Merck KGaA, Pfizer's Bavencio set to seal bladder cancer approval after confirmatory trial scores
Bavencio could use the win.
More than two years after its makers — Germany’s Merck KGaA and Pfizer — secured FDA approval for a form of bladder cancer, the companies unveiled that the confirmatory study testing the PD-L1 inhibitor had performed as expected, helping patients live longer as a maintenance treatment versus standard-of-care.
The drug was granted accelerated approval on the basis of tumor response and duration of response in May 2017 in patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has progressed during or after platinum-containing chemotherapy. On Monday, the companies said that data from the confirmatory JAVELIN Bladder 100 trial showed patients treated with Bavencio lived significantly longer than those who received standard care.
A statistically significant improvement in overall survival was demonstrated in the Bavencio arm in each of the co-primary populations: all randomized patients and patients with PD-L1–positive tumors, the company added, without disclosing the numbers. The data will be handed over to the FDA.
Bavencio was late to the checkpoint inhibitor game. Merck’s market-leading Keytruda and Bristol-Myers’ pioneering Opdivo were the first two PD-1/L1 drugs to make the cut, and have since scored various approvals across immuno-oncology and now reap in billions in sales. Regeneron, Roche and China-based drug developers also have their own checkpoints — PARP inhibitors are also the mix.
Last September, Cowen analysts shaved their 2024 projections for Bavencio by $170 million to $480 million, citing flat growth and relatively few catalysts ahead. In comparison, Opdivo is expected to generate a meaty $12.4 billion that year, and king Keytruda a hefty $20.6 billion, the analysts estimated.
Bavencio, for which Pfizer paid $850 million upfront in 2014 to partner with Merck KGaA on, has had some serious setbacks in its quest to make a mark. The partners were forced to admit defeat in ovarian cancer in March last year after three straight trial failures. Months later in November, the drug also fizzled as a first-line maintenance therapy for gastric cancer patients, years after faltering in a gastric cancer study to improve overall survival. In 2018, Bavencio also botched a key study in the lucrative field of lung cancer.
The companies, however, did have some luck in kidney cancer. Bavencio was granted approval in May 2019 in combination with Pfizer’s tyrosine kinase inhibitor Inlyta for use as a frontline therapy for renal cell carcinoma, after late-stage data showed the combination demonstrated a significant progression-free survival benefit. It is also approved for use in Merkel cell carcinoma.
UC accounts for about 90% of all bladder cancer cases. When bladder cancer is metastatic, the five-year survival rate is 5%, according to American Cancer Society estimates.