BAVENCIO was approved by the US Food and Drug Administration (FDA), for the treatment of patients with locally advanced or metastatic UC

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Merck and Pfizer announced positive results from Phase III JAVELIN Bladder 100 trial of BAVENCIO. (Courtesy: Pfizer Inc.)

Merck’s biopharmaceutical business, EMD Serono, and Pfizer announced the positive results of the Phase III JAVELIN Bladder 100 trial of BAVENCIO (avelumab) for the treatment of urothelial carcinoma (UC).

The JAVELIN Bladder 100 is a Phase III, multicentre, randomised, open-label, clinical study of BAVENCIO, in combination with best supportive care (BSC) as first-line maintenance treatment for metastatic UC—a better option when compared to BSC alone.

According to the company, UC accounts for 90% of all bladder cancers, and the disease becomes difficult to treat when it spreads through the layers of the bladder wall. Currently, for patients in the advanced stage of the disease, combination chemotherapy is the first-line standard of care.

EMD Serono’s Global R&D Head Luciano Rossetti stated: “Our unique maintenance approach with BAVENCIO has significantly prolonged survival for patients with locally advanced or metastatic urothelial carcinoma in this trial. We believe this approach could become part of routine clinical practice, as these results are a major advance on the existing standard of care.”

Pfizer will submit the study results to the US (FDA) and other health authorities

JAVELIN Bladder 100 trial results showed that patients with untreated metastatic UC, who received BAVENCIO and BSC as first-line maintenance therapy, lived significantly longer than those who received BSC only. The study has reached its primary end-point of overall survival (OS).

In addition, the JAVELIN Bladder 100 clinical study has demonstrated a consistent safety profile for BAVENCIO, similar to that of JAVELIN monotherapy clinical development programme.

In 2017, BAVENCIO was approved by the US Food and Drug Administration (FDA) for the treatment of patients with metastatic UC, with disease progression during or following chemotherapy, or within 12 months of treatment with chemotherapy.

Pfizer Oncology’s Chief Development Officer of Global Product Development, Chris Boshoff assured: “BAVENCIO is the first immunotherapy to demonstrate in a clinical trial a statistically significant improvement in overall survival as a first-line treatment for patients with advanced urothelial carcinoma.

“These latest positive data from the JAVELIN clinical development program add to the body of evidence for BAVENCIO in the treatment of genitourinary cancers, and we are looking forward to discuss these results with the health authorities.”