Pharma titans Merck (MRK), Pfizer (PFE) and Astellas Pharma (ALPMY) are delivering an “enormous new hope” for patients with an aggressive form of bladder cancer.
On Saturday, the companies unveiled the results of their joint study during the European Society of Medical Oncology conference in Berlin. The combination of drugs Padcev and Keytruda cut the risk of recurrence, progression or death by 60%.
The study really “checked all the boxes,” Moitreyee Chatterjee-Kishore, Astellas’ head of oncology development, told Investor’s Business Daily.
“This is really, for us, pretty significant data for the patients,” she said. “It is an enormous new hope.”
Treating Bladder Cancer
Astellas and Pfizer are partnered on Padcev, an antibody drug conjugate approved to treat several types of cancer. Antibody drug conjugates, or ADCs, are like smart bombs for cancer. They aim toxic chemicals directly at targets on the cancer cells, limiting the damage to surrounding healthy tissue.
Merck brings Keytruda, its massively successful cancer treatment. Keytruda works by targeting the PD-1 cells that some cancer cells use to camouflage themselves from the immune system. By latching onto PD-1, Keytruda highlights the cancer cells, allowing the immune system to destroy them.
The study focused on patients with muscle-invasive bladder cancer who can’t tolerate cisplatin-based chemotherapy. Though this form of chemo is particularly effective, it also comes with the classic heavy-duty side effects associated with the drug class.
In one group, patients had their bladder and the nearby lymph nodes removed. In the other, patients first received three rounds of Padcev plus Keytruda. Then, they underwent the same surgery before receiving more rounds of the Padcev/Keytruda cocktail.
Patient who underwent surgery alone experienced their first “event” at a median of 15.7 months after surgery. In this case, the event would be relapse or death. But the median event-free survival hasn’t yet been discovered for the Padcev/Keytruda recipients. This means patients are living significantly longer without the fear of relapse or death, Chatterjee-Kishore said.
Marjorie Green, head of oncology clinical development for Merck, called the results “transformational,” in an email to IBD. Two years ago, at the same conference, she said the combination in bladder cancer treatment could eventually “rewrite textbooks.”
‘Leading Indicator’
Of particular note, the study also assessed overall survival, which is how long patients live before dying of any cause. In the surgery group, the median overall survival was 41.7 months. But it hasn’t been reached yet for patients who received the combination of Padcev and Keytruda.
“It is our hope in oncology that, that endpoint is not reached for several months, hopefully years,” Astellas’ Chatterjee-Kishore said. “That gives the patients the longer time for survival. Right now, if we look at the data, we see about 80% of patients (given Padcev and Keytruda) have been alive for at least two years, compared to about only 60% or so for those who received surgery alone.”
The study also looked at pathologic complete response. Pathologic complete response is when all signs of cancer have disappeared in tissue samples following treatment. More than half of patients in the Padcev/Keytruda group, 57.1%, met this bar vs. just 8.6% of those who received surgery alone.
Pathologic complete response is a “leading indicator” of whether a patient is going to eventually have a cancer relapse, Chatterjee-Kishore said.
“And for physicians, that’s a really important piece of evidence,” she said. “That would help them guide the patients and help them understand whether or not the treatment is going to be effective. … So, that’s very heartening for us.”
What’s Next?
The side effects line up with what you’d expect for Padcev and Keytruda, Chatterjee-Kishore said. Every patient reported a side effect. The most frequent were skin reactions, like itching and rash. A lower rate of side effects, 64.8%, occurred in the surgery group.
Chatterjee-Kishore noted there’s a big pool of patients with urothelial cancer. And Padcev stands a chance of helping many of them. It works by targeting the nectin-4 protein, which is highly expressed in bladder cancer cells.
“The goal of physicians, urologists and oncologists worldwide is to prevent the spread of disease,” she said. “Can we look for options that patients don’t need to lose their bladder? Can we delay surgery? Can we reduce the chance that they need surgery at all? Those are all aspirational goals that we are working towards, and those are very important to us.”
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
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