GSK (GSK plc, LSE/NYSE: GSK) today announced exciting long-term results from a Phase II supportive collaboration study conducted in partnership with Memorial Sloan Kettering Cancer Center (MSKCC).

The study shows that its development ofJemperli（dostarlimab-gxly) AsErrorPeixiuReDefect (dMMR) LocalizedAdvanced Rectal CancerFirst-line treatment drugs, which can be used asAlternatives to Surgery, reaching an unprecedented100% clinical complete response rate (cCR)。

This important discovery was announced with detailed data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

The AZUR-1 trial, disclosed this time, is a global, multicenter, open-label Phase 2 registrational clinical trial designed to investigate the efficacy and safety of Jemperli monotherapy as an alternative to chemotherapy, radiotherapy, and/or surgery for patients with treatment-naïve dMMR/MSI-H locally advanced rectal cancer.

In this trial, a total of 42 participants receiveddostarlimab-gxlyThe treated patients achieved complete pathological response or no evidence of tumor, a result confirmed through rigorous evaluation procedures such as magnetic resonance imaging, endoscopy, and digital rectal examination. Additionally, among the first 24 patients,Clinical complete response persists, with a median follow-up time of up to 26.3 months.

GSK Senior Leader Hesham Abdullah stated: "This data is very encouraging, with 42 patients showing no evidence of disease, which isdostarlimab-gxlyAn important step in recognizing the potential for treating dMMR locally advanced rectal cancer patients. We look forward to the ongoingAZUR-1AndAZUR-2Further evaluation of its efficacy in certain colorectal cancers in registration studies."

The lead researcher of this Phase II study noted, "These findings demonstrate the potential of dostarlimab-gxly as a new treatment approach for locally advanced dMMR rectal cancer, which may lead to durable complete tumor regression."No need for life-changing treatment”。

Dostarlimab-gxlyGood safety and tolerabilityNo adverse events of grade 3 or higher were reported in the trial.

Jemperli is a drug thatBinding to the PD-1 receptor, andAntibodies that block its interaction with ligands PD-L1 and PD-L2。Jemperli was approved by the U.S. FDA in April 2021 as a monotherapy for dMMR advanced or recurrent endometrial cancer after prior treatment with platinum-containing therapy.

GSK is actively advancing dostarlimab-gxly through its AZUR clinical trial program.dMMR/MSI-H Advanced Colorectal Cancer/Patients in TransitionThe results of the AZUR-1 and AZUR-2 trials will have a profound impact on the future development of Jemperli in the field of colorectal cancer treatment.

Rectal cancer, as the third most common cancer in the world, imposes a tremendous burden on patients globally each year. This research breakthrough undoubtedly offers new hope to those suffering from rectal cancer. With further advancements in subsequent studies, it is anticipated that Jemperli will play an even greater role in the treatment of colorectal cancer.

References:

https://meetings.asco.org/abstracts-presentations/234205

Discovery"Share"And"Thumbs Up"Have you? Click me to take a look.