GSK cancer drug candidate gets another breakthrough designation
Date: Tuesday 07 Jan 2025
(Sharecast News) - GSK announced on Tuesday that its investigational antibody-drug conjugate GSK'227 has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for treating relapsed or refractory osteosarcoma in patients who had progressed after at least two prior lines of therapy.
The FTSE 100 pharmaceuticals giant said the designation, aimed at expediting the development of treatments for serious conditions, reflected promising early data suggesting substantial improvement over current options.
It said the recognition followed earlier regulatory milestones for GSK'227, including priority medicines (PRIME) designation by the European Medicines Agency and a separate FDA breakthrough therapy designation for relapsed or refractory extensive-stage small-cell lung cancer in 2024.
The osteosarcoma designation was supported by data from the ARTEMIS-002 study, a phase two trial involving over 60 patients, including 42 with osteosarcoma.
Results from the trial were presented at the 2024 American Society of Clinical Oncology Annual Meeting.
GSK'227 targets B7-H3, a protein expressed in various cancers, and is being developed under a global clinical and commercialisation agreement with Hansoh Pharma.
GSK recently launched a global phase one trial as part of a broader plan to advance the drug toward regulatory approval.
Osteosarcoma, a rare and aggressive bone cancer primarily affecting children and young adults, currently has limited treatment options, especially for relapsed or refractory cases.
With no FDA-approved therapies available for patients who progress after two prior lines of treatment, GSK'227 had the potential to address a critical unmet need in the patient population.
The disease accounts for less than 1% of all new cancer diagnoses in the US, with an annual incidence of 3.3 cases per million, but remained the most common primary bone cancer.
"This latest regulatory designation for GSK'227 exemplifies the potential of our targeted ADC in patients with difficult to treat cancers," said Hesham Abdullah, senior vice-president and global head of oncology for GSK.
"For patients with relapsed or refractory osteosarcoma, there is an urgent unmet medical need with no approved treatment options once the cancer returns a second time, and chemotherapy provides limited benefit in this setting."
At 0819 GMT, shares in GSK were down 0.67% at 1,340p.
Reporting by Josh White for Sharecast.com.
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