GSK's Cancer Portfolio Gains Momentum with Regulatory Successes for Dostarlimab and GSK'227
Key Insights
Dostarlimab plus chemotherapy receives positive CHMP opinion for expanded approval in primary advanced or recurrent endometrial cancer (search), including mismatch repair proficient/microsatellite stable tumors.
Dostarlimab also gains FDA Breakthrough Therapy Designation for locally advanced mismatch repair deficient/microsatellite instability-high rectal cancer (search), showing 100% disease-free response in treated patients.
GSK's B7-H3 (search)-targeted antibody-drug conjugate, GSK’227 (search), receives EMA PRIME designation for relapsed extensive-stage small-cell lung cancer (search), based on promising early clinical data.
GSK PLC has announced significant regulatory advancements for its oncology pipeline, including positive updates for dostarlimab (Jemperli) and GSK’227 (search). These developments highlight GSK's commitment to addressing unmet needs in cancer treatment across various tumor types.
Dostarlimab's Potential Expansion in Endometrial Cancer
The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the expansion of dostarlimab's approval, in combination with chemotherapy, to encompass all adult patients with primary advanced or recurrent endometrial cancer (search). This includes patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumors, a population representing 70% to 75% of endometrial cancer cases and facing limited treatment options. The CHMP's opinion is based on data from the Phase III RUBY trial, which demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS). The European Commission is expected to make a final decision on marketing authorization in the first quarter of 2025.
Breakthrough Therapy Designation for Dostarlimab in Rectal Cancer
In the United States, dostarlimab has been granted Breakthrough Therapy Designation (BTD) by the FDA for locally advanced mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) rectal cancer (search). This designation was supported by data showing a 100% complete response rate in all 42 patients who completed dostarlimab treatment. The BTD is reserved for drugs demonstrating potential for significant improvement over existing therapies for serious conditions. Dostarlimab previously received Fast Track designation for the same patient population in January 2023.
PRIME Designation for GSK’227 in Small-Cell Lung Cancer
GSK’s B7-H3 (search)-targeted antibody-drug conjugate (ADC), GSK’227 (search), has received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for relapsed extensive-stage small-cell lung cancer (search) (ES-SCLC). The PRIME designation is based on promising preliminary clinical data. This regulatory milestone follows the FDA's granting of Breakthrough Therapy Designation to GSK’227 in August. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, stated that this PRIME Designation is an important step forward as GSK seeks to accelerate the development of GSK’227 in ES-SCLC and other tumor types with limited treatments.