Padcev and keytruda are successful in the treatment of stage Ib / II urothelial carcinoma!
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Last Update: 2020-02-17
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Source: Internet
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Author: User
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Fan Dongdong Last fall, Wall Street was impressed by the excellent performance of the antibody drug conjugate padcev (enfortumab vedotin ejfv) jointly developed by Estella and Seattle genetics Recently, the two companies announced the latest results of padcev combined with keytruda in the stage Ib / II clinical trial of locally advanced or metastatic urothelial carcinoma ev-103 The results showed that after a median follow-up of 11.5 months in 45 patients, padcev + keytruda combination therapy reached the therapeutic safety index, with an objective response rate of 73.3%, a complete response rate of 15.6%, and a partial response rate of 57.8% In addition, 83.9% of the patients in the combined therapy group had a remission duration of more than half a year, and 53.7% had a remission duration of more than one year Overall, the median progression free survival was 12.3 months and the one-year overall survival rate was 81.6% The two companies also said that after receiving padcev and keytruda treatment, 71% of the patients' tumors contracted, and 13% of the patients were completely eliminated during the treatment Analysts say such a positive test data is enough to pass the FDA's regulatory review In addition, a market observer raised padcev's top sales forecast directly to $5.8 billion after the release of test data Padcev is an antibody conjugated drug targeting for the expression of nectin-4, a cell adhesion molecule highly expressed in urothelial carcinoma The drug has been awarded the FDA's breakthrough therapy recognition and priority evaluation qualification In December 2019, padcev obtained FDA's accelerated approval, three months ahead of PDUFA's target date, for the treatment of local advanced or metastatic urothelial cancer patients who had previously received a PD-1 / L1 inhibitor treatment and had received a platinum containing chemotherapy scheme in neoadjuvant / adjuvant treatment or in the treatment of local advanced or metastatic diseases.
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