A quick look at the news about foreign "medicine" this month

A quick overview of key foreign drug news this month: Roche T drug was approved to treat early lung cancer; FDA approved Merck K drug combined with chemotherapy for first-line treatment of cervical cancer; AstraZeneca Imfinzi combined with tremelimumab to treat liver cancer phase 3 clinical end; Eli Lilly Verzenio was awarded FDA approved the treatment of early breast cancer
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Roche: T drug approved to treat early-stage lung cancer On October 15, Roche announced that FDA has approved its Tecentriq ("T drug") as an adjuvant therapy to treat patients with stage II-IIIA non-small cell lung cancer after surgery and platinum-containing chemotherapy
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Drug T is a PD-L1 inhibitor that blocks the binding of PD-L1 to PD-1 and CD80 proteins to relieve tumor cells from inhibiting the immune response
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The approval is based on the results of an interim analysis of a phase 3 clinical trial
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The test results showed that in patients with stage II-IIIA NSCLC (PD-L1≥1%), after receiving surgical resection and platinum-containing chemotherapy, treatment with Tecentriq reduced the risk of disease recurrence or death by 34% (HR=0.
66, 95 % CI: 0.
50-0.
88)
.
Roche said the product is the first immunotherapy approved for adjuvant treatment of non-small cell lung cancer
.
Merck: FDA approves drug K combined with chemotherapy for the first-line treatment of cervical cancer On October 13, Merck announced that the FDA approved drug K in combination with platinum-containing chemotherapy, with or without bevacizumab, for first-line treatment of tumors expressing PD-L1 (CPS).
Patients with persistent, recurrent or metastatic cervical cancer with score ≥ 1)
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The approval is based on the positive results of a pivotal Phase 3 clinical trial
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The results showed that compared with chemotherapy, pembrolizumab + chemotherapy reduced the risk of death by 36%
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Merck said this is the first anti-PD-1 therapy approved for first-line treatment of patients with cervical cancer
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In addition, according to recent news, Merck has launched a phase 3 clinical trial in China to "evaluate the protective efficacy, immunogenicity and safety of the nine-valent human papillomavirus vaccine in Chinese men.
"
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This is a three-phase randomized, double-blind, placebo-controlled clinical study aimed at males to evaluate the protective efficacy, immunogenicity and safety of Jiadaxiu 9 in Chinese men between 20 and 45 years old
.
AstraZeneca: Imfinzi combined with tremelimumab in the treatment of liver cancer reached the end point on October 15, AstraZeneca announced that the combination of Imfinzi and tremelimumab, the first-line treatment of patients with unresectable hepatocellular carcinoma phase 3 clinical trial reached the overall survival period The main end point
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Imfinzi is an anti-PD-L1 monomer, by blocking the binding of PD-L1 to PD-1 and CD80 proteins, it relieves tumor cells from inhibiting the immune response
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Tremelimumab is a CTLA-4 monoclonal antibody, which promotes T cell activation by blocking the activity of CTLA-4 and stimulates the immune system's immune response to cancer
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Combination therapy aims to stimulate T cell activation while reducing the toxic and side effects of CTLA-4 antibodies
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Phase 3 clinical trial data showed that in addition to significantly prolonging the overall survival of patients, the combination therapy also showed good safety and did not increase severe liver toxicity
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Eli Lilly: Verzenio receives FDA approval for the treatment of early-stage breast cancer.
On October 13, Eli Lilly announced that the FDA has approved Verzenio to expand its indications, combined with endocrine therapy (tamoxifen or aromatase inhibitor), and adjuvant therapy for hormone receptor positive , Human epidermal growth factor receptor 2 negative, lymph node positive, early breast cancer patients with high risk of recurrence
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Verzenio is a CDK4/6 inhibitor that can block the progression of the cell cycle, leading to cell senescence and apoptosis
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The approval is based on a Phase 3 clinical result
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The results show that Verzenio combined with endocrine therapy reduces the risk of recurrence in patients by approximately 36% compared with single endocrine therapy
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