Pfizer, Merck KGaA cement Bavencio bladder cancer win with OS data — while carving another niche in rare cancer
Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.
In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.
All 700 patients in the trial completed chemotherapy before getting randomized to either maintenance therapy with Bavencio or regular checking. Those on the drug arm saw mOS of 21.4 months, compared with 14.3 months on the comparator group.
Around one in 10 patients stopped the drug due to treatment problems, though the companies said side effects were in line with expectations.
“This highlights the potential benefits of a maintenance approach with avelumab in patients to prolong their lives following chemotherapy,” Thomas Powles, a study lead and professor of genitourinary oncology at Queen Mary, said in a statement.
The findings could be “practice-changing,” he added, especially considering these patients have cancer that has spread beyond the bladder.
The drug was already sanctioned, under accelerated approval, for use in patients following disease progression — an OK cemented by tumor response and duration of response back in 2017. Pfizer and Merck KGaA have submitted an application for a full OK.
With AstraZeneca’s PD-L1 Imfinzi failing to prove itself in a pivotal study (despite having an accelerated approval), they have few rivals to worry about.
That’s likely the same mindset that the two pharma giants are taking into gestational trophoblastic tumors, a kind of abnormal growth of cells inside a woman’s uterus. It’s a small Phase II study that enrolled only 15 patients, but researchers were encouraged by how Bavencio kept the disease from returning in eight of them. One patient even went on to have a healthy pregnancy.
The patients enrolled into the Phase II are resistant to monochemotherapy and must endure toxic chemo regimens. The main efficacy measure was the normalization of a hormone known as human chorionic gonadotropin.
No other immunotherapy has been tested in GTT patients before, scientists wrote in an abstract, but PD-L1 is expressed in all subtypes of this cancer.
A group of researchers in South Korea have also planned a similar study with Merck’s Keytruda, according to clinicaltrials.gov.