GSK's cancer drug Jemperli met its primary goal in a mid-stage trial for a specific subtype of rectal cancer affecting 5-10% of patients. The trial showed a clinically significant rate of patients with no detectable cancer for over a year, offering a potential alternative to standard care involving chemotherapy and surgery. The drug, which generated $1.1B in 2025, is already approved for endometrial cancer.
AZUR-1 trial results
- ▪GSK's cancer drug Jemperli met the primary goal of its mid-stage AZUR-1 trial for a specific type of locally advanced rectal cancer
- ▪Interim data from the phase II AZUR-1 trial showed Jemperli's safety and tolerability profile was consistent with previous studies in solid tumours
- ▪The AZUR-1 trial showed a clinically significant rate of patients with no detectable signs of cancer for one year or more after treatment
Rectal cancer subtype characteristics
- ▪The targeted tumors accumulate mutations due to their inability to properly repair DNA damage, making them highly responsive to immunotherapies
- ▪Jemperli is being tested in a rectal cancer subtype that cannot properly repair DNA damage, affecting 5%-10% of 730,000 annual global cases
Treatment advantages over standard care
- ▪The current standard of care for this type of rectal cancer typically includes chemotherapy, radiation, and surgery
- ▪Standard care for this rectal cancer can lead to lifelong side effects such as colostomy bag use and infertility
Jemperli commercial performance
- ▪GSK expects Jemperli to contribute to its long-term sales target of over £40 billion ($53.52 billion) by 2031
- ▪Jemperli, marketed as dostarlimab, generated sales of $1.1 billion in 2025
FDA regulatory designations
- ▪Jemperli has received both Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration
- ▪Jemperli is already approved in the U.S. and UK for specific subtypes of endometrial cancer
- ▪GSK plans to share data from the AZUR-1 trial with global regulators for review
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