$GSK · GSK plc
GSK reported interim phase II AZUR-1 results for Jemperli (dostarlimab) monotherapy in MSI-H/dMMR locally advanced rectal cancer. In an exploratory analysis, 76% of evaluable patients (110/144) achieved a complete response, with 68% sustaining clinical complete response for ≥12 months without surgery. No disease recurrences have been reported after median follow-up exceeding two years. The data supported a recent US approval and will be presented at ESMO.
- 76% of evaluable patients (110/144) achieved a complete response to dostarlimab monotherapy in the AZUR-1 trial
- 68% (98/144) achieved sustained clinical complete response for at least 12 months without surgery
- No disease recurrences reported among responders after median follow-up of more than two years
- Serious adverse reactions occurred in 20% of patients; permanent discontinuation rate was 3%
- Data supported recent US approval of Jemperli in this indication; regulatory reviews ongoing via Project Orbis
Extended-hours trading shows GSK up 0.73% to $51.12, suggesting modest positive reception to the AZUR-1 data. The $101.68B market cap limits percentage moves on single-trial readouts.
The 76% complete response rate with no recurrences after 2+ years supports an organ-preservation paradigm that could eliminate chemo, radiation, and surgery for a subset of rectal cancer patients.
Jemperli competes in the PD-1 space against Merck's Keytruda and BMS's Opdivo; organ-preservation data in MSI-H/dMMR rectal cancer could differentiate it in a niche but growing immuno-oncology segment.
Primary endpoint (cCR12 by independent central review) showed only 47% (54/116), with 38 additional patients still under observation — final data could disappoint versus the 76% exploratory headline.