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Merck KGaA, Pfizer’s Bavencio improves survival in bladder cancer

Confirmatory trial strengthens claim in therapy area

Merck KGaA

Nearly three years after winning approval in bladder cancer, Merck KGaA and Pfizer’s immuno-oncology drug Bavencio has demonstrated overall improved survival in a confirmatory phase 3 trial. 

In May 2017, Bavencio (avelumab) claimed approval as a second-line treatment in patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease progressed during or following platinum-containing chemotherapy.

That approval was based on Bavencio ability to create tumour response and duration of response in advanced UC patients.

UC is a large market, accounting for around 90% of all bladder cancer diagnoses. When it reaches the metastatic stage, the five-year survival rate is 5%.

The data from the phase 3 JAVELIN Bladder 100 trial has confirmed that Bavencio statistically improves survival in its approved patient population. Importantly for Merck KGaA and Pfizer, the drug is the first immunotherapy to achieve improvement in overall survival in the first-line setting in bladder cancer.

“Our unique maintenance approach with Bavencio has significantly prolonged survival for patients with locally advanced or metastatic urothelial carcinoma in this trial,” said Luciano Rossetti, head of global R&D, EMD Serono.

Although Merck KGaA and Pfizer have not revealed the exact details of the overall survival data, the partners have disclosed that the checkpoint inhibitor demonstrated improvement regardless of PD-L1 status.

The updated overall survival data could help Bavencio extend into the first-line setting, which could aid sales growth of the drug in an area with tough competition.

Merck’s Keytruda (pembrolizumab), Bristol-Myers Squibb’s Opdivo (nivolumab), Roche’s Tecentriq (atezolizumab) and AstraZeneca’s Imfinzi (durvalumab) are all approved for use in bladder cancer, albeit in differing settings.

Bavencio is also approved for the treatment of adults and paediatric patients 12 years and older with metastatic Merkel cell carcinoma, and in combination with tyrosine kinase inhibitor Inlyta (axitinib) as a first-line treatment of patients with advanced renal cell carcinoma.

The extension into the earlier indication in bladder cancer is vital for Bavencio, which has been plagued by a number of trial failures in various cancer types, including gastric and lung cancer.

Meanwhile, rival PD-1/L1 drugs have gone on to pick up long lists of approvals, including class leader Keytruda which is indicated for use in over ten cancer types.

Article by
Lucy Parsons

7th January 2020

From: Research

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