Immunotherapy for NMIBC! The new indications of kestruda have been recommended and approved by FDA Expert Committee!

December 19, 2019 / BIOON / -- cancer immunotherapy giant Merck & Co recently announced that the US Food and Drug Administration (FDA) cancer The Drug Advisory Committee (ODAC) voted 9-4 to approve keytruda (Chinese trade name: coreida, common name: pembrolizumab, pabolizumab) as an anti PD-1 therapy for some patients with high-risk muscle infiltrating prostate cancer (NMIBC) The discussion of ODAC is based on a supplementary biological product licensing application (SBLA), which is currently being accepted FDA's priority review sought to approve keytruda's new indication as a single drug therapy for patients with non compliant or non responsive BCG, high-risk NMIBC with in situ cancer (CIS), with or without papillary tumor who have chosen not to undergo cystectomy (cystectomy) Mr mershadong had previously expected the SBLA's prescription drug user fee Act (PDUFA) target date to be January 2020, based on a priority review Dr Roy Baynes, chief medical officer, senior vice president and director of global clinical development of Merck Research Laboratory, said: "the voting results of today's ODAC meeting support the potential of keytruda in the treatment of certain high-risk, non muscle invasive prostate cancer patients Currently, there are limited FDA approved non-surgical treatment options for such patients We are encouraged by today's fruitful discussions and look forward to working closely with the FDA in the review process " This SBLA was based on the results of keynote-057 (nct02625961) in phase II clinical trial This is a multicenter, open label, single arm trial in which cohort a enrolled 102 patients with NMIBC who were unresponsive, high-risk, with CIS, with or without papillary tumor, who did not meet or chose not to undergo cystectomy In this study, the high-risk NMIBC with no response of BCG was defined as: Although receiving sufficient BCG treatment, there were still persistent diseases; after receiving enough BCG treatment and experiencing initial tumor free state, the disease relapsed; after receiving a single induction course of BCG, the disease progressed to T1 disease In the study, patients received a fixed dose of keytruda 200mg intravenously once every three weeks until unacceptable toxic, persistent or recurrent high-risk NMIBC or disease progression During the treatment, the tumor was evaluated every 12 weeks, and patients without disease progression could be treated for up to 24 months The main outcome measures were complete remission (Cr, defined as negative results of cystoscopy, urine cytology, and CT urography) and duration of remission (DOR) Data from this study were first published at the annual meeting of the European Society of Oncology (ESMO) in October 2018: at the mid-term analysis, keytruda was treated for 3 months with a complete remission (CR) rate of 38.8% (95% CI: 29.4-48.9) The non CR rate at 3 months of treatment was 55.3% (95% CI: 45.2-65.1), and these patients had persistent disease (CIS + / - papillary tumor), NMIBC stage progression (baseline CIS + / - high level TA progression to T1 disease), or extravesical disease At the time of analysis, 72.5% of Cr patients had sustained response (n = 29 / 40), and 25% had relapse after Cr (n = 10 / 40) A patient who did not have a relapse stopped the study and began alternative treatment No patients in cohort a developed muscle infiltrating or metastatic urothelial carcinoma (UC) Of the patients who reached CR after 3 months of treatment, 80% had CR for 6 months or longer The median duration of remission was not reached (0 + to 14.1 +) The median follow-up time was 14.0 months (4.0-26.3 months) The safety of keytruda in this study was consistent with previous trials in keytruda monotherapy patients 63.1% of the patients had treatment-related adverse events (RAE) The most common trae was pruritus (10.7%), asthenia (9.7%), diarrhea (8.7%), hypothyroidism (5.8%) and macular papule (5.8%) 13 patients (12.6%) had a 3-5-level Rae, and according to the investigator's assessment, one death was related to treatment Bladder cancer is the sixth most common cancer in the United States, about 80% of which is NMIBC, that is, cancer cells are located in the bladder or have grown into the bladder cavity, but have not spread to muscle or other tissues NMIBC mainly affects men and is related to carcinogen exposure The recurrence rate after initial surgical resection is very high, more than 60% of patients will receive BCG immunotherapy Although BCG is effective in many patients, tolerance problems have been observed and many patients experience relapses For high-risk NMIBC patients with unresponsive, persistent or recurrent diseases treated by BCG, radical cystectomy, or radical cystectomy, is recommended in the guideline Keytruda belongs to PD - (L) 1 tumor immunotherapy, which helps detect and fight against tumor cells by improving the ability of human immune system Keytruda activates T lymphocytes that may affect tumor cells and healthy cells by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2 So far, a number of PD - (L) 1 tumor immunotherapies have been approved worldwide, among which keytruda is the leader in this field and has approved more than 20 treatment indications At the end of last month, keytruda was approved by the National Drug Administration of China (nmpa) for the first-line treatment of metastatic squamous cell non-small cell lung cancer (NSCLC) with carboplatin and paclitaxel It is worth mentioning that this approval is also keytruda's third first-line approval in NSCLC treatment in less than a year Now, the drug is the first anti PD-1 therapy approved by China for the first-line treatment of squamous and non squamous NSCLC combined with chemotherapy, and single drug treatment of NSCLC (tumor proportion score [TPS] ≥ 1%) Original source: FDA oncologic Drugs Advisory Committee (ODAC) recommendations keytruda ® (pembrolizumab) for the treatment of certain patients with high risk, non muscle invasive blade cancer (NMIBC)