GSK plc (NYSE:GSK) on Monday reported interim results from its registrational Phase 2 AZUR-1 trial of Jemperli (dostarlimab) in rectal cancer patients.
The data showed that its immunotherapy Jemperli achieved a meaningful and sustained clinical complete response at 12 months in patients with stage II/III mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer.
The company said the findings could position the drug, if approved, as the first immunotherapy capable of eliminating or delaying the need for chemotherapy, radiation, and surgery for some patients.
AZUR-1 Trial Meets Primary Objective
The single-arm AZUR-1 study met its primary endpoint by demonstrating a sustained clinical complete response at 12 months.
The trial enrolled 154 patients, each receiving nine cycles of dostarlimab over six months.
According to GSK, the interim findings compare favorably with the historical standard of care and build on earlier research conducted with Memorial Sloan Kettering Cancer Center that first suggested dostarlimab could produce complete clinical responses without chemotherapy, radiation, or surgery in this patient population.
About 5% to 10% of rectal cancer cases are classified as dMMR/MSI-H. Patients with this subtype are typically treated with chemotherapy, radiation, and surgery.
GSK Highlights Potential To Reduce Treatment Burden
Hesham Abdullah, SVP and global head of oncology R&D at GSK, said the AZUR-1 data underscore dostarlimab’s potential to change treatment for patients with dMMR/MSI-H locally advanced rectal cancer.
He said many patients currently face the long-term burden associated with chemotherapy, radiation, and surgery, while the latest results indicate that some patients may be able to avoid those interventions and remain free of detectable signs of cancer.
Safety Profile And Next Regulatory Steps
GSK said the interim analysis showed a safety and tolerability profile consistent with the well-characterized experience previously observed with dostarlimab across solid tumors.
The U.S. Food and Drug Administration has already granted dostarlimab Breakthrough Therapy and Fast Track designations for this indication.
GSK said it plans to submit the interim AZUR-1 data to global regulatory authorities to support review, with detailed study findings scheduled to be presented at a future scientific congress.
Jemperli is currently approved for endometrial cancer and is not currently approved anywhere in the world for rectal cancer.
GSK Stock Performance And Technical Analysis
GSK stock was down nearly 2% in Monday’s premarket session as broader market weakness weighed on sentiment. Nasdaq futures fell 1.06%, while S&P 500 futures slipped 0.38%.
Despite the premarket pullback, GSK remains in a longer-term uptrend.
The stock is trading about 2.1% above its 200-day simple moving average and 1.1% above its 50-day simple moving average. However, it is about 0.6% below its 20-day simple moving average, suggesting a short-term pause.
The relative strength index stands at 53.02, indicating neutral momentum. That suggests buying and selling pressure remain balanced.
The moving-average setup also remains positive. The 20-day average is above the 50-day average, while the 50-day average remains above the 200-day average. Even so, the stock is about 3.4% below its 100-day simple moving average, which could limit near-term gains.
Technical resistance is near $53.50, while support sits around the $50 level.
GSK Stock Price Activity: GSK shares were down 1.50% at $51.99 during premarket trading on Monday, according to Benzinga Pro data.
Photo by HJBC via Shutterstock
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