Pfizerof experimental drugs Common, life-threatening conditions The drug, which causes cancer patients to lose appetite and weight, showed positive results in a mid-stage trial, the drugmaker said Saturday.
According to the drug company, patients with cancer cachexia experienced improvements in weight, muscle mass, quality of life and physical function after receiving Pfizer’s treatment. These results could pave the way for the monoclonal antibody drug, ponsegromab, to become the first treatment approved specifically for cancer cachexia in the United States.
The disease affects about 9 million people worldwide, and 80 percent of cancer patients are expected to die within a year of diagnosis, according to the company.
Patients with cancer cachexia are unable to eat enough food to meet their body’s energy needs, resulting in significant loss of fat and muscle, leaving them weak, fatigued, and in some cases unable to perform daily activities. According to the Cancer Society, cancer cachexia is currently defined as a weight loss of 5% or more in a cancer patient over the past six months, along with symptoms such as fatigue. National Cancer Institute.
Pfizer said symptoms of the disease may make cancer treatments less effective and lead to lower survival rates.
“We’re going to see ponsegromab as a treatment for cancer patients that really addresses the unmet needs in cachexia and in that way improves their health and their ability to take care of themselves, and we hope they can tolerate more of it. treatment,” Allerton, head of discovery and early development at Pfizer in Charlotte, told CNBC.
Pfizer has not disclosed estimated revenue opportunities for the drug, which may be approved for different uses.
The company was on Saturday European Society for Medical Oncology 2024 CongressCancer Research Conference in Barcelona, Spain. The findings were also published in the New England Journal of Medicine.
The phase 2 trial followed 187 patients with non-small cell lung cancer, pancreatic cancer or colorectal cancer and high levels of a key driver of cachexia called growth differentiation factor 15, or GDF-15. Allerton said it is a protein that binds to specific receptors in the brain and has an impact on appetite.
After 12 weeks, patients taking the highest dose of ponsegromab (400 mg) gained 5.6% more weight than those taking placebo. Compared with the placebo group, patients taking the 200 mg or 100 mg dose gained about 3.5% and 2%, respectively.
An expert working group defined weight gain of more than 5 percent as “a clinically meaningful difference in cancer patients with cachexia,” Allerton said. She added that the drug’s effects on other health indicators, such as increased appetite and physical activity, “really encouraged us.”
Pfizer said it had not observed any significant side effects from the drug. The company said 8.9% of people who took the placebo experienced treatment-related side effects, while 7.7% of people who took the Pfizer treatment experienced treatment-related side effects.
The company said it is discussing late-stage development plans for the drug with regulators and aims to begin studies for approval in 2025. Pfizer is also studying posegromab in a Phase 2 trial in patients with heart failure who may also suffer from cachexia.
Pfizer’s drug works by lowering levels of GDF-15. Pfizer believes this could improve appetite, allowing patients to maintain and gain weight.
“For most of us, when we are healthy, we have lower levels of GDF-15 in our tissues, but we do see upregulation of GDF-15 in more chronic diseases, in this case, in cancer,” Allerton said.
