On January 8, the NMPA official website showed,MSDThePembrolizumab(K Drug)AndAstellasVenantuximab Injection Combination Therapy Approved for Marketing in China, Combined Use forPreviously untreated locally advanced or metastatic urothelial carcinoma（la/mUC）First-line Treatment for Adult Patients(Application No.: JXSS2400030/31)/33）。
Screenshot source:NMPA Official Website
Pembrolizumab has previously been approved for more than ten indications in China, covering melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, colorectal cancer,Hepatocellular carcinoma, triple-negative breast cancer, MSI-H/dMMR solid tumors, gastric cancer, biliary tract cancer, and other cancer types.Vientamab（Enfortumab Vedotin，Padcev）Developed by Astellas and Seagen (now acquired by Pfizer), it consists of Enfortumab, a human IgG1 monoclonal antibody targeting Nectin-4, and the cytotoxic agent monomethyl auristatin E.（MMAE）Coupled together.Currently, the drug has been approved by the FDA for three indications, covering all lines of therapy from third-line to first-line treatment for urothelial cancer.August 2024,Vientamab Approved for the First Time in China, for the treatment of patients with locally advanced or metastatic UC who have previously received PD-1/PD-L1 inhibitors and platinum-based chemotherapy.(Third-line Therapy)。
Screenshot source: Insight databaseThis time, Vedolizumab combinedPembrolizumabThe approval of the first-line treatment for UC indication was based on the clinical trial EV-302.（KEYNOTE-A39）The result.EV-302 is an open-label, randomized, controlled Phase III trial designed to evaluate the efficacy and safety of enfortumab vedotin in combination with pembrolizumab versus chemotherapy for previously untreated patients with locally advanced or metastatic urothelial carcinoma (la/mUC). The trial enrolled 886 previously untreated patients with locally advanced or metastatic urothelial carcinoma who were able to tolerate platinum-based chemotherapy, regardless of their PD-L1 expression.The results presented at the 2024 ESMO conference showed that, as of August 8, 2023, the median follow-up time was 17.2 months.Compared with first-line standard chemotherapy, the combination of Vinblastine and Pembrolizumab significantly extended mPFS in la/mUC patients by more than 6 months, reducing the risk of disease progression and death by 55%.(12.5 months vs 6.3 months, HR=0.45, P<0.00001); meanwhile, patients treated with Venetoclax + Pembrolizumab combination therapymOS significantly extended by 15.4 months，53% Reduction in Risk of Death(31.5 months vs 16.1 months, HR=0.47, P<0.00001)Moreover, the PFS and OS of each predefined subgroup were consistent with the overall population.Moreover, compared with first-line standard chemotherapy, the combination therapy of Vinblastine monoclonal antibody + Pembrolizumab has a higher ORR value.（67.7% vs 44.4%，P<0.00001）; among which, the combination therapy group achievedComplete Remission（CR）The percentage of patients is 29.1%.(12.5% in the chemotherapy group), achieving partial remission（PR）The percentage of patients was 38.7% (32.0% in the chemotherapy group).In terms of safety, the incidence of treatment-related adverse events (TRAE) in the venetoclax + pembrolizumab group was generally manageable, with no new safety signals identified.Vedimtoximab + Pembrolizumab to Replace Current Standard First-Line Chemotherapy for Locally Advanced or Metastatic UCBecoming China's First Combination Therapy to Replace ChemotherapyMoreover, the 2024 CSCO Urothelial Carcinoma Diagnosis and Treatment Guidelines have recommended vinblastine + pembrolizumab as the first-line preferred treatment option.As the world's first and only Nectin-4 targeted ADC approved for marketing,After its launch, the sales of Vedotin gradually increased year by year. In the first half of 2024, the sales reached 1.171 billion US dollars (the total sales of Pfizer and Astellas), ranking third in ADC sales.
Screenshot source: Insight databaseNectin-4 It is a type I transmembrane polypeptide,Considered as a potential biomarker and promising target for cancer treatment,Specifically expressed in embryos, placenta, and tumor cells, and its abnormal expression is associated with tumor progression and poor prognosis.According to the Insight database, there are multiple Nectin-4 targeted ADCs currently under research in China.- MabwellThe9MW2821In Phase III clinical trials;
- Hengrui Medicine's SHR-A2102 has also entered Phase III, and CSPC's SYS6002 has entered Phase II clinical trials;
- SKB410 from Kelun Botai, ADRX-0706 from Defeng Pharmaceutical/Adcentrx, and BAT8007 from Bio-Thera have entered Phase I clinical trials.
Overview of Nectin-4 Targeted ADC Development Progress in ChinaScreenshot source: Insight database
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