Please login to the form below

Not currently logged in

Seattle Genetics makes case for Padcev plus Keytruda in first-line bladder cancer

Hopes to extend the antibody drug conjugate's use into the earlier setting

Seattle Genetics

Seattle Genetics and partner Astellas have reported positive results from an early clinical trial of their antibody drug conjugate Padcev in combination with Merck & Co/MSD’s Keytruda in first-line bladder cancer.

At the tail-end of last year, Seattle and Astellas scored US approval for Padcev (enfortumab vedotin) for the treatment of locally-advanced or metastatic urothelial carcinoma – the most common form of bladder cancer.

Padcev is made up of an antibody targeting Nectin-4, a cell surface protein which is highly expressed in bladder cancer, with a drug that kills the cancer cell – monomethyl auristatin E.

It was indicated for use only in adults who have previously been treated with chemotherapy, as well as immunotherapy with a PD-1/PD-L1 inhibitor, such as Keytruda (pembrolizumab).

Now, Seattle and Astellas are looking to expand the use of the ADC into earlier lines of therapy, and they are making their case for a combination therapy of the drug.

The initial results from the phase 1b/2 EV-103 trial were presented at ESMO back in September, which involved 45 metastatic urothelial cancer patients who were previously untreated and were ineligible for cisplatin based chemotherapy.

This most recent update revealed that the Padcev/Keytruda combination shrank tumours in the majority of patients, with an objective response rate of 73.3% after a median follow-up of 11.5 months. Out of those who experienced ORR, 15.6% experienced a completed response and 57.8% of patients experienced a partial response.

On top of that, the median progression-free survival was 12.3 months and the 12-month overall survival (OS) rate was 81.6%, although median OS had not yet been reached.

Keytruda won approval for first-line bladder cancer on the back of its KEYNOTE-052 trial, which demonstrated an ORR of 29% in 310 patients, with 7% experiencing a complete response and 22% partial responses. In comparison, the Padcev combination seems to top Keytruda alone, at least with this updated early-stage data.

According to Seattle, the safety and tolerability of the combination treatment was manageable, although 58% of patients experienced a treatment-related adverse event greater than or equal to grade 3. However, none of the adverse events of clinical interest were greater than grade 5.

"These updated data are encouraging and provide support for the recently initiated phase 3 trial EV-302 that includes an arm evaluating Padcev in this platinum-free combination in the first-line setting," said Roger Dansey, chief medical officer at Seattle Genetics.

Padcev is Seattle's second marketed drug after its lymphoma therapy Adcetris (brentuximab vedotin), which is expanding its business into the solid tumour category.

Article by
Lucy Parsons

12th February 2020

From: Research



Featured jobs

Subscribe to our email news alerts


Add my company

Hamell is a full-service agency with a clear focus on delivering evidence-based, sustained behaviour change. So, whether you are looking...

Latest intelligence

How will the Tories’ historic win shape the NHS?
Paul Midgley and Oli Hudson, of Wilmington Healthcare, explore the impact of December’s General Election result on 2020 and beyond...
CSR 'Christmas Spirit' 2019
OPEN Health champions CSR over Christmas by giving back to the community and increasing our activities and efforts...
Spotlight interview: 15 minutes on Independent Medical Education
Celeste Kolanko, Managing Director of Liberum, OPEN Health takes 15 minutes to answer some key questions on independent medical education....