Source: Sharecast
Jemperli, the brand name of immunotherapy drug dostarlimab, met its primary objective in an interim analysis of a registrational phase II trial in patients with stage II and III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally-advanced rectal cancer.
A clinically significant rate of participants showed no detectable signs of cancer a year or more after treatment, GSK confirmed.
The data will now be shared with health authorities for regulatory review, including an accelerated review in the US. If approved, dostarlimab would become the first immunotherapy capable of delaying or even eliminating the need for traditional treatments of chemotherapy, radiation and surgery for some patients. It has already received breakthrough therapy and fast track designations from the US Food and Drug Administration.
Hesham Abdullah, GSK’s global head of oncology, research and development, said the results showed dostarlimab had the potential to "transform" treatment for rectal cancer patients. "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."
Around 730,000 people globally are affected by rectal cancer every year, around 5% to 10% of which have the dMMR/MSI-H subtype. GSK said that while effective, current treatments can "profoundly impact" the quality of patients’ lives, including a lifelong use of a colostomy bag and infertility.
Jemperli - a programmed death receptor-1 (PD-1)-blocking antibody - is being developed as a treatment for colorectal, gynaecologic and head and neck cancers. Discovered by AnaptysBio, GSK is responsible for its ongoing research, development, commercialisation and manufacturing. Jemperli is not currently approved anywhere in the world for rectal cancer.
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