01/14/2025  |  Emily Bader  |  Oncology News Central

https://www.oncologynewscentral.com/oncology/cancer-trial-failures-study-retractions-highlight-oncology-research-challenges 

Recent headlines involving cancer study retractions, clinical trial failures, and shifting regulatory decisions underscore ongoing oncology research challenges.

Top Journal Retracts Cancer Study After Investigation
Nature has retracted a widely cited melanoma study after investigators found data errors that rendered some results statistically insignificant, affecting “the conclusion about therapy resistance,” according to the retraction notice. Investigators also found inconsistencies in images, source data, sample numbers, and figure labeling, although no scientific misconduct was involved.

Of the 46 authors, four agreed with the retraction, 28 disagreed, and 14 did not respond. Lead author Ashani T. Weeraratna, PhD, from Johns Hopkins University in Baltimore, said that a 2023 replication using updated methods confirmed the original findings, but Nature did not consider these results in the retraction.

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Phase 3 Cancer Trial Halted as Monoclonal Antibody Combo Fails to Improve Survival
Arcus Biosciences has halted a phase 3 study testing its experimental antibodies domvanalimab and zimberelimab with chemotherapy for patients with advanced stomach and esophageal cancers. Interim data showed no survival advantage when compared with the standard treatment of nivolumab (Opdivo) plus chemotherapy, prompting an independent monitoring committee to recommend ending the trial. Other studies of domvanalimab in different cancers will continue, the manufacturer said.

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Controversial Cancer Study Retracted, Reigniting Debate About Herbicide’s Health Risk
A review article concluding that glyphosate, the active ingredient in the weedkiller Roundup, “does not pose a health risk” has been retracted eight years after documents showed that Monsanto employees wrote the article but were not listed as coauthors. The article appeared in Regulatory Toxicology and Pharmacology and has been cited more than 600 times. Editors said that undisclosed corporate authorship and reliance on unpublished Monsanto studies undermined the article’s integrity. Bayer, which now owns Monsanto, maintains that glyphosate is safe when used as directed.

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Despite Positive Phase 3 Data, New FDA Approval Will Not Be Sought for Breast Cancer Combo
Despite positive topline progression-free survival data from the phase 3 EMBER-3 trial, Lilly will not seek broad approval for its oral SERD imlunestrant (Inluriyo) combined with the CDK4/6 inhibitor abemaciclib (Verzenio) in all patients with estrogen receptor–positive, HER2-negative advanced breast cancer. Instead, the company will pursue approval only for patients with ESR1-mutated disease.

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Does Latest Late-Stage Cancer Trial Failure Spell the End for a Once-Promising Drug Class?
Arcus and Gilead have discontinued development of domvanalimab, an anti-TIGIT antibody, in gastric and esophageal cancers after the failure of the phase 3 STAR-221 trial, which showed no improvement in overall survival compared with standard therapy. The regimen provided the same benefit as the current standard of care.

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Monoclonal Antibody Fails to Improve Survival in Triple-Negative Breast Cancer Trial
Cantargia reported no median overall survival benefit in its phase 1b/2 TRIFOUR trial of the monoclonal antibody nadunolimab plus gemcitabine/carboplatin in triple-negative breast cancer.

“Although this is not the outcome we had hoped for, we remain confident in the strong potential of nadunolimab, particularly in pancreatic ductal adenocarcinoma… where we see strong scientific rationale, robust data, and significant opportunities for impact,” said Hilde H. Steineger, CEO of Cantargia, in a news release.

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