On July 29, according to the announcement on the CDE official website, GSK'sDostarlimab (Dostarlimab, brand nameJemperli) ObtainClinical trial implied permission, intended forTreatment of adult patients with locally advanced, previously untreated mismatch repair-deficient (dMMR)/high microsatellite instability (MSI-H) rectal cancer.
DostarlimabApproved by the U.S. FDA in April 2021 as a monotherapy for dMMR advanced or recurrent endometrial cancer after prior platinum-based therapy. Later, in July 2023, it was approved for use in combination with carboplatin and paclitaxel, followed byDostarlimabAs a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer determined to be dMMR or MSI-H by an FDA-approved test.
DostarlimabIn August 2021, it received FDA accelerated approval for the treatment of patients with recurrent or advanced solid tumors carrying dMMR, whose dMMR status was confirmed by an FDA-approved test, whose disease continued to progress after receiving prior treatment, and who had no other satisfactory alternative treatment options.
Rectal Cancer Clinical CompleteRemission Rate100%At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, GSK announcedOne itemDostarlimabPhase 2 Study Results in Patients with Locally Advanced Mismatch Repair-Deficient (dMMR) Rectal Cancer（NCT04165772），All 42 patients with locally advanced mismatch repair-deficient (dMMR) rectal cancer who completed PD-1 inhibitor treatment achieved100% clinical complete response rate (cCR), the median follow-up time was 17.9 months. In addition,The first 24 evaluable patients showed sustained clinical complete response during the median follow-up period of 26.3 months.Regarding safety, the most common adverse reactions of all grades were pruritus (13%), rash/dermatitis (21%), diarrhea (9%), nausea (9%), fatigue (11%), fever (6%), and hypothyroidism (11%).In addition, earlySome clinical trial results were announced at the 2022 ASCO Annual Meeting and published in The New England Journal of Medicine.Results of Dostarlimab Published in The New England Journal of MedicineBased on this research evidence:The 100% (n=14) cCR rate reported for the first time in the trial,DostarlimabIt has been included in the National Comprehensive Cancer Network (NCCN) guidelines as a single-agent immunotherapy for dMMR/MSI-H rectal cancer patients.
NCCN Guidelines Recommend Dostarlimab for Neoadjuvant/Targeted Immunotherapy in dMMR/MSI-H Rectal Cancer
To obtain larger sample clinical evidence, a global, single-arm, open-label phase 2 clinical study AZUR-1 (NCT05723562) was initiated concurrently, expecting to enroll 150 previously untreated locally advanced stage II/III dMMR/MSI-H rectal cancer patients for verification.DostarlimabThe efficacy and safety of the single drug, with primary endpoint data expected to be completed around November 2026.Phase 2 Study of Dostarlimab Monotherapy (NCT05723562)At the same time, GSK has also launched a phase 3 clinical trial to compare the use of early dMMR/MSI-high advanced colon cancer patients before surgery.DostarlimabThe efficacy of the therapy compared with standard chemotherapy. The trial will recruit over 700 patients globally.Phase 3 Study of Dostarlimab Monotherapy (NCT05855200）2.https://clinicaltrials.gov/study/NCT05723562?intr=dostarlimab&rank=13.https://clinicaltrials.gov/study/NCT04165772?cond=NCT04165772&rank=14.PD-1 Blockade in Mismatch Repair–Deficient, Locally Advanced Rectal Cancer5.Dostarlimab 2 for 2: Snagging 100% Clinical CR in dMMR Locally Advanced Rectal Cancer.Author(s):Caroline SeymourScan the WeChat QR code, add the editor of the Biologics Circle, and those who meet the requirements can join.Biological Products WeChat Group!
Please indicate: Name + Research Direction!All articles reprinted by this official account are intended to convey more information, with the source and author clearly indicated. Media or individuals who do not wish to be reprinted can contact us (cbplib@163.com), and we will immediately delete the content. All articles represent the views of the author and do not represent the position of this website.
