Study Results of Dostarlimab-gxly for Locally Advanced Rectal Cancer

Typically, the standard treatment for locally advanced rectal cancer has been neoadjuvant chemotherapy and radiation with surgical resection. However there is a subset of rectal cancer which is caused by a deficiency in mismatch repair or dMMR. This deficiency means that there is an abnormality that affects how DNA gets repaired. An ongoing clinical trial (ClinicalTrials.gov Identifier: NCT04165772) is investigating whether the administration of the drug Dostarlimab-gxly, followed by chemotherapy, radiation treatment and surgery, is effective in the treatment of this type of rectal cancer.

Dostarlimab-gxly (brand name Jemperli, GlaxoSmithKline), a monoclonal antibody PD-1 inhibitor, is the seventh therapy of its kind in the market. It has been approved for the treatment of mismatch repair deficient (dMMR) for solid tumors since August 17, 2021.

Now Clinical trial data published in the New England Medical Journal on June 23, 2022, reveal that locally advanced rectal cancer stage II or III with dMMR is sensitive to drug Dostarlimab-gxly. In the study, a total of 12 patients completed the treatment and followed up for at least six months. The patients were given Dostarlimab-gxly every three weeks for six months. All patients had a clinical complete response without any chemotherapy, radiation treatments or surgery. In addition, the patients had no adverse events of grade 3 or higher reported. Further follow up is needed to determine the duration of the response.

As a reference point, the annual cost of Dostarlimab-gxly for treatment of solid tumors ranges from $150,000-$300,000. 

 

Article written by Stacy Schumacher, RN, BSN, Managed Care Specialist for Summit Reinsurance Services, Inc. For more information about how this may affect your plan, please contact your Summit ReSources care specialist. The following sources were used as reference material for this article:

AMS PredictRx. Accessed 26 July 2022

“Study of Induction PD-1 Blockade in Subjects with Locally Advanced Mismatch Repair Deficient Solid Tumors - Full Text View.” Full Text View - ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT04165772.

Cercek, Andrea, et al. “PD-1 Blockade in Mismatch Repair–Deficient, Locally Advanced Rectal Cancer: Nejm.” New England Journal of Medicine, 23 June 2022, https://www.nejm.org/doi/full/10.1056/NEJMoa2201445.

Jensen, Kristin. “GSK, in Race to Catch up with Rivals, Wins Expanded Approval for Cancer Drug.” BioPharma Dive, 18 Aug. 2021, https://www.biopharmadive.com/news/gsk-jemperli-approval-solid-tumors-dmmr/605205/.