Cancer Immunotherapy Funded by Swim Across America Gains FDA Approval
An immunotherapy treatment for rectal cancer whose early-stage research was funded by Swim Across America has received accelerated approval from the FDA.
The drug – Jemperli (dostarlimab) – for rectal cancer was developed in a research program at Memorial Sloan Kettering Cancer Center. It received accelerated approval by the United States Food and Drug Administration on Oct. 19, allowing use in patients with advanced rectal cancer in lieu of chemotherapy, radiation or surgery.
The research was performed by gastrointestinal oncologists Luis Diaz Jr. and Andrea Cercek at MSK and is targeted at tumor elimination in patients with a specific genetic mutation. Swim Across America, through its Long Island Sound and Nassau-Suffolk events, provided a grant to MSK for early research and clinical trials. It is being developed and manufactured by GSK.
“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,” Swim Across America CEO Rob Butcher said in an organization press release. “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.”
Jemperli showed a 100 percent elimination of tumors from 12 rectal cancer patients in an initial clinical trial. It was again successful in an expanded study of 103 patients with Stage I-III cancers (49 with rectal cancer, 54 with other cancers), and a larger international clinical trial of 154 patients.
“Grants provided by Swim Across America were critical to our initial study and advancing this trial to phase 2,” Dr. Diaz, the head of the Division of Solid Tumor Oncology at Memorial Sloan Kettering Cancer Center, said in a statement about the earlier clinical trial.
SAA has long funded such research via its charity events, including a number clustered in the New York Area. The Swim Across America Lab at MSK focuses on such trials, one of 10 such labs that SAA funds and 60 active research projects it has contributed to. Jemperli is the fifth such medication approved via that lab and Swim Across America funding, joining (brand names in parentheses) ipilimumab (Yervoy), nivolumab (Opdivo), pembrolizumab (Keytruda) and atezolizumab (Tecentriq).
SAA was founded in 1987. It has raised more than $150 million for the fight against cancer, with thousands of swimmers, volunteers and donors each year participating in swims across 27 communities in the United States.
