Keytruda was approved as the first PD-1 therapy for NMIBC!

Organize Holly On January 8, local time, FDA of the United States announced the approval of keysruda (pembrolizumab), a PD-1 inhibitor of methadone, as a single drug therapy for the treatment of specific high-risk non muscle invasive bladder cancer (NMIBC) patients, specifically: not eligible for bladder resection or has chosen not to undergo bladder resection of BCG vaccine non response, high-risk, with in situ cancer (CIS), with or without papillary lesions of nm IBC patients Prior to this, keytruda's supplementary biological product licensing application (SBLA) for the treatment of high-risk NMIBC patients has obtained the priority review qualification granted by the FDA In mid December 2019, the FDA oncology drug advisory committee (ODAC) supported the approval with a vote of 9:4 This approval also made keytruda the first PD - (L) 1 treatment available for NMIBC The approval is based on the results of a multicenter single arm phase II clinical keynote-057 study A total of 148 high-risk NMIBC patients were enrolled in the study, 96 of whom had CIS without response to BCG with or without papillary lesions Patients received 200 mg of keytruda at a fixed dose every 3 weeks until relapse, progression, unacceptable toxicity, or 24 months in patients without progression The results showed that the complete remission rate was 41% (95% CI: 31, 51), the median remission time was 16.2 months, and 46% of the patients with complete remission time more than 12 months One year later, 46% of the initial responders maintained remission, accounting for 19% of all patients in the efficacy analysis, which was lower than the 30% standard recommended by the international bladder cancer group Cystocarcinoma starts with uncontrolled growth of cells in the bladder As more cancer cells emerge, they can form tumors and spread to other parts of the body Bladder cancer is described by the extent to which it invades the bladder wall NMIBC occurs when cancer cells do not grow into the main muscle layer of the bladder It is estimated that more than 80000 cases of bladder cancer will be confirmed in the United States in 2019, and about 75% of bladder cancer patients will be diagnosed with NMIBC For the high-risk NMIBC patients who have no response to BCG vaccine and have persistent or recurrent diseases, radical cystectomy is recommended in the treatment guidelines, which is a kind of operation to remove the whole bladder, usually requires removal of other surrounding organs and tissues The choice of treatment for high-risk NMIBC has always been limited, many patients can only rely on surgery after relapse In addition, about 40% of patients with high-risk NMIBC developed muscle infiltrative disease In the keynote-057 study, keytruda single drug therapy achieved a complete remission rate of over 40%, which is very encouraging for patients with refractory high-risk NMIBC who are not qualified to accept or refuse to accept cystectomy Keytruda, a blockbuster drug of methadone, has been approved to treat more than 20 indications At present, more than 1000 clinical trials study keytruda in various cancer and treatment environments, aiming to understand the role of keytruda in cancer treatment and predict the factors that patients can benefit from keytruda treatment In June, MSD said at the investors' day meeting that keytruda's approved treatment indications are expected to more than double in the next five years Reference source: FDA approvals pembrolizumab for BCG unresponsive, high risk non muscle invasive blinder cancer