Drugs

Akeso’s Ivonescimab Meets Endpoint in Lung Cancer

Akeso says its first-in-class PD-1/VEGF bispecific antibody ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous non-small cell lung cancer. The HARMONi-6 (AK112-306) trial showed that ivonescimab combined with chemotherapy significantly outperformed a control regimen of BeiGene’s Tevimbra (tislelizumab-jsgr) plus chemotherapy, extending progression-free survival (PFS) in a statistically significant and clinically meaningful way, according to the company. The findings were confirmed during the study’s first pre-specified interim analysis by an independent data monitoring committee.

In the head-to-head trial involving 532 patients, ivonescimab delivered clear PFS benefits across both PD-L1-positive and PD-L1-negative subgroups, the company says. Importantly, the combination therapy maintained a favorable safety profile, with no new safety signals emerging. Rates of serious adverse events and high-grade bleeding were comparable to the control group, it adds.

HARMONi-6 is the third successful Phase 3 trial for ivonescimab in the treatment of lung cancer and the second to show superiority over PD-1 inhibitors. This reinforces the drug’s potential to become a next-generation standard of care in non-small cell lung cancer treatment, according to Akeso. More detailed results from the HARMONi-6 study will be presented at a major medical conference later this year, it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome