Roche's ADC drug Hercules is approved

Roche pharmaceutical China announced that the State Drug Administration officially approved the innovative targeted drug hesaile (English trade name: kadcyla, general name: enmettrazumab), which is applicable to the adjuvant treatment of HER2 positive early breast cancer patients who still have invasive lesions after receiving the new adjuvant treatment based on taxanes combined with trastuzumab As the world's first approved antibody drug conjugates for single drug treatment of solid tumors, it is also the first HER2 targeted ADC product in China The approval of HER2 positive breast cancer patients enriches the choice of intensive adjuvant therapy for residual lesions after new adjuvant therapy, which makes the patients with high risk of recurrence closer to cure The approval of herselle is based on the Katherine study, which is the first global, multi center, phase III key registered clinical study on how to optimize adjuvant treatment for HER2 positive breast cancer patients who still have residual lesions after new adjuvant treatment Although the marketing of Herceptin (trastuzumab) and patozumab has changed the clinical outcome of HER2 positive breast cancer patients, about 25% of HER2 positive early breast cancer patients will relapse and metastasis after 10 years However, 40-60% of the patients who did not reach PCR after the new adjuvant therapy were treated with Herceptin (trastuzumab) + pajite (patozumab), and the recurrence risk of those who did not reach PCR within 5 years was higher than that of the patients who did not reach PCR after the new adjuvant therapy, a few of them were even close to 80% Hercules (enmettrazumab) also brings hope to these patients According to Katherine study, within 3 years after adjuvant treatment, the noninvasive cancer survival rate (IDFs) was 88.3% in the group of entetrazumab and 77% in the group of trastuzumab The absolute difference between the two groups was 11.3% (HR: 0.5, 95% CI: 0.39-0.64), After using t-dm1, whether Er is positive or negative, whether it can be operated or not, or even in patients with small tumor residual, less than 1cm or lymph node negative, the risk ratio HR is 0.6 It means that for the patients with HER2 positive breast cancer who still have residual lesions after the new adjuvant therapy, after the treatment with enmettrazumab, the risk of disease recurrence and death can be further reduced by 50% The amazing performance of entetrazumab in the treatment has nothing to do with its innovative mechanism Hesaille (enmetrastuzumab) is a stable antibody coupling drug, which connects the classical anti HER2 targeting drug Heseltine (trastuzumab) and the chemotherapy drug meddensin, which inhibits microtubule aggregation, through the thioether linker It has the characteristics of killing tumor cells and is also known as a "biological missile" Hesaile (enmetrastuzumab) can deliver strong chemotherapeutic drugs directly to HER2 positive cancer cells, give full play to the role of targeted drugs, and can carry out chemotherapy killing effect, and at the same time limit healthy tissues from its harm At present, in the treatment of HER2 positive early breast cancer, the new adjuvant therapy before operation and the adjuvant therapy after operation are all part of the comprehensive treatment of early breast cancer The purpose of early breast cancer treatment is to provide patients with the best chance to cure The goal of new adjuvant therapy for breast cancer is not only to reduce the inoperable breast cancer to the operable breast cancer, but also to reduce the non breast cancer to the breast cancer, and to obtain the drug sensitivity information in vivo, so as to guide the follow-up treatment to improve the long-term survival of patients The Katherine study showed that for patients with residual lesions after neoadjuvant surgery, the use of hesaille (enmetrastuzumab) during the adjuvant treatment phase can reduce the risk of cancer recurrence or death by 50% Therefore, according to whether patients can achieve PCR after new adjuvant therapy, it will become the treatment decision point of individualized adjuvant therapy in the future According to neosphere research, compared with the treatment of pure Herceptin (trastuzumab), the new adjuvant HER2 treatment of pajiete (patzumab) combined with Herceptin (trastuzumab) can improve the rate of pathological complete remission (PCR) in high-risk patients, but 60% of patients can not achieve pathological complete remission (PCR) after the new adjuvant treatment In the field of HER2 positive breast cancer treatment, Roche's developed drugs have established an anti HER2 treatment system from the initial new adjuvant treatment, postoperative adjuvant treatment, and the whole process of advanced first-line treatment, and more and more Chinese patients benefit from the treatment In addition to HER2 positive breast cancer, Roche has also made progress in the treatment of three negative breast cancer, one of the most dangerous breast cancer classifications Tecentriq, the world's first tumor immunotherapy drug for triple negative breast cancer, has been approved by FDA Tecentriq can bind to PD-L1 ligand protein expressed on tumor cells and tumor infiltrating immune cells, and block its interaction with PD-1 and B7.1 receptors Tecentriq can activate T cells effectively by blocking PD-L1 pathway.