Jemperli (dostarlimab-gxly) approved in US as first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer
The FDA approved GSK's Jemperli (dostarlimab-gxly) as the first and only immunotherapy for adults with stage II/III MSI-H/dMMR locally advanced rectal cancer under the accelerated approval pathway. The approval is based on the phase II AZUR-1 trial, where 68% of evaluable patients achieved a sustained clinical complete response at 12 months by investigator assessment, with no disease recurrences reported among responders after a median follow-up of more than two years. Jemperli monotherapy could allow eligible patients to avoid chemotherapy, radiation and surgery, though the indication is limited to the 5-10% of rectal cancers that are MSI-H/dMMR.
Key figures
- Drug Name
- Jemperli (dostarlimab-gxly)
- Phase Of Trial
- Phase II
- Trial name
- AZUR-1
- Approval pathway
- accelerated approval
- Median follow up
- more than two years
- Biomarker prevalence
- 5-10% of rectal cancers
- Discontinuation rate
- 3%
- C CR12 independent review
- 47% (54/116)
- Serious adverse reactions
- 20%
- C CR12 investigator assessed
- 68% (98/144)
- No evidence of cancer 1yr plus
- 76% (110/144)
AI analysis
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