Pfizer Presents Positive Data From Phase 2 Study Of Ponsegromab In Patients With Cancer Cachexia By Investing.com

• The study met the primary endpoint of change from baseline in body weight for ponsegromab compared to placebo at all ponsegromab doses tested, reaching a 5.6% mean increase at the highest dose tested at 12 weeks; Ponsegromab was generally considered safe and well tolerated at all dose levels
• At the highest dose tested, improvements were observed from baseline in diet and cachexia symptoms, physical activity, and body weight.
• Based on the positive results of Phase 2, courses that allow enrollment will begin in 2025

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

Cachexia is a common condition in cancer patients, associated with weight loss, decreased performance, and ultimately poor outcomes. Despite the number of people suffering from cachexia, there are no options available to help treat patients, said Jeffrey Crawford, MD, George Barth Geller Professor for Research at Duke Cancer Institute, and principal investigator. This study showed that those who received ponsegromab had improvements in body weight, muscle mass, quality of life, and physical activity. These findings give hope that the success of targeted therapy may be closer to our patients.

The Phase 2 study involved 187 participants with non-small cell lung cancer, pancreatic cancer, or colorectal cancer. Ponsegromab showed a significant and sustained increase in body weight after 12 weeks at 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 with placebo. Improvements in all domains of the cachexia phenotype were observed in the 400 mg group including measures of appetite and symptoms of cachexia, physical activity and skeletal muscle index. No adverse clinical trends were noted with ponsegromab administration. Treatment-related adverse events occurred in 8.9% of patients taking placebo and 7.7% of patients taking ponsegromab.i

Found and developed in-house at Pfizer ponsegromab represents our ability to translate deep scientific expertise into patient benefit, said Charlotte Allerton, Head of Discovery (NASDAQ:) and Early Development, Pfizer. These results provide strong evidence that we have opened a way to interfere with a key driver of cachexia, GDF-15, which has the potential to impact patients with cancer cachexia and other life-threatening conditions. We look forward to developing this program as part of our comprehensive cardiometabolic portfolio to address weight management for all patient needs.

Based on these positive results, Pfizer is discussing late-stage development plans with regulators with the goal of starting studies that allow enrollment in 2025. Ponsegromab is also being investigated in a Phase 2 study in patients with heart failure (HF) and elevated serum GDF. -15 concentration (NCT05492500).

About a Phase 2 Trial in Cancer Cachexia
The main objective of the Phase 2 study (NCT05546476) is to evaluate the effect of ponsegromab on body weight in patients with cancer (non-small cell lung cancer, pancreatic cancer or colorectal cancer), cachexia and elevated serum GDF-15 concentrations (>1500 pg/mL). Secondary endpoints and evaluations included measures such as: Change from baseline in eating and cachexia symptoms, digital measures of physical activity, and changes in lumbar skeletal muscle index (LSMI). Patients (n=187) received ponsegromab (100 mg, 200 mg or 400 mg) or placebo once every four weeks subcutaneously for 12 weeks.

About Cachexia
Cachexia is a complex, disabling, and life-threatening condition that is estimated to affect 9 million people worldwide.ii Symptoms such as weight loss and muscle wasting can reduce patients' ability to tolerate treatment for their chronic diseases, such as cancer and heart failure, and can significantly impact quality of life. .ii,iii In cancer, cachexia can reduce the effectiveness of cancer treatments and is thought to contribute to decreased survival rates and may account for up to 30% of cancer-related deaths.iv Despite its severity, there are no FDA-approved treatments for cachexia. iii

About Ponsegromab
Ponsegromab is an investigational monoclonal antibody designed to treat cachexia by targeting GDF-15. Early Phase 1b data in participants with cancer cachexia showed evidence of ponsegromab's mechanism by robust suppression of circulating unbound GDF15 levels. Results showed encouraging signs of efficacy including increased body weight and improved motivation in patient-reported outcomes.

About Pfizer: Success That Changes Patients' Lives
At Pfizer, we use our world-class science and resources to bring treatments to people that dramatically extend and improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and production of healthcare products, including new medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to improve wellness, prevention, treatment and cures that challenge the most feared diseases of our time. In line with our responsibility as one of the world's most innovative biopharmaceutical companies, we partner with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare worldwide. For 175 years, we have worked to make a difference for all who depend on us. We often post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us at www.Pfizer.com and follow us on X at @Pfizer again @Pfizer NewsLinkedIn, YouTube and like us on Facebook (NASDAQ:) at Facebook.com/Pfizer.

Disclosure Notice
The information contained in this release is as of September 14, 2024. Pfizer undertakes no obligation to update any forward-looking statements contained in this release as a result of new information or future events or developments.
This release contains forward-looking information about ponsegromab, an investigational monoclonal antibody designed to treat cachexia, including its potential benefits and late-stage development plans, and Pfizer's cardiometabolic portfolio, which involves significant risks and uncertainties that could cause actual results to differ. materially. those expressed or implied by those statements. Risks and uncertainties include, among other things, uncertainties inherent in research and development, including the ability to meet expected clinical outcomes, the start and/or completion dates of our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, and the possibility of new negative clinical data and additional analysis of existing clinical data, including results from a Phase 2 study of ponsegromab in patients with heart failure; the risk that clinical trial data are subject to different interpretations and evaluations by regulatory authorities; whether regulatory authorities will be satisfied with the design and results from our clinical studies; when and in which areas drug applications may be filed for any potential indication for ponsegromab or any other cardiometabolic product candidates; that any such applications for ponsegromab or any other such product candidates may be approved by regulatory authorities, which will depend on a number of factors, including determining whether the benefits of the product outweigh the known risks and determining the efficacy of the product and, if approved, whether ponsegromab or what other such product will be commercially successful; decisions by regulatory authorities affecting labeling, manufacturing processes, safety and/or other matters that may affect the availability or commercial viability of ponsegromab or any other product candidates; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and its subsequent reports on Form 10-Q, including in its sections and captions Risk Factors and Forward. Prospective Information and Factors That May Affect Future Results, and its subsequent reports on Form 8-K, are all filed with the U.S. Securities and Exchange Commission and are available at www.sec.gov and www.pfizer.com .

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I Groarke J, et al. Ponsegromab for the treatment of Cancer Cachexia. New England Journal of Medicine. Accessed September 14, 2024.
ii Cleveland Clinic. Cachexia (Wasting Syndrome). Cachexia (Wasting Syndrome): Symptoms and Treatment (clevelandclinic.org). Accessed September 3, 2024.
iii Lisa Martin, Michael B. Sawyer, Cancer Cachexia: Emerging Preclinical Evidence and the Pathway Forward to Clinical Trials, JNCI: Journal of the National Cancer InstituteVolume 107, Issue 12, December 2015, https://doi.org/10.1093/jnci/djv322
iv National Cancer Institute. Cancer Cachexia: After Years of No Progress, Progress Looks Possible. Treating Cancer Cachexia: Progress Looks Possible – NCI. Accessed September 3, 2024.

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