GSK (GSK.L) said Monday that the phase 2 Azur-1 trial of Jemperli, or dostarlimab, achieved its primary objective, showing the treatment could allow certain rectal cancer patients to avoid or delay surgery, chemotherapy and radiation.
"The AZUR-1 results support the potential for dostarlimab to transform treatment for [stage II/III mismatch repair deficient/microsatellite instability-high] 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," said Hesham Abdullah, senior vice president, global head of oncology, research & development at GSK.
The single-arm study met its main endpoint, demonstrating "meaningful and sustained clinical complete response rate at 12 months." Additionally, the immunotherapy's safety and tolerability matched the manageable profile observed previously across other solid tumors.
The British drugmaker intends to submit the Azur-1 data to international regulatory bodies for review, with comprehensive findings slated for presentation at an upcoming scientific conference. GSK noted that the US Food and Drug Administration granted both breakthrough therapy and fast track designations for this indication.
Annually, rectal cancer accounts for 730,000 new bowel cancer cases globally, according to the company. The dMMR/MSI-H subtype is present in 5% to 10% of these patients.
GSK's London-listed stock was marginally higher during Monday midday trade.
