Dive Brief:

• Padcev, an antibody-drug conjugate Pfizer acquired in its $43 billion buyout of Seagen, met the primary goal of a bladder cancer trial, helping people ineligible for chemotherapy when used in combination with Merck & Co.’s Keytruda before and after surgery, the companies said Tuesday.
• The drugmaker said it will discuss approval applications with health regulators, which could expand Padcev’s use in bladder cancer into the so-called neo-adjuvant and adjuvant settings. Padcev is currently used with Keytruda in locally advanced and metastatic disease that can’t be operated on, and alone in people whose disease has progressed after treatment.
• Padcev, which is co-promoted with Astellas in the U.S., is a fast-growing drug in Pfizer’s oncology business — on track to record around $2 billion in sales in 2025. Pfizer has been under pressure because of declining revenue from its COVID-19 vaccine and drug, and is looking to new products to lift sales.

Dive Insight:

The Padcev and Keytruda combination showed at an early data check that it prevented the disease’s return as well as helped people live longer following surgical removal of the bladder, when compared to surgery alone. The company didn’t disclose specific numbers from the trial, but said they would be shared at an upcoming medical meeting.

The trial enrolled about 600 people with bladder cancer that had grown into the muscle surrounding the organ but hadn’t spread elsewhere. Participants were either ineligible to receive chemo or declined.

They were randomized into three groups: people who had had their bladders removed and were given a placebo, people treated with Keytruda and Padcev before and after surgery, and people who got Keytruda before and after surgery. The study’s plan didn’t include a comparison between the combination arm and the Keytruda-plus-surgery arm, but did include a comparison between Keytruda-plus-surgery and surgery alone.

Surgery alone can help around 60% of people who receive it live five years or more after the procedure, and chemo before surgery cut the risk of death by 25% when compared to surgery alone. Keytruda, meanwhile, showed that it helped stave off disease when used following surgery, but didn’t help people survive longer.

The new study’s results “mark the first time a systemic treatment approach, used before and after surgery, significantly extended survival over standard-of-care surgery in this population, demonstrating the potential of this combination to address a critical unmet patient need,” Christof Vulsteke, head of Integrated Cancer Center Ghent in Belgium and the study’s principal investigator, said a statement provided by Pfizer.

Padcev consists of an antibody that targets Nectin-4, a surface protein expressed on bladder cancer cells, and a chemo toxin. After binding to Nectin-4, the drug releases the toxin and kills the target malignant cell.

Opdivo, a Keytruda competitor developed by Bristol Myers Squibb, is approved for treatment of bladder cancer following surgery. Another drug in the same class, AstraZeneca's Imfinzi, is approved for post-surgical use in combination with chemo.