Pfizer's experimental drug for a common, life-threatening condition The drug causes appetite and weight reduction in cancer patients and has shown positive ends in a mid-stage study, the drugmaker said on Saturday.
Patients with the condition, called cancer cachexia, who took Pfizer's drug showed improvements in body weight, muscle mass, quality of life and physical function, in keeping with the drugmaker. The results could pave the way in which for the drug, a monoclonal antibody called ponsegromab, to be approved within the U.S. as the primary treatment specifically for cancer cachexia.
The disease affects about nine million people worldwide and 80 percent of affected cancer patients are expected to die inside a 12 months of diagnosis, in keeping with the corporate.
Patients with cancer cachexia don’t eat enough to satisfy their body's energy needs, leading to significant fat and muscle loss, leaving them weak, drained, and in some cases unable to perform day by day activities. Cancer cachexia is currently defined as a lack of 5% or more body weight within the last six months in cancer patients, together with symptoms comparable to fatigue, in keeping with the National Cancer Institute.
The disease's symptoms could affect the effectiveness of cancer treatments and contribute to lower survival rates, Pfizer said.
“We would see ponsegromab fit into the treatment of cancer patients and really address this unmet need in cachexia, improving their well-being and their ability to care for themselves. And we also hope that they tolerate the treatment better,” said Charlotte Allerton, head of discovery and early development at Pfizer, in an interview with CNBC.
Pfizer has not disclosed the estimated sales potential of the drug, which could potentially be approved for various uses.
The company presented the information on Saturday on the Congress of the European Society of Medical Oncology 2024a cancer research conference in Barcelona, Spain. The results were also published within the New England Journal of Medicine.
The second phase trial involved 187 individuals with non-small cell lung cancer, pancreatic cancer or colon cancer who had high levels of a key think about cachexia called growth differentiation factor 15, or GDF-15. Allerton said it’s a protein that binds to a particular receptor within the brain and affects appetite.
After 12 weeks, patients who took the best dose of ponsegromab – 400 milligrams – experienced a 5.6 percent weight gain in comparison with those that received a placebo. Patients who took a 200-milligram or 100-milligram dose of the drug experienced a weight gain of about 3.5 percent and a pair of percent, respectively, in comparison with the placebo group.
Allerton said a working group of experts defined a weight gain of greater than 5% as a “clinically meaningful difference in cancer patients with cachexia.” She added that the drug's effect on other health indicators, comparable to increased appetite and physical activity, “is what really gives us encouragement.”
Pfizer said it had not observed any significant uncomfortable side effects with the drug. Treatment-related uncomfortable side effects occurred in 8.9 percent of patients who took a placebo and seven.7 percent of patients who received Pfizer's drug, the corporate said.
The company said it’s discussing plans with regulators for the drug's late-stage development and goals to start trials in 2025 that might be used to file a regulatory application. Pfizer can be studying ponsegromab in a Phase 2 trial in patients with heart failure, who can also suffer from cachexia.
Pfizer's drug works by lowering GDF-15 levels, which Pfizer believes can increase appetite and help patients maintain and gain weight.
“Most of us have low levels of GDF-15 in our tissues when we are healthy. But in many of these chronic diseases, in this case cancer, we actually see an upregulation of GDF-15 levels,” Allerton said.
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