The US FDA has accepted and granted priority review to a supplementary biologicals licensing application (SBLA) from keytruda, an anti-PD-1 therapy, Merck said recently
The SBLA applied for approval of keytruda as a single drug therapy for specific high-risk non muscle invasive bladder cancer (NMIBC) patients, specifically: NMIBC patients who are not eligible for cystectomy or who have chosen not to undergo cystectomy, who are non responsive, high-risk, with in situ cancer (CIS), with or without papillary lesions
The FDA Cancer Drug Advisory Committee will hold a meeting on December 17 to discuss the SBLA
MSD expects FDA to make a final review decision in January 2020 based on the priority review
This new indication application is based on the results of the open label, multi cohort phase II clinical study keynote-057 (nct02625961)
This study was carried out in 260 patients with NMIBC at high risk who did not respond to the current standard therapy BCG and did not meet or refuse radical cystectomy
They were divided into two groups: Patients with cis or CIS + papillary lesions (queue a, n = 130), and patients without CIS (queue B, n = 130)
Patients in both groups were treated with keytruda (200mg fixed dose intravenously once every three weeks) until disease recurrence, disease progression, unacceptable toxicity, or in patients without disease progression until 24 months
The interim analysis data from group A was published at the ESMO annual meeting in 2018
The data showed that the complete remission (CR) rate was 38.8% (95% CI: 29.4-48.9; n = 103) when keytruda was treated for 3 months
According to Kaplan Meier's method, 80% of the patients who reached CR at 3 months had CR lasting for 6 months or longer; at 14.0 months of median follow-up, the duration of median remission in CR patients had not reached (0 + to 14.1 +)
In this study, keytruda's safety was consistent with that in previous single drug treatment studies
Bladder cancer 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
Keynote-057 study showed that keytruda single drug treatment achieved nearly 40% complete remission rate, which is very encouraging for patients with refractory high-risk NMIBC who are not qualified to accept or refuse to accept cystectomy
Keytruda is an anti-PD-1 therapy that helps detect and fight cancer cells by improving the ability of the body's immune system
MSD has the largest clinical research project in immunooncology in the industry
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 held its first investor day meeting in five years and said that keytruda's approved treatment indications are expected to more than double in the next five years.
