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EMA starts review of Bavencio in first-line bladder cancer

Results from phase 3 study may lead to possible approval next year


Merck KGaA and Pfizer have lost no time in filing for approval of their checkpoint inhibitor Bavencio in a new bladder cancer indication in Europe, free of competition from other drugs in the class.

The EMA has started its review of Bavencio (avelumab) as a first-line maintenance treatment for  locally advanced or metastatic urothelial carcinoma (UC) – the most common form of bladder cancer – setting up a possible approval next year.

The review is based on results from the phase 3 JAVELIN Bladder 100 study, which showed a 31% improvement in overall survival (OS) for Bavencio plus supportive care as first-line maintenance treatment following induction chemotherapy, compared to supportive care alone.

Patients in the Bavencio treatment group had a median OS of 21.4 months, compared to 13.3 months for the control group, with the survival benefit observed regardless of the levels of the PD-L1 biomarker in cancer cells.

After 12 months, 71% of patients on Bavencio maintenance were alive compared to 58% of patients receiving supportive care.

Bavencio is already approved as a second-line treatment for bladder cancer after platinum-based chemotherapy, getting a green light for this indication from the FDA in 2017.

In that indication it has to compete with other checkpoint inhibitors, including Merck & Co/MSD’s market-leading Keytruda (pembrolizumab), Bristol-Myers Squibb’s Opdivo (nivolumab), AstraZeneca’s Imfinzi (durvalumab) and Roche’s Tecentriq (atezolizumab).

Keytruda is also approved for first-line use in patients who aren’t eligible for chemo, but as yet no checkpoint inhibitors have approval for the first-line maintenance use in UC.

The indication could help to kickstart sales of Bavencio, which have lagged behind its rivals to date partly because of failed trials in multiple other tumour types, including stomach, head and neck, and lung cancer.

Merck and Pfizer’s drug made just $114m last year from its approved uses in UC, kidney cancer and Merkel cell carcinoma, all categories where it has to compete with class leader Keytruda, although the latter drug has just failed to move the needle as a first-line UC treatment in combination with chemo.

Bavencio has been granted breakthrough status in the US for the first-line maintenance indication by the FDA, which started its review of the JAVELIN Bladder 100 data in April.

The US regulator is reviewing the drug under its Real-Time Oncology Review (RTOR) programme, which means a verdict should come quickly.

Article by
Phil Taylor

23rd June 2020

From: Regulatory



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