Padcev, which happens to be an antibody drug conjugate that Pfizer has acquired in its $43 billion buyout of Seagen, has gone on to meet the primary objective of a bladder cancer trial, thereby helping people who were ineligible for chemotherapy when used in combination with Keytruda from Merck & Co. both before and after surgery. The drugmaker has said that it will discuss approval applications along with health regulators, which could also expand use of Padcev in bladder cancer within the so-called neoadjuvant as well as adjuvant scenarios.
It is well to be noted that Padcev in bladder cancer is at present used with Keytruda in certain locally advanced as well as metastatic diseases, which cannot be operated on, and also alone in people whose disease has gone on to progress even after treatment.
Apparently, Padcev, which happens to be co-promoted with Astellas in the US, happens to be a fast-growing drug within the oncology business of Pfizer and is on track to record almost $2 billion in sales in 2025. Interestingly, Pfizer has been under pressure due to the declining revenue from its COVID-19 vaccine as well as drugs and is now looking for certain new products so as to accelerate its sales.
The Padcev and Keytruda combination went on to show an early data check that it safeguarded the return of the disease and also helped people live longer following their surgical removal of the bladder as compared to the surgery alone. However, the company has not disclosed the specific numbers from the trial, but it is said that they will be shared at an upcoming medical meeting soon.
It is well to be noted that the trial went on to enroll almost 600 people having bladder cancer, which had grown into the muscle that surrounded the organ but had not spread anywhere else. Participants were either eligible to receive the chemo, or they went on to decline it.
Apparently, the participants were randomized into three groups – people who had their bladder removed and were offered a placebo, people who got treated with Keytruda as well as Padcev, Before and after the surgery, and people who only got Keytruda before and after the surgery.
It is well to be noted that the plan of the study did not include any comparison between the combination arm and the Keytruda-plus-surgery arm, but it did include a comparison between Keytruda-plus-surgery and surgery alone.
Interestingly, surgery alone can help almost 60% of people who go on to receive it live five years or more after the procedure, and the chemotherapy before the surgery can cut the risk of death by almost 25% as compared to only surgery. Keytruda, on the other hand, showed that it helped stave off the disease after being used post-surgery, but it did not help people survive for long.
According to the head of the integrated Cancer Centre, Ghent, in Belgium, and also the principal investigator of the study, Christof Vulsteke, the results of the new study mark the first time that a systemic treatment approach, which was used before and after surgery, prominently extended the survival rate over the standard of care surgery in this population, thereby demonstrating the potential of the combination in order to address crucial unmet patient requirements.
It is worth noting that Padcev goes on to consist of an antibody that targets Nectin-4, which is a surface protein that gets expressed on bladder cancer cells, and a chemotoxin. Post binding to Nectin-4, the drug releases the toxin and thereafter kills the target malignant cell.
A Keytruda competitor called Opdevo, which is developed by Bristol Myers Squibb, is also approved for treatment of bladder cancer following the surgery. There is another drug in the same class named Imfinzi from AstraZeneca, which has gotten its approval for post-surgical usage but in combination with chemotherapy.
