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Patients with residual disease would proceed to chemoradiation until cCR was observed. If patients achieved cCR they entered a nonoperative follow-up window and underwent evaluation every 4 months. Further, each target lymph node must have decreased short axis to less than 0.5 cm diameter. Specifically, there must be visual evidence of primary rectal tumor disappearance on a normal digital exam and lack of signal on diffusion-weighted imaging with scar on T2-weighted imaging. Upon treatment completion at 6 months patients then underwent comprehensive radiologic and endoscopic evaluation including tumor biopsy collection and T2-weighted and diffusion-weighted MRI of the rectum, 18F-fluorodeoxyglucose positron emission tomography, and CT scan of the chest, abdomen, and pelvis.Ī cCR was defined as no evidence of residual tumor on both the digital and endoscopic rectal exams and on the rectal MRI results. At these key timepoints patients underwent endoscopic and digital rectal exams. At baseline and through treatment, patients were closely monitored and assessed for response at 6 weeks, 3 months, and 6 months.

PRESENTATION EXPERT AT TARGET TRIAL

Patients enrolled on the trial received the PD-1 monoclonal antibody dostarlimab at 500 mg intravenously every 3 weeks for 6 months, equaling 9 total cycles. Investigators hypothesized that PD-1 blockade may replace chemotherapy, chemotherapy and radiation, or replace the trimodality approach of chemotherapy, radiation, and surgery. “However, because components of the standard of care may lead to significant morbidity and quality-of-life issues, many recent studies have tried to eliminate components of the standard of care while still maintaining efficacy,” said Ng, who is also an associate professor of medicine at Harvard Medical School.Īpproximately 5% to 10% of rectal cancers are dMMR, which confers resistance to chemotherapy. “Standard of care for T3, T4, or node-positive rectal cancer involves trimodality therapy,” explained Kimmie Ng, MD, MPH, associate chief of the Division of Gastrointestinal Oncology, director of the Young-Onset Colorectal Cancer Center, codirector of the Colon and Rectal Cancer Center, and director of Translational Research in the Division of Gastrointestinal Oncology at Dana-Farber Cancer Center in Boston, Massachusetts in a discussion of the data. quite a bit of a range from 0.7 to nearly 24 months and all patients remain disease free,” Cercek said. “The majority of our patients at 6 months, but we did have a few at 3 months as well. The median follow-up for the analysis was 6.8 months (range, 0.7-23.8). It highlights the clinical impact of biomarker-driven therapy, in other words of moving precision medicine into early-stage disease.” Cercek is section head of colorectal cancer and codirector of the Center for Young Onset Colorectal and Gastrointestinal Cancers at Memorial Sloan Kettering Cancer Center in New York, New York, where the trial was conducted. In conclusion we believe these data provide the framework for immunoablative therapies. “Longer follow-up is certainly required to establish the durability of this treatment. “No patients have required chemotherapy, radiation, or surgery there has been no disease recurrence observed during the follow-up period,” Andrea Cercek, MD, said in a presentation of the data. Single-agent dostarlimab-gxly (Jemperli) elicited a clinical complete response (cCR) rate of 100% with no evidence of residual tumor among 14 patients with stage II/III mismatch repair–deficient (dMMR) locally advanced rectal cancer, according to data from a phase 2 trial (NCT04165772) presented at the 2022 ASCO Annual Meeting and simultaneously published in the New England Journal of Medicine.

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