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The results of phase DESTINY-CRC01II clinical trials conducted byAstraZeneca and Phase 1301,, show that Enhertu (trastuzumab deruxtecan), or DS-8201) is used in PATIENTs with HER2-positive, non-reprectable and/or metastatic colorectal cancer who have received two or more standard treatments in the past, with clinical significance.colorectal cancer is the third most common cancer in the world and the second most common fatal cancerThere are currently no specific treatments approved for HER2-positive colorectal cancer patients, and about 2% to 5% of patients with such colorectal cancer suffer from the diseaseThe main endpoint of thetrial was the confirmed objective mitigation rate (ORR) assessed by the Independent Centre Review Committee45.3% of PATIENTS WITH ADVANCED COLORECTAL CANCER WITH A SINGLE TREATMENT OF DS-8201 (6.4 MG/KG) ACHIEVED TUMOR REMISSION IN PATIENTS WITH A SINGLE TREATMENT OF DS-8201 (6.4 MG/KG)The disease control rate (DCR) was 83.0% and the median progression less (PFS) in patients was 6.9 monthsAt the data cut-off, both the mitigation duration (DoR) and the median total lifetime (OS) have not been reachedDr Salvatore Siena, professor of oncology and hematomy at the University of Milan, Italy, and lead researcher of the DESTINY-CRC01 trial, said: "It is important to explore new treatments such as HER2 targeted therapy for patients with colorectal cancerBecause for advanced patients, there are few options for treatment once the disease progressesIn particular, the results of the DESTINY-CRC01 trial are particularly noteworthy and deserve further study, especially in the light of the fact that many HER2-positive patients with advanced colorectal cancer have previously received multiple-line treatment"These clinically significant and long-lasting reliefs in the treatment of PATIENTs with HER2-positive advanced colorectal cancer make us firmly believe that HER2 is an important target for treating the disease," said Jos? Baselga, Executive Vice President, Oncology Development,AstraZenecaCurrently, DS-8201 has demonstrated remarkable clinical efficacy in four different cancers, further demonstrating the potential of this extraordinary drug to help cancer patients improve treatment in different HER2 targeted tumors "The prognosis of metastatic colorectal cancer is extremely poor, with limited follow-up options for patients with first-line progression, and no specific HER2-positive targeted therapy approved at this time," said Antoine Yver, executive vice president of and global head of oncology development We are encouraged by the mitigation rates shown by the treatment of DS-8201 for patients with advanced colorectal cancer, and we will continue to explore the potential of DS-8201 to address this unmet medical need "
CI,;CR,;PR,;SD,;NE,
i.DS-8201 6.4 /
ii.HER2(IHC3+ IHC2+/ISH+)
iii.
iv.(ORR)=([CR] + [PR])
v.(DCR) =([CR] + [PR] +[SD])
HER2(IHC2+/ISH-IHC1+),。 pre-defined exploratory analysis assessed the objective remission rate (ORR) in subgroups of patients, including patients treated with antiHER2 regimens (n-16) The objective remission rate observed in these patients was 43.8% (ORR) (95% CI, 19.8-70.1) Patients received a median fourth-line treatment (2-11 lines), and all patients had previously received chemotherapy treatment from Iliticon and Osaliplatinum, with a median treatment time of 4.8 months (1-11 months) As of August 9, 2019, 38.5% (30 out of 78) patients were still being treated in each queue The overall safety and tolerance demonstrated by DS-8201 in the DESTINY-CRC01 trial was consistent with the previously reported DS-8201 test The most common treatment-related adverse events of level 3 or above were a decrease in neutropen cell count (25.6%) and anemia (14.1%) The IMIC review committee identified five cases (6.4 per cent) of interstitial pulmonary disease (ILD) and pneumonia Two of the cases were level 2, one was level 3, and two deaths (level 5) were attributed to interstitial pulmonary disease (ILD)