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GSK says Ris-Rez meets primary endpoint in phase 3 lung cancer trial

ALN

GSK PLC on Friday announced that risvutatug rezetecan has delivered ‘meaningful’ survival data in a ‘pivotal’ trial for advanced or relapsed small-cell lung cancer.

The London-based pharmaceutical manufacturer holds exclusive global rights, excluding mainland China, Taiwan, Hong Kong and Macau, acquired from licensor Hansoh Pharmaceutical Group Co Ltd, to clinically develop and commercialise the drug, which is also known as Ris-Rez.

Hansoh conducted the trial in China, where it will use the data for regulatory submission.

Hansoh, GSK said, has announced that ‘pivotal’ phase 3 trial ARTEMIS-008 met its primary endpoint of overall survival from Ris-Rez. It said the drug demonstrated statistically significant and clinically meaningful improvements in OS when compared with topotecan, the current standard of care.

GSK added that Ris-Rezalso delivered consistent benefit across key secondary endpoints, including progression-free survival.

It also noted that it expects ‘pivotal data’ next year from the phase 3 EMBOLD SCLC-301 trial in relapsed extensive-stage small-cell lung cancer.

‘These results are an important milestone as the first positive phase 3 overall survival data for a B7-H3-targeted [antibody-drug conjugate] in any tumour type,’ GSK’s Global Head of Oncology, Research & Development Hesham Abdullah commented.

‘Together, with other data generated to date, they further support the potential of B7-H3 as a promising target across lung cancer and other solid tumours and reinforce our continued development of Ris-Rez to improve standard of care in areas of high unmet need.’

GSK shares were 0.7% higher at 1,972.50 pence on Friday afternoon in London.

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