Immunotherapy for NMIBC! Key truda of MSD has entered the priority review in the United States!

December 4, 2019 / BIOON / -- cancer immunotherapy giant Merck & Co recently announced that the US FDA has accepted a supplementary biological product license application (SBLA) from keytruda (Chinese trade name: coreda, generic name: pembrolizumab, mAb) of PD-1 tumor immunotherapy and granted priority review The SBLA seeks to approve keytruda's new indications for the treatment of patients with high-risk muscle infiltrating prostate cancer (NMIBC), specifically as a single drug therapy for the treatment of BCG unresponsive, high-risk, CIS associated, with or without papillary carcinoma that does not qualify for cystectomy or has chosen not to undergo cystectomy (bladder resection) NMIBC patients with tumor The FDA's Oncology Advisory Committee (ODAC) will meet on December 17 to discuss the SBLA MSD expects the SBLA's prescription drug user fee Act (PDUFA) target date to be January 2020 based on the priority review Dr Roy Baynes, chief medical officer, senior vice president and director of global clinical development of Merck Research Laboratory, said: "the commitment of MSD to bladder cancer patients is unswerving, including promoting research to meet unmet medical needs Patients with high-risk, non muscle invasive bladder cancer sometimes make informed decisions, refuse to accept radical cystectomy, or do not meet the qualification of radical cystectomy in medicine; for patients who do not respond to BCG treatment, the current FDA approved non-surgical treatment program is limited We look forward to participating in the Advisory Committee meeting and continuing to work with keytruda as it reviews its supplementary applications " 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%) Article reference source: FDA grants priority review to Merck's supplementary biology license application (SBLA) for keytruda? (pemberizumab) in certain patients with high risk, non muscle invasive blade cancer (NMIBC)