BLUE bluebird bio Inc

By Carlo Martuscelli

GlaxoSmithKline PLC (GSK) said Monday that its investigational treatment belantamab mafodotin produced positive results in patients with multiple myeloma who had undergone numerous other lines of therapy.

According to data from the Phase 3 clinical trial, 31% of patients who were administered the drug--also known as GSK2857916--responded to the treatment.

Patients enrolled in the Dreamm-2 study had an advanced form of the blood cancer, having undergone a median seven prior lines of treatment, the British drug maker said.

Head of oncology research Axel Hoos said the results burnished the company's in-house innovation. Glaxo sold its original cancer drug portfolio to Novartis in 2016. At the time, belantamab mafodotin was one of the early stage assets that was left behind.

Since then the company has moved back into oncology. Mr. Hoos said that while previously the company pursued a more cautious approach, preferring compounds with a moderate profile, it had pivoted to a high-risk and high-reward innovation-focused strategy--with antibody drug conjugate belantamab mafodotin one result of this shift.

Glaxo said it is initially pursuing approval from the U.S. Food and Drug Administration as a treatment for multiple myeloma in patients that have undergone four lines of therapy or more, with a decision expected at some point next year. A number of other trials are underway to secure indications in earlier stages of therapy.

Mr. Hoos said, if approved, the initial addressable patient population for belantamab mafodotin will number 10,000 in fourth line or more for the U.S., Europe and Japan, with the figure reaching 65,000 possible patients in first line.

However, the drug will be competing in what could become a crowded field. Earlier in the month, Bristol-Myers Squibb Co. (BMY), together with partner Bluebird Bio Inc. (BLUE), made public positive results from a Phase 2 study investigating their CAR-T therapy in patients with relapsed and refractory multiple myeloma.

Another approach, known as bispecific antibodies, is also being tested in multiple myeloma both by BMS and rival Regeneron Pharmaceuticals Inc. (REGN).

Mr. Hoos said while the overall response rate of CAR-T therapies in multiple myeloma had been high, duration of response wasn't stellar, and there were challenges with scalability and patient access.

Meanwhile, Glaxo's treatment was relatively easy to produce and to test in clinical trials, with rapid uptake expected, he said.

Belantamab mafodotin combines an cancer-targeting antibody with a toxic drug to destroy cancer cells.

"This is potentially the next big thing in multiple myeloma," Mr. Hoos added.

(END) Dow Jones Newswires

December 16, 2019 18:44 ET (23:44 GMT)

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