BARCELONA — At a major cancer conference, Pfizer made an unexpected announcement: It has late-stage plans in weight management. But it’s not targeting weight loss like one would first think amid the drug industry’s current fixation on obesity.
While industry insiders and investors have eagerly awaited updates on Pfizer’s obesity programs, the New York pharma giant is now advancing a drug on the other end of the weight management spectrum.
The drugmaker said Saturday it plans to take a GDF15-directed monoclonal antibody, named ponsegromab, into registration-enabling testing next year for cancer patients with cachexia, a condition that can lead to muscle wasting and life-threatening weight loss in patients with cancer.
The decision to move into a registration-enabling study — plans of which are still pending discussions with regulators, according to a Pfizer spokesperson — is based on Phase 2 data presented in a late-breaking paper this weekend at the annual European Society for Medical Oncology confab in Barcelona.
Ponsegromab was tested in a Phase 2 of 187 patients with non-small cell lung cancer, pancreatic cancer and colorectal cancer, and trial investigators looked at change from baseline in body weight as the primary endpoint. After 12 weeks, Pfizer said the experimental drug met the primary endpoint as there were “significant and robust increases” in patients’ body weight across all doses (100 mg, 200 mg and 400 mg) compared to placebo.
At the highest dose, patients reached a 5.6% mean increase in body weight, according to Pfizer. The company said there were “no clinically significant adverse trends noted with ponsegromab administration.” Treatment-related adverse events happened in 8.9% of patients on placebo and 7.7% of patients on Pfizer’s drug. The highest dose also showed improvements on measures of appetite, physical activity and muscle mass, Pfizer said.
Charlotte Allerton“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,” Charlotte Allerton, head of discovery and early development at Pfizer, said in a statement.
She highlighted that ponsegromab was discovered internally. “We look forward to advancing this program as part of our broader cardiometabolic portfolio to address weight management across the spectrum of patient needs.”
There’s no FDA-approved treatment for cancer cachexia. In Japan, ONO Pharmaceutical markets Adlumiz. Also known as anamorelin, the tablet received a 2020 greenlight in that country after being rejected in Europe three years prior. It’s a ghrelin receptor agonist, which works by drumming up pathways involved in appetite and metabolism.
The Cleveland Clinic estimates about 9 million people worldwide are affected by the condition. In addition to cancer, cachexia can also be a complication of Alzheimer’s, dementia, obstructive pulmonary disease and heart failure. Pfizer is also testing ponsegromab in a separate Phase 2 in patients with heart failure who have elevated serum concentrations of GDF-15.
Other biotechs are also looking at GDF-15. German startup CatalYm raised $150 million this summer to test its GDF15-neutralizing antibody for solid tumors, and formerly public NGM Bio raised $122 million in July to test a GDF15/GFRAL antagonist for a rare condition known as hyperemesis gravidarum. Novartis shelved its GDF-15 agonist last year.