Another indication of pajite (R), an innovative breast cancer targeting drug owned by Roche, was approved in China

December 10, 2019 / AP / -- Roche pharmaceutical China announced on December 10 that China's National Drug Administration (nmpa) officially approved the first-line standard treatment plan of pajite ® (patozumab) combined with Herceptin ® (trastuzumab) and docetaxel for HER2 positive metastatic breast cancer patients who have not received anti HER2 treatment or chemotherapy The approval of this program has realized the gradual internationalization of the treatment program for HER2 positive advanced breast cancer patients in China, will bring more long-term survival benefits for HER2 positive advanced breast cancer patients, help to realize the slow disease management of breast cancer diagnosis and treatment, and make it possible for advanced breast cancer to get rid of "terminal disease" The combination of paclobutzumab, trastuzumab and docetaxel is a standard first-line treatment for HER2 positive advanced breast cancer in the world [1] Now, the approval of Paget ® breast cancer advanced first-line indications in China is not only of great significance to domestic patients, but also will further promote the process of standardized diagnosis and treatment of advanced breast cancer in China The survival rate of patients with advanced breast cancer is only 20% and double target will rewrite the outcome of advanced treatment breast cancer is the most common malignant tumor in Chinese women, ranking the first place in the incidence of female malignant tumors HER2 positive breast cancer accounts for about 20% - 30% [2] Because of its high malignancy, rapid progress, lymph node metastasis, short remission period of chemotherapy, relative resistance to endocrine therapy and other characteristics, it brings many difficulties to clinical treatment, and the overall quality of life of patients is low In China, about 3% - 10% of new cases of breast cancer have distant metastasis at the time of diagnosis Among the early patients, 30-40% will develop into advanced breast cancer, with a 5-year survival rate of only 20%, and a median overall survival time of only 2-3 years [2] The approval of the first-line treatment indication for advanced breast cancer of Paget ® will bring longer survival benefits for patients with HER2 positive advanced breast cancer The approval of the first-line treatment indication of Paget ® HER2 positive advanced breast cancer is mainly based on the results of Cleopatra clinical study and puffin study from Chinese population which lasted for 8 years Cleopatra study results show that patazozumab + trastuzumab combined with docetaxel can prolong the progression free survival (PFS) of patients with HER2 positive advanced breast cancer by 51%, reaching 18.7 months, the total survival (OS) of patients by 40%, and the survival period can be extended to nearly 5 years [3] With the extension of the follow-up time, 37% of the patients in the treatment group achieved eight-year survival at a median follow-up of 8 years (the longest follow-up was 10 years), which was significantly higher than that in the trastuzumab group (23%) The puffin study is a bridging study of Cleopatra 243 cases of HER2 positive advanced breast cancer are all Chinese patients They come from 15 clinical centers in China Their results are similar to those of previous Cleopatra studies The trend of PFS benefit in puffin study is consistent with the global data [4] From Cleopatra to puffin, we can see that the combination of patuzumab and trastuzumab plus docetaxel can further prolong the progression free survival (PFS) than trastuzumab Professor Xu binghe, National Cancer Center and Cancer Hospital of Chinese Academy of Medical Sciences, who led the study of puffin, pointed out: "the study of puffin has proved that the efficacy of double targets in Chinese HER2 positive advanced breast cancer patients is highly consistent with the international Cleopatra study It is confirmed that the dual target regimen of patozumab combined with trastuzumab has the same safety and survival benefits in Chinese patients, which provides strong evidence-based medical evidence for Chinese patients to use the dual target regimen of patozumab combined with trastuzumab more safely We believe that with a longer follow-up time, we will also see that the total survival time (OS) in the puffin study will display the amazing data of Chinese people, further promoting the change of diagnosis and treatment pattern of HER2 positive advanced breast cancer in China " How can the double target regimen of patozumab and trastuzumab effectively promote the chronic management of advanced breast cancer? Professor Jiang zefei, vice president of the Chinese society of Clinical Oncology (CSCO), explained: "Cleopatra study published an 8-year follow-up this year, and the overall 8-year survival rate of patients is close to 40% In the field of breast cancer treatment, it is difficult for us to observe the research for such a long time, because it is terminal patients after all From the Cleopatra results, it is not difficult to see that the vast majority of patients can achieve long-term survival benefits after receiving the appropriate double target treatment " In addition, pajite ® (patozumab) + Herceptin ® (trastuzumab) + chemotherapy can also bring full benefits to patients with HER2 positive advanced breast cancer in the first-line treatment Its curative effect is not affected by the treatment of trastuzumab, age and hormone receptor status It can also maintain significant benefits in the HER2 positive advanced patients with brain metastasis, visceral metastasis and bone metastasis [5], bringing dawn to all the advanced patients, making it possible for the late breast cancer to get rid of "terminal disease" For patients with advanced breast cancer, experts call, on the one hand, we still need to strengthen early diagnosis, early detection, in order to reduce the incidence of the first diagnosis is advanced breast cancer On the other hand, for some patients who will develop into late stage due to various reasons, we should pay attention to intervene as early as possible in accordance with the guidelines, so as to prolong the life span of patients and improve their quality of life "By 2022 and 2030, the overall 5-year survival rate of cancer will be no less than 43.3% and 46.6%, respectively," was mentioned in the outline of "healthy China 2030" issued by the CPC Central Committee and the State Council on July 15, 2019 At present, the 5-year survival rate of early breast cancer patients in China is up to 83.2% [6], which has achieved the transformation of "chronic disease"; however, if we want to improve the overall survival rate of breast cancer, it is particularly important to supplement the short board that the survival rate of current late breast cancer patients is only 20% Therefore, the approval of double target, first-line and advanced treatment indications also responds to this demand, which will help improve the survival rate of patients with advanced breast cancer in China and contribute to the construction of a healthy China The indications are approved one after another Roche provides the whole process management for breast cancer patients Zhou Hong, President of Roche pharmaceutical China, said: "although pajite ® (patozumab) entered China later than the European and American markets, all three indications were approved in China in one year, in line with the European and American markets This world-class approval speed shows the determination of the Chinese government to accelerate the introduction of innovative drugs through reform and continuously improve the health level of the Chinese people Roche will continue to adhere to the concept of "patient needs first", on the basis of innovative research and development, bring more innovative products to the market, and benefit more breast cancer patients in China " In December 2018, the first indication of Pagett ® was approved in China for adjuvant treatment of HER2 positive early breast cancer patients with high risk of recurrence in combination with trastuzumab and chemotherapy, which significantly reduced the recurrence risk of HER2 positive early breast cancer patients with high risk of recurrence, indicating that China's anti HER2 treatment officially entered a double target era In August 2019, China's State Drug Administration approved the combination of patozumab with trastuzumab and chemotherapy for the new adjuvant treatment of HER2 positive patients with locally advanced, inflammatory or early breast cancer (diameter > 2cm or lymph node positive) As part of the overall treatment plan for early breast cancer, it provides a new preoperative treatment option for HER2 patients with early breast cancer Today, the approval of the first-line treatment indication of Paget ® HER2 positive advanced breast cancer is the third indication approved in China The combination chemotherapy of patorzumab and trastuzumab has constructed the whole process of HER2 inhibition management from the initial new adjuvant stage to the postoperative adjuvant medium and even late treatment, which has a positive significance for the standardized diagnosis and treatment of breast cancer in China Recently, the medical insurance negotiation has been settled, and Herceptin in the double target treatment scheme has been successfully renewed through the national medical insurance negotiation, and new indications for adjuvant treatment have been added; while pajite ® is used for new adjuvant treatment of locally advanced, inflammatory or early breast cancer patients with HER2 positive and for adjuvant treatment of patients with HER2 positive early breast cancer with high risk of recurrence List of drugs for basic medical insurance, work injury insurance and maternity insurance It is believed that under the protection of the national health insurance policy, the access of patients to medication will be greatly improved, and more and more breast cancer patients can receive standard double target treatment and benefit from it [1] Swain SM, baselga J, Kim sb, et al.pertuzumab, trastuzumba, and docetaxel in HER2-positive metallic breast cancer [J] N Engl J Med, 2015, 372 (8): 724-734 [2] consensus on clinical diagnosis and treatment of advanced breast cancer in China (2018 Edition), Chinese Journal of cancer, Vol 40, No 9, 2018 [3] Swain SM, et al Asco.2019 Abstract 1020 [4] binghe Xu, Et al 2019 ASCO Abstract 1026 [5] Russia m a, et al In vivo 2018 Jul Aug; 32 (4): 839-842 [6] binghe Xu, et al 2019 ASCO Abstract 1026 source: Roche pharmaceutical 37