Clinical Trial News

Pfizer's Phase 2 study of ponsegromab met its primary endpoint, showing a 5.6% mean increase in body weight at the highest dose compared to placebo in cancer cachexia patients. Ponsegromab was generally safe and well-tolerated, with improvements in appetite, cachexia symptoms, physical activity, and muscle mass. Registration-enabling studies are planned to start in 2025.

IO Biotech announced promising Phase 2 data for IO102-IO103 in combination with KEYTRUDA® in SCCHN patients at ESMO 2024, showing a 44.4% ORR and 6.6-month median PFS, with no new safety concerns.

FDA approves OCREVUS ZUNOVO™, a twice-a-year subcutaneous injection for relapsing and primary progressive multiple sclerosis, offering more treatment options and flexibility.

Daiichi Sankyo reports positive Phase I trial results for DS-9606, an ADC targeting CLDN6 in advanced solid tumours, showing promising safety, tolerability, and clinical activity.

Natera announces 3 peer-reviewed Signatera papers, reaching over 85 publications, including groundbreaking colorectal cancer data from the GALAXY trial and a new study on immune checkpoint inhibitors in triple negative breast cancer.

Eli Lilly's Ebglyss (lebrikizumab-lbkz) receives FDA approval for treating moderate-to-severe atopic dermatitis in individuals aged 12+ weighing at least 40kg, not well controlled by topical therapies. Ebglyss, a targeted IL-13 inhibitor, offers a monthly maintenance injection with initial dosing and potential itch relief, based on ADvocate 1, 2, and ADhere studies. Common side effects include eye and eyelid inflammation, injection site reactions, and shingles. Lilly plans to commercialize Ebglyss in the US and offers support services for patient access.

Daiichi Sankyo reports positive Phase I trial findings for DS-9606, an ADC targeting CLDN6 in advanced solid tumours, showing promising clinical activity and safety.

A decade-long study finds that a combination of nivolumab and ipilimumab significantly extends survival for patients with advanced melanomas, with median survival now over six years. The study, published in the New England Journal of Medicine, shows no increase in adverse effects over 10 years, suggesting these immunotherapy drugs can transform metastatic melanoma into a manageable, long-term condition.

Kisqali (ribociclib) + endocrine therapy (ET) reduces recurrence risk by 28.5% beyond 3 years in HR+/HER2- early breast cancer, with consistent iDFS benefits across subgroups, including node-negative disease. Safety aligns with prior findings, and FDA action is expected in Q3.

NUBEQA® (darolutamide) + ADT showed significant improvement in rPFS vs. placebo + ADT in mHSPC patients, presented at 2024 ESMO Congress.