AstraZeneca has secured another expansion of its Imfinzi for use in cancer patients before and after surgery. This time, a groundbreaking FDA approval makes the PD-L1 inhibitor the first immunotherapy to win a perioperative label in muscle-invasive bladder cancer (MIBC).
The FDA specifically approved the therapy for use in MIBC patients alongside chemotherapies gemcitabine and cisplatin ahead of bladder-removing surgery and then on its own following the procedure, AZ said Monday.
“Today’s approval for Imfinzi represents a paradigm shift, bringing the first perioperative immunotherapy to patients in the US with muscle-invasive bladder cancer and addressing a significant need for better treatment options,” AstraZeneca’s head of the oncology hematology business unit, Dave Fredrickson, highlighted in a company statement.
The FDA based its decision on the company’s phase 3 Niagara trial. At an interim analysis, the Imfinzi regimen prompted a 32% reduction in the risk of a basket of negative events, including failure to move on to surgery, disease progression, recurrence or death compared with chemotherapy alone. While an estimated median event-free survival was not yet reached for the Imfinzi arm, some 67.8% of patients in that group were event-free by two years compared with 59.8% in the chemotherapy arm.
Imfinzi also made headlines with that study by reducing the risk of death by 25%, making it the first PD-1/L1 inhibitor to deliver a survival win for MIBC patients.
At two years, an estimated 82.2% of patients treated with Imfinzi before and after surgery were still alive, compared with 75.2% of those who took chemotherapy alone. The survival win shows the “potential of this innovative perioperative regimen to become a new standard of care in this setting,” Fredrickson noted.
MIBC isn’t Imfinzi’s first perioperative approval. Last year, AstraZeneca faced FDA scrutiny over a perioperative trial design for Imfinzi in early-stage resectable non-small cell lung cancer (NSCLC). The agency had raised concerns that the trial couldn’t discern the effectiveness of each phase of treatment and that such treatment regimens run the risk of toxicities “due to overtreatment without additional clinical benefit.”
While an external expert panel voted that future trials in the treatment setting should be designed to specifically assess the effect of each treatment phase, Imfinzi’s data package was enough to bag an approval the following month.
Bladder cancer is a bit of a different beast than NSCLC, where the FDA has previously approved PD-1/L1 inhibitors as either neoadjuvant or adjuvant treatments, chief medical officer and oncology chief development officer at AstraZeneca Cristian Massacesi told Fierce Pharma in an interview last year.
While AZ is the first to walk the perioperative road in MIBC, Bristol Myers Squibb’s Opdivo had in 2021 obtained an FDA go-ahead as a postsurgical adjuvant treatment for patients with bladder cancer who are at high risk of recurrence after radical resection.
The current standard of care for the 20,000 people in the U.S. who were treated for MIBC last year is pre-surgical chemotherapy followed by bladder removal surgery. But some 50% of patients experience disease recurrence after surgery, making treatment options to prevent this a “critically needed,” according to AZ.
Imfinzi has already been approved in this use in Brazil and regulatory filings are under review in Europe, Japan and other countries.