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AstraZeneca gets FDA OK for potential bladder cancer blockbuster

May 3, 2017

AstraZeneca (AZN) and its global biologics division, MedImmune (AZN), announced that the U.S. Food and Drug Administration (FDA) had granted accelerated approval to Imfinzi (durvalumab) for the treatment of locally advanced or metastatic urothelial carcinoma (mUC).

Specifically, the approval is for mUC patients whose disease has progressed during or after platinum-containing chemotherapy, or whose cancer has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. The drug is also in a Phase III DANUBE trial as a potential first-line treatment in urothelial carcinoma as a monotherapy and in combination with tremelimumab.

Imfinzi is a human monoclonal antibody against PD-L1. It is also being tested in unresectable and metastatic bladder cancer as a monotherapy and in combination with tremelimumab, a checkpoint inhibitor targeting CTLA-4.

“We are excited to offer Imfinzi as a breakthrough therapy for patients with locally-advanced or metastatic bladder cancer,” said Pascal Soriot, AstraZeneca’s chief executive officer, in a statement. “Imfinzi is the cornerstone of our extensive Immuno-Oncology program, in development across many tumor types, as monotherapy and in combination. The first approval for Imfinzi is an important milestone in our return to growth and brings us another step closer to our goal of redefining the way cancer is treated.”

It’s good timing for the company, which has recently lost patent protection for blockbusters like Crestor, for cholesterol, and Nexium, for heartburn. Although bladder cancer is considered a relatively small market, AstraZeneca is slow to enter the immuno-oncology market compared to Bristol-Myers Squibb (BMY) and Roche (RHHBY). Imfinzi is being studied in untreated lung cancer, which would be a significantly bigger market. Trial results for that are expected in June or July.

Seamus Fernandez, an analyst with Leerink, notes that the global bladder cancer market is about $2.3 billion, and Imfinzi is likely to only nab about 10 percent of it, despite AstraZeneca predicting peak sales in all cancers at $6.5 billion.

Imfinzi will have a price tag of around $15,000 per month wholesale.

Alistair Campbell, an analyst at Berenberg, stated in April, “As a reminder, the AstraZeneca turnaround story largely hinges on what happens to its oncology portfolio.”

James Skinner, writing for TheStreet, said, “Durvalumab is a cornerstone of Astra’s oncology portfolio, which could either make or break expectations for the Anglo-Swedish pharma giant’s top line over the coming years, with analysts forecasting ‘all application’ sales of between $1.5 billion and $2.3 billion per year by 2020.”

The FDA’s accelerated approval is typically based on positive early clinical trial data for a disease with few treatment options with the added safety net of ongoing larger clinical trials. This accelerated approval was based on data from Study 1108, a Phase I/II clinical trial that looked at the safety and efficacy of Imfinzi in patients with locally advanced or metastatic urothelial carcinoma of the bladder.

In the trial, the drug showed rapid and durable responses, with an objective response rate (ORR) of 17 percent in all patients who could be evaluated, regardless of PD-L1 status. It also has an ORR of 26.3 percent in patients with PD-L1 high-expressing tumors.

The PD-L1 expression was determined by the VENTANA PD-L1 (SP263) Assay, developed by Ventana Medical Systems (VMSI), a member of the Roche Group, and approved by the FDA. The trials have indicated that patients with high PD-L1 levels are likely to do well on Imfinzi. However, the test is not required for use of the drug.

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