly younger patients, the opportunity to benefit from adjuvant bisphosphonates, while avoiding potential harm (or no benefit), than solely using menopausal status as a selection criterion. "Our results indicate that adjuvant clodronate treatment has a large clinical benefit if restricted to MAF-negative patients," said Prof. Alexander Paterson, principal investigator of the NSABP-B34 clinical trial and Emeritus Clinical Professor at the Department of Oncology, University of Calgary. "Our data provide an objective criterion for patient selection for bisphosphonate adjuvant treatment that outperforms current selection based on menopausal status." "This study confirms our previous findings and the clinical utility of MAFTEST® as a unique tool for precision medicine in early breast cancer. Every year approximately 355,000 women are diagnosed with early breast cancer in Europe with a 10% risk of death at 5 years. Using MAF Test these deaths could be reduced by 26%, which would translate to 9,230 lives saved," said Joël Jean-Mairet, Executive Chairman of the Board of Inbiomotion. "We have discovered and developed a new biomarker, MAF gene amplification, that if used as selection criteria for adjuvant treatment with bisphosphonates improves the clinical outcome of breast cancer patients compared with current clinical practice, " said Prof. Roger Gomis, ICREA Research Professor at IRB Barcelona. "MAF Test is a biomarker that is easy to implement in any clinical pathology lab and should be considered for routine characterization of breast cancer tumors." Recently the MAFTEST® obtained the CE-mark as an in vitro diagnostic medical device for prognostic purposes. Since clodronate and other bisphosphonates are not approved by the regulatory agencies for use in adjuvant treatment of early-stage breast cancer patients, Inbiomotion's MAFTEST® is not authorized to be used as a companion diagnostic as described in the above-mentioned study. Reference articles: Impact of MAF selection of patients for adjuvant bisphosphonate therapy and comparison with current clinical guidance Robert Coleman, Roger R Gomis, Alexander H G Paterson. Full text article : (22)00461-6/fulltext MAF amplification and adjuvant clodronate outcomes in early-stage breast cancer in NSABP B-34 and potential impact on clinical practice Alexander H G Paterson et al. Full text article: Effect of MAF amplification on treatment outcomes with adjuvant zoledronic acid in early breast cancer: a secondary analysis of international, open-label, randomized, controlled, phase 3 AZURE (BIG 01/04) trial Robert Coleman et al. Full text article: (17)30603-4/fulltext Benefits and risks of adjuvant treatment with zoledronic acid in stage II/III breast cancer. 10 years follow-up of the AZURE randomized clinical trial (BIG 01/04) Robert Coleman et al. Full text article: About Inbiomotion: Inbiomotion SL, a company founded by Prof. Roger Gomis, is developing a unique single gene-based biomarker for the personalized adjuvant treatment of early-stage breast cancer patients. The biomarker has been technically and analytically validated. The results of the first trial using well annotated archived specimens of the AZURE registrational clinical trial, now confirmed in the NSABP-B34 trial, indicate its potential use as a companion diagnostic. The company holds over 200 patents and patent applications covering its proprietary FISH MAFTEST® and the use of bisphosphonates in the adjuvant treatment of early-stage breast cancer patients. About MAF: MAF (mesenchymal aponeurotic fibrosarcoma gene, an AP-1 family transcription factor) is expressed in primary cancer tumors. This is associated with increased metastasis, especially bone metastasis. MAF transcriptionally controls genes such PTHrP, which regulate metastasis-related cellular processes, including survival, initiation, metabolic rewiring, and particularly, adhesion to bone marrow–derived cells and osteoclast differentiation. These observations point to MAF having a key hierarchical role in metastasis. SOURCE Inbiomotion