Pfizer presents positive data from phase 2 study of ponsegromab in patients with cancer cachexia Page 1

Pfizer Inc. (NYSE: PFE) today announced that the Phase 2 study of ponsegromab, a monoclonal antibody directed against growth differentiation factor-15 (GDF-15), met its primary endpoint of change from baseline in body weight compared to placebo in people with cancer cachexia and elevated levels of GDF-15. Cachexia is a common, life-threatening, wasting condition that can significantly impact the quality of life of affected cancer patients.^i,iii The results are presented today as a late-breaking Proffered Paper Presentation (LBA82) at the European Society for Medical Oncology (ESMO) 2024 Congress and are simultaneously published in The New England Journal of Medicine (NEJM).

“Cachexia is a common condition in cancer patients, associated with weight loss, functional decline and ultimately poor outcomes. Despite the number of people who suffer from cachexia, there are no available options for us to help treat patients,” said Jeffrey Crawford, MD, George Barth Geller Professor for Research at Duke Cancer Institute and lead investigator. “This study showed us that those who received ponsegromab had improvements in body weight, muscle mass, quality of life and physical function. These findings offer hope that a breakthrough targeted treatment may be on the horizon for our patients.”

The Phase 2 study included 187 participants with non-small cell lung cancer, pancreatic cancer, or colorectal cancer. Ponsegromab demonstrated significant and robust increases in body weight at 12 weeks across all doses: 2.02% (95% confidence interval (CI), -0.97 to 5.01%) in the 100 mg treatment group, 3.48% (95% CI, 0.54 to 6.42%) in the 200 mg group, and 5.61% (95% CI, 2.56 to 8.67%) in the 400 mg group, compared to placebo. Improvements in multiple domains of the cachexia phenotype were observed in the 400 mg group, including measures of appetite and cachexia symptoms, physical activity, and skeletal muscle index. No clinically significant adverse trends were noted with ponsegromab administration. Treatment-related adverse events occurred in 8.9% of patients receiving placebo and in 7.7% of patients receiving ponsegromab.ⁱ

“Discovered and developed in-house at Pfizer, ponsegromab represents our ability to translate deep scientific expertise into patient benefit,” said Charlotte Allerton, head of Discovery and Early Development, Pfizer. “These results provide strong evidence that we have unlocked a mechanism to interrupt a critical driver of cachexia, GDF-15, which has the potential to impact patients with cancer cachexia and other life-threatening conditions. We look forward to advancing this program as part of our broader cardiometabolic portfolio to address weight management across the spectrum of patient needs.”

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