GSK Bets on Blood-Cancer Drug Comeback Amid Oncology Push

By Helena Smolak

GSK is betting that Blenrep--a blood-cancer treatment that U.S. drug regulators asked it to pull from the market in 2022--could get a second chance, part of a push by the British pharma giant to rebuild its oncology portfolio.

By year-end, the company aims to file an application for the U.S. Food and Drug Administration to approve Blenrep for use in combination with other drugs to treat multiple myeloma for patients whose first treatment didn't work or who had severe side effects. With FDA authorization, Blenrep would make a comeback in the U.S. nearly two years after the agency said the drug--then used alone--should be withdrawn when a trial revealed it didn't outperform an existing treatment.

"Blenrep coming back based on the [data from two recent clinical trials] validates our emerging presence in oncology," GSK's head of oncology research and development, Hesham Abdullah, said in an interview.

A decade ago, GSK swapped its oncology business with Novartis's vaccine franchise in a series of deals that reshaped the two companies. GSK has been taking steps in recent years to return to oncology, and its efforts to bring Blenrep to market reflect Chief Executive Emma Walmsley's push to reestablish the portfolio in this field.

In Blenrep, GSK sees a blockbuster candidate in a therapeutic area where none of its approved drugs have that status. The company forecasts that Blenrep's potential peak sales could top 3 billion pounds ($3.94 billion) annually.

While optimistic, analysts are more downbeat, forecasting the drug could generate 1.52 billion pounds--more than any other of GSK's oncology drugs--at its peak in 2032, according to consensus numbers provided by Visible Alpha. Analysts at Berenberg recently gave Blenrep a 70% chance of achieving global peak sales of 3 billion pounds.

"No doubt over the past few years we've come back to oncology, we've taken a measured and thoughtful approach about how to do that, to make sure we're going after areas where there is unmet need, " said Abdullah, GSK's oncology R&D head.

Abdullah joined GSK in 2019, after eight years at the oncology business of U.K. rival AstraZeneca, where he was vice president and global head of immuno-oncology.

Since GSK exited cancer drugs, its U.K. peer doubled down on oncology, which helped AstraZeneca become the country's most valuable publicly listed company. GSK's revenue last year stood at 30.33 billion pounds ($39.80 billion), against $45.81 billion for AstraZeneca, but AstraZeneca's market value of 183 billion pounds is nearly triple that of GSK's 67 billion pounds.

"We have to recognize that oncology continues to be a key area of unmet need," Abdullah said. "There is a focus from a GSK standpoint on patients and identifying unmet needs, hence why the organization came back to oncology."

The company found a gap in myeloma treatments, and is aiming to fill it with Blenrep. In June, GSK released data from a late-stage clinical study that showed the drug nearly halved the risk of disease progression or death compared to the standard of care in patients with multiple myeloma for whom the disease returned after a period of remission or who didn't respond to treatment.

The data built on an earlier trial of the drug, which also delivered positive results. The outcome of the study, disclosed in February, was the basis for the company's marketing-authorization application to the European Medicines Agency. The company is waiting for a decision from the European regulator, but it said on Friday that China had granted Blenrep a breakthrough therapy designation, which accelerates the development process.

In contrast to the trial that prompted the FDA to request the withdrawal of Blenrep from the U.S. market, GSK introduced it in combination with other drugs instead of as a monotherapy.

Investors have been watching Blenrep's development path due to its commercial potential.

When GSK released positive clinical-trial results for the drug in February, analysts at Citi raised their recommendation on the stock to buy from neutral, turning positive for the first time in seven years.

"While GSK will not be considered an oncology powerhouse for some time, the progress made with the portfolio is palpable," the analysts said in a note.

Write to Helena Smolak at helena.smolak@wsj.com

(END) Dow Jones Newswires

September 13, 2024 12:40 ET (16:40 GMT)

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