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GSK's Jemperli Delivers Promising Interim Data in Rectal Cancer
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Key Takeaways
GSK said Jemperli met the primary endpoint in the phase II AZUR-1 rectal cancer study.
Jemperli showed a durable 12-month clinical complete response with a consistent safety profile.
GSK plans to share interim AZUR-1 data with global regulatory authorities to support regulatory review.
GSK plc (GSK - Free Report) has announced positive interim data from a mid-stage study evaluating its oncology drug, Jemperli (dostarlimab), in rectal cancer. The registrational phase II AZUR-1 study evaluated Jemperli for the treatment of patients with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer.
Jemperli is currently approved for the treatment of certain endometrial cancers and certain mismatch repair-deficient (dMMR) solid tumors.
Year to date, GSK’s shares have risen 6.7% compared with the industry’s 3.3% growth.
Image Source: Zacks Investment Research
Key Highlights of GSK’s AZUR-1 Study in Rectal Cancer
The AZUR-1 study met its primary endpoint by demonstrating that Jemperli monotherapy achieved a meaningful and durable 12-month clinical complete response in patients with stage II/III dMMR/MSI-H locally advanced rectal cancer. The treatment also exhibited a safety profile consistent with its established and manageable profile across solid tumors.
The therapy received both Breakthrough Therapy and Fast Track designations from the FDA for this indication. GSK plans to submit the interim data to global regulatory authorities to support potential approvals, with detailed study data expected to be presented in the future.
Locally advanced dMMR/MSI-H rectal cancer is a subtype of rectal cancer affecting approximately 5-10% of patients, for whom the current standard of care includes chemotherapy, radiation and surgery, treatments that are often associated with significant long-term quality-of-life challenges.
If approved for this indication, Jemperli could become the first immunotherapy capable of eliminating or delaying the need for chemotherapy, radiation and surgery in selected patients with locally advanced dMMR/MSI-H rectal cancer, potentially transforming the current treatment paradigm.
Jemperli a Key Oncology Drug for GSK
Jemperli (dostarlimab) is GSK's PD-1 inhibitor and a key component of its immuno-oncology portfolio. The drug was developed by GSK in collaboration with AnaptysBio (ANAB - Free Report) .
GSK and ANAB have an agreement to develop therapies targeting immuno-oncology indications.
Per the agreement, GSK is responsible for the development and commercialization of Jemperli, while AnaptysBio is entitled to receive milestone payments and tiered royalties on annual net sales of the drug.
Jemperli continues to deliver strong commercial momentum. In the first quarter of 2026, the drug recorded 40% sales growth at constant currency exchange rates, supported by increased patient uptake across the United States and Europe following approvals in a broader endometrial cancer population.
Beyond its currently approved indications, some label expansion studies are ongoing on Jemperli, either as monotherapy or in combination with other oncology compounds across multiple cancers, including gynecologic, colorectal and head and neck cancers. Approval of expanded indications can potentially boost drug sales in future quarters.
Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $9.15 to $9.47. Over the same period, EPS estimates for 2027 have increased from $10.23 to $10.79. NBIX shares have gained 22.8% year to date.
Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.10. Over the same period, EPS estimates for 2027 have risen to $4.92 from $4.14. LQDA shares have gained 106.5% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
View the Zacks #1 Rank List
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GSK's Jemperli Delivers Promising Interim Data in Rectal Cancer
Key Takeaways
GSK plc (GSK - Free Report) has announced positive interim data from a mid-stage study evaluating its oncology drug, Jemperli (dostarlimab), in rectal cancer. The registrational phase II AZUR-1 study evaluated Jemperli for the treatment of patients with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer.
Jemperli is currently approved for the treatment of certain endometrial cancers and certain mismatch repair-deficient (dMMR) solid tumors.
Year to date, GSK’s shares have risen 6.7% compared with the industry’s 3.3% growth.
Image Source: Zacks Investment Research
Key Highlights of GSK’s AZUR-1 Study in Rectal Cancer
The AZUR-1 study met its primary endpoint by demonstrating that Jemperli monotherapy achieved a meaningful and durable 12-month clinical complete response in patients with stage II/III dMMR/MSI-H locally advanced rectal cancer. The treatment also exhibited a safety profile consistent with its established and manageable profile across solid tumors.
The therapy received both Breakthrough Therapy and Fast Track designations from the FDA for this indication. GSK plans to submit the interim data to global regulatory authorities to support potential approvals, with detailed study data expected to be presented in the future.
Locally advanced dMMR/MSI-H rectal cancer is a subtype of rectal cancer affecting approximately 5-10% of patients, for whom the current standard of care includes chemotherapy, radiation and surgery, treatments that are often associated with significant long-term quality-of-life challenges.
If approved for this indication, Jemperli could become the first immunotherapy capable of eliminating or delaying the need for chemotherapy, radiation and surgery in selected patients with locally advanced dMMR/MSI-H rectal cancer, potentially transforming the current treatment paradigm.
Jemperli a Key Oncology Drug for GSK
Jemperli (dostarlimab) is GSK's PD-1 inhibitor and a key component of its immuno-oncology portfolio. The drug was developed by GSK in collaboration with AnaptysBio (ANAB - Free Report) .
GSK and ANAB have an agreement to develop therapies targeting immuno-oncology indications.
Per the agreement, GSK is responsible for the development and commercialization of Jemperli, while AnaptysBio is entitled to receive milestone payments and tiered royalties on annual net sales of the drug.
Jemperli continues to deliver strong commercial momentum. In the first quarter of 2026, the drug recorded 40% sales growth at constant currency exchange rates, supported by increased patient uptake across the United States and Europe following approvals in a broader endometrial cancer population.
Beyond its currently approved indications, some label expansion studies are ongoing on Jemperli, either as monotherapy or in combination with other oncology compounds across multiple cancers, including gynecologic, colorectal and head and neck cancers. Approval of expanded indications can potentially boost drug sales in future quarters.
GSK’s Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Neurocrine Biosciences (NBIX - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $9.15 to $9.47. Over the same period, EPS estimates for 2027 have increased from $10.23 to $10.79. NBIX shares have gained 22.8% year to date.
Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.10. Over the same period, EPS estimates for 2027 have risen to $4.92 from $4.14. LQDA shares have gained 106.5% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.