Ahead of PDUFA August date, Astellas and Seagen sweeten Padcev’s presentation with new data – Endpoints News
Astellas and Seagen made waves in 2019 when they received conditional approval for their therapy targeting nectin-4 Padcev in urothelial cancer. Now that the FDA is considering full approval and label extension, companies have new data to share ahead of their August PDUFA date.
Padcev was initially OK in the locally advanced or metastatic setting for patients who had previously received a PD-1 or PD-L1 inhibitor and platinum chemotherapy. The new analysis, however, comes from a second cohort of phase II patients who were medically unable to take cisplatin chemotherapy.
In that group, 51% of patients saw their tumors shrink after a median of 16 months, Astellas and Seagen said Wednesday before ASCO. And participants lived a median of 6.7 months without their cancer getting worse.
“Even if you think about some of the benefits of checkpoint inhibitors, it’s heartbreaking how much unmet need there is in this segment,” said Andrew Krivoshik, Senior Vice President and Head of Therapeutics. Astellas oncology News Endpoints.
In the phase II trial, called EV-201, 22% of patients in cohort 2 achieved a complete response, with a median duration of response of 13.8 months. The median overall survival was 16.1 months.
Astellas and Seagen were granted priority review in April for this new subset of patients. Regulators have said they will decide on the new indication and the company’s offer for full approval by August 17.
Padcev, the first such antibody-drug conjugate, works by binding to Nectin-4, a highly expressed cell surface protein in bladder cancer. A specific chemotherapy agent is then released to kill the cells.
Confirmatory data read in February showed that Padcev – when given after platinum-based chemotherapy and previous PD-1 treatment – prolonged patients’ lives by an average of 12.9 months compared to nine months for a chemo control. Key data from September showed a 30% reduction in the risk of death (p = 0.001) and a 39% reduction in the risk of disease progression or death (p
And the partners don’t stop there. The Astellas and Seagen teams are looking to bring Padcev to the early stages of urothelial cancer, including with Merck’s Keytruda. Data from this trial, a phase Ib / II, was also released on Wednesday, showing that the combo led to an objective response rate of 73.3%.
A total of 15% of patients experienced a complete response, according to drug makers, and patients lived a median of 12.3 months without their cancer getting worse. With longer follow-up, the researchers noted a median duration of response of 25.6 months and a median overall survival of just over 26 months.
Padcev performed better than expected in its first quarter in the market, achieving sales of $ 34.5 million.