Swim Across America-Funded Cancer Research Leads to Landmark FDA Approval of Immunotherapy for Rectal Cancer

Groundbreaking research at Swim Across America Lab at Memorial Sloan Kettering Cancer Center helps advance immunotherapy treatment for accelerated FDA approval

CHARLOTTE, NC, UNITED STATES, October 22, 2026 /EINPresswire.com/ -- A groundbreaking immunotherapy treatment for rectal cancer, developed through pioneering research at Memorial Sloan Kettering Cancer Center (MSK) with critical early-stage funding from Swim Across America, has received accelerated approval from the U.S. Food and Drug Administration (FDA). The historic approval of Jemperli (dostarlimab) on Oct. 19, 2026, offers certain patients with locally advanced rectal cancer the possibility of eliminating their cancer without chemotherapy, radiation or surgery.

The approval builds on research led by Luis Diaz Jr., MD, and Andrea Cercek, MD, gastrointestinal oncologists at MSK, whose pioneering clinical trials demonstrated that immunotherapy alone could eliminate tumors in patients with specific genetic characteristics, as reported in the June 2022 and April 2025 issues of The New England Journal of Medicine.

Swim Across America provided critical funding for early research and clinical trials through its longstanding support of immunotherapy research at MSK, including work in the Swim Across America Lab, funded by Swim Across America – Long Island Sound and Swim Across America – Nassau-Suffolk.

The FDA granted accelerated approval to Jemperli, developed by GSK, for adults with stage II or III locally advanced rectal cancer whose tumors are microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR). These genetic characteristics make tumors particularly responsive to immunotherapies that help the immune system recognize and attack cancer cells.

Standard rectal cancer treatment often involves chemotherapy, radiation and major surgery, potentially causing permanent colostomies, infertility, incontinence and other lifelong complications. This immunotherapy offers eligible patients the possibility of avoiding these treatments while preserving their organs and quality of life.

"This is an extraordinary milestone for cancer research – and for the thousands of swimmers, volunteers and donors who have supported critical cancer research through Swim Across America throughout the years," said Rob Butcher, CEO of Swim Across America. "Our mission is to fund innovative cancer research that gives patients hope, and this FDA approval demonstrates how early investments in promising science can lead to treatments that transform lives. We are incredibly proud of the groundbreaking research at Memorial Sloan Kettering and grateful to our Swim Across America communities whose fundraising has helped make this progress possible."

In the initial clinical trial, all 12 rectal cancer patients treated with dostarlimab experienced a complete clinical response, meaning no detectable evidence of cancer following treatment. None required chemotherapy, radiation or surgery during the initial follow-up. The unprecedented 100% clinical response rate attracted worldwide attention and led to expanded studies.

In April 2025, additional findings published in The New England Journal of Medicine and presented at the American Association for Cancer Research Annual Meeting demonstrated immunotherapy's potential for a broader range of cancers. The expanded study included 103 patients with stage I-III cancers: 49 with rectal cancer and 54 with other cancers, including gastroesophageal, hepatobiliary, colon, genitourinary and gynecologic cancers. Approximately 80% avoided surgery following immunotherapy.

"Grants provided by Swim Across America were critical to our initial study and advancing this trial to phase 2," said Dr. Diaz, gastrointestinal oncologist and head of the Division of Solid Tumor Oncology at MSK.

The FDA's October 2026 accelerated approval was supported primarily by results from AZUR-1, an international clinical trial involving 154 patients with previously untreated stage II or III MSI-H/dMMR locally advanced rectal cancer. According to the FDA, 110 patients, or 71%, received dostarlimab alone without additional cancer treatment or disease progression during the study assessment period. The trial also demonstrated sustained complete clinical responses in a substantial proportion of patients.

The approval is the first for an immunotherapy specifically indicated for this patient population. Continued clinical follow-up and confirmatory research will help establish its long-term benefits.

Beyond eliminating detectable cancer, the treatment offers the possibility of preserving bowel, bladder and sexual function, fertility and independence.
"This study shows that immunotherapy can replace surgery, radiation and chemotherapy for mismatch repair-deficient solid tumors, which could help patients preserve their organs and avoid the harsh side effects of chemo and radiation," said Dr. Cercek, gastrointestinal oncologist and co-director of the Center for Young Onset Colorectal and Gastrointestinal Cancer at MSK.

"Preserving a patient's quality of life, while also successfully achieving positive results in eliminating their cancer, is the best possible outcome. They can return to their daily routines and maintain their independence," Dr. Cercek added.

Dr. Cercek also shared the emotional milestone of several patients becoming pregnant and having babies after treatment — something previously considered unlikely following traditional treatments for these cancers.

For decades, Swim Across America has supported innovative immunotherapy research at MSK through grants generated by its charity swims, including Swim Across America – Long Island Sound, Swim Across America – Nassau-Suffolk and Swim Across America – Fairfield County, its three New York City-area open water swims.

The Swim Across America Lab at MSK focuses on advancing immunotherapy research and clinical trials. Swim Across America-supported research has contributed to the development of four previously FDA-approved immunotherapy medicines: ipilimumab (Yervoy), nivolumab (Opdivo), pembrolizumab (Keytruda) and atezolizumab (Tecentriq). Jemperli (dostarlimab) now joins that list as a fifth immunotherapy milestone associated with Swim Across America-supported research.

Since its founding in 1987, Swim Across America has raised more than $150 million to fight cancer. Each year, thousands of swimmers, volunteers, donors and Olympians participate in charity swims in 27 communities nationwide, supporting cancer research, clinical trials and patient programs. The organization funds more than 60 cancer research projects annually and has 10 named Swim Across America Labs at leading research institutions.

Research associated with the dostarlimab clinical trials also received support from the National Institutes of Health, National Cancer Institute, Stand Up To Cancer and other research partners. GSK provided the immunotherapy medicine used in the trials.

About Swim Across America
Swim Across America, Inc. (SAA) raises money and awareness for cancer research, prevention and treatment through swimming-related events. With the help of volunteers and Olympians, Swim Across America is an innovator and leader in giving hope to those fighting cancer. To learn more, visit swimacrossamerica.org, Facebook @SwimAcrossAmerica and Instagram @SAASwim.

Jeni Howard
Swim Across America
+1 203-273-4246
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Dr. Luis Diaz and Dr. Andrea Cercek Speech at Long Island Sound 2025