GSK plc (GSK) Form 6-K — Oct 19, 2026
GSK announced FDA approval of Jemperli (dostarlimab) as the first and only immunotherapy for adults with stage II and III MSI-H/dMMR locally advanced rectal cancer, granted under the accelerated approval pathway ahead of the PDUFA date. The approval is based on the phase II AZUR-1 trial, in which 68% of evaluable patients achieved sustained clinical complete responses at 12 months by investigator assessment, with no disease recurrences reported among responders after a median follow-up of more than two years.
Key figures
- Azur1 trial size
- 154
- Serious adverse reactions
- 20%
- Ccr12 investigator assessed
- 68% (98/144)
- Ccr12 independent central review
- 47% (54/116)
- Msi h dmmr share of rectal cancers
- 5-10%
- No evidence of cancer one year plus
- 76% (110/144)
- Treatment discontinuation due to adverse reactions
- 3%
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