# GSK reports positive interim AZUR-1 results for Jemperli in rectal cancer

- Link: https://www.directorstalkinterviews.com/gsk-reports-positive-interim-azur-1-results-for-jemperli-in-rectal-cancer/4121256038
- Published: 2026-07-13T07:19:02+01:00
- Author: Ethan Davis

**[GSK Plc](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l)**(
[LON:GSK](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l))
has announced positive interim results from the registrational phase II AZUR-1 trial
of Jemperli (dostarlimab) in patients with stage II/III mismatch repair deficient/
microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer. The
single arm trial met its primary objective, showing a meaningful and sustained clinical
complete response rate at 12 months (cCR12).

·   Primary objective met in interim analysis, with clinically significant rate 
of participants showing no detectable signs of cancer one year or more after treatment

·   Results support potential for dostarlimab to eliminate the need for chemotherapy,
radiation and surgery in some patients

·   Data to be shared with health authorities for regulatory review, including accelerated
review in the US

These results support the potential for dostarlimab, if approved, to become the 
first immunotherapy capable of eliminating or delaying the need for chemotherapy,
radiation and surgery for some patients in this population.

Rectal cancer, a type of bowel cancer, affects around 730,000 people globally each
year^(1) and approximately 5-10% of all rectal cancers have the dMMR/MSI-H subtype
^(2). Current standard of care typically includes chemotherapy, radiation, and surgery
^(3). While often effective, these treatments can profoundly impact a patient’s 
quality of life, potentially leading to lifelong use of a colostomy bag, significant
physiological dysfunction, and infertility^(4,5,6).

> **Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said:**“
> The AZUR-1 results support the potential for dostarlimab to transform treatment
> for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal
> cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy,
> radiation and surgery. These data demonstrate that some patients may be able to
> avoid those interventions while remaining free of detectable signs of cancer.”

AZUR-1 results represent a substantial improvement compared to the historical standard
of care^(7) and build on earlier research conducted in collaboration with Memorial
Sloan Kettering Cancer Center, which first demonstrated the potential for dostarlimab
to achieve clinical complete responses without other treatments in patients with
dMMR/MSI-H locally advanced rectal cancer.

In interim data, the safety and tolerability profile of dostarlimab was consistent
with its well-characterised and manageable safety profile observed across solid 
tumours.

Dostarlimab has received both Breakthrough Therapy and Fast Track designations from
the US Food and Drug Administration (FDA) in this setting. GSK plans to share interim
AZUR-1 data with global regulatory authorities to support review. Detailed results
will be presented at a future scientific congress.

**References**

1.     International Agency for Research on Cancer (IARC) (2024) Rectum cancer fact
sheet: GLOBOCAN 2022. World Health Organization. Available at: https://gco.iarc.
who.int/media/globocan/factsheets/cancers/9-rectum-fact-sheet.pdf. Date accessed:
June 2026

2.     Cercek A, et al. Mismatch Repair-Deficient Rectal Cancer and Resistance to
Neoadjuvant Chemotherapy. Clin Cancer Res. 2020 Jul 1;26(13):3271-3279. doi: 1158/
1078-0432.CCR-19-3728. Epub 2020 Mar 6. PMID: 32144135; PMCID: PMC7348681.

3.     Fadlallah, H., El Masri, J., Fakhereddine, H. et al. (2024) ‘Colorectal cancer:
Recent advances in management and treatment’, World Journal of Clinical Oncology,
15(9), pp. 1136-1156. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC11438855/

4.    Cercek, A., Lumish, M., Sinopoli, J. et al. (2022) ‘PD‑1 blockade in mismatch
repair-deficient, locally advanced rectal cancer’, New England Journal of Medicine,
386(25), pp. 2363-2376. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2201445

5.     Negro, S. et al. (2025) ‘Quality of life in rectal cancer treatments: a systematic
review’, Cancers, 17(14), 2310. Available at: https://www.mdpi.com/2072-6694/17/
14/2310

6.    Neibart, S.S. et al. (2020) ‘Quality of life after radiotherapy for rectal
cancer’, Current Colorectal Cancer Reports, 16(1), pp. 1-10. Available at: https://
pmc.ncbi.nlm.nih.gov/articles/PMC7336840/

7.     Cercek A, Roxburgh CS, Strombom P, et al. Adoption of Total Neoadjuvant Therapy
for Locally Advanced Rectal Cancer. JAMA Oncol. 2018;4(6):e180071. doi:10.1001/jamaoncol.
2018.0071

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