Bavencio from Merck KGaA, Pfizer encounters yet another trial setback
Just when Bavencio’s prospects were beginning to look a little brighter after positive confirmatory trial readout in January, the therapy has fizzled in another oncology indication.
The late-stage 697-patient trial was testing the use of Bavencio in combination with chemoradiotherapy (CRT) against standard-of-care CRT in patients with untreated, locally-advanced squamous cell carcinoma of the head and neck.
But the drug’s makers Germany’s Merck KGaA and Pfizer accepted the recommendation of an independent data monitoring committee to cease the trial, on the basis that the PD-L1 inhibitor was not likely to induce a statistically significant improvement on the main goal of progression-free survival.
Detailed data are still to come.
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 in 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, 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 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. In January, 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.
The companies have also had some success 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.