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GSK reports positive myeloma trial results, progresses vaccine applications

(Sharecast News) - GSK reported progress in its trial of a myeloma treatment on Tuesday, as well as regulatory progress around its shingles vaccine in China and its RSV vaccine in the United States.

The FTSE 100 pharmaceuticals giant unveiled the results of its interim analysis of the 'DREAMM-7' phase three head-to-head trial, evaluating the efficacy of 'Blenrep', or belantamab mafodotin, in combination with bortezomib plus dexamethasone, or 'BorDex', versus daratumumab plus BorDex for treating relapsed or refractory multiple myeloma.

It said the findings, to be presented at the American Society of Clinical Oncology (ASCO) Plenary Series on 6 February, revealed a remarkable improvement in progression-free survival (PFS) with the belantamab mafodotin combination.

Notably, the combination exhibited a 59% reduction in the risk of disease progression or death compared to the daratumumab combination.

With a median follow-up of 28.2 months, the PFS with belantamab mafodotin reached 36.6 months, while it stood at 13.4 months with daratumumab.

The PFS advantage was consistent across various patient subgroups, including those with high-risk cytogenetics and lenalidomide refractory cases.

GSK said the safety profile of the combination was consistent with the known profiles of its individual components.

It said the belantamab mafodotin combination also demonstrated significant improvements in secondary efficacy endpoints, such as complete response rate, minimal residual disease (MRD) negativity rate, and median duration of response (DOR).

Additionally, the interim analysis hinted at a clinically meaningful overall survival (OS) trend, indicating a 43% reduction in the risk of death, although statistical significance had not yet been reached.

Further overall survival follow-up and analyses were planned to validate the results.

"The substantial progression-free survival benefit and strong overall survival trend compared to a daratumumab standard of care combination reinforce our belief in the potential for belantamab mafodotin used in combination to redefine the treatment of multiple myeloma at or after first relapse," said Hesham Abdullah, GSK's senior vice-president and global head of oncology research and development.

"We plan on sharing these results with health authorities worldwide."

Elsewhere, GSK announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) had accepted the regulatory application for 'Shingrix' to expand its use in China.

Initially approved in 2019 for adults aged 50 and over, Shingrix is a non-live, recombinant subunit adjuvanted vaccine designed to prevent shingles.

The new application targeted adults aged 18 years and over who were at an elevated risk of developing shingles.

Shingles is estimated to affect up to one in three people globally, with risk factors including age and immunodeficiency, along with other chronic conditions like COPD, diabetes, and asthma.

In China, there were around six million cases of shingles each year, with those at increased risk, including immunocompromised individuals, facing over three times the risk compared to the general population.

The regulatory application was supported by data from six clinical trials involving patients aged 18 and over who had undergone recent blood-forming cells (stem cell) transplantation, kidney transplant, or had blood cancer, solid tumour, or HIV.

Finally, GSK disclosed its application for an extension of the indication of its adjuvanted respiratory syncytial virus (RSV) vaccine to include adults aged 50 to 59 at increased risk for RSV disease.

Currently, Arexvy is approved in the US for use in adults aged 60 and over to prevent lower respiratory tract disease (LRTD) caused by RSV.

The application, submitted to the US Food and Drug Administration (FDA) under priority review, was supported by positive results from a phase III trial evaluating the vaccine's immune response and safety in adults aged 50 to 59, particularly those with underlying medical conditions that increase their susceptibility to RSV-LRTD.

GSK said it used a priority review voucher to expedite the review process, with the FDA expected to make a regulatory decision by 7 June.

At 0807 GMT, shares in GSK were down 0.01% at 1,662.4p.

Reporting by Josh White for

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