Drugs

BioNTech, OncoC4 See Good Survival Data for Lung Cancer Drug

BioNTech and OncoC4 say their investigational immunotherapy gotistobart significantly extended survival for patients with advanced squamous non–small cell lung cancer (sqNSCLC) who had exhausted standard treatment options. Results from the first stage of the global Phase 3 PRESERVE-003 trial show that gotistobart, a selective T-regulatory cell modulator also known as BNT316 or ONC-392, cut the risk of death by more than half compared with standard chemotherapy, according to the companies, adding that the therapy demonstrated a manageable safety profile.

Their analysis included 87 patients whose cancer had progressed after both PD-(L)1 immunotherapy and platinum-based chemotherapy. Among the 45 patients who received gotistobart, median overall survival had not been reached after roughly 15 months of follow-up. By contrast, patients treated with docetaxel chemotherapy lived a median of 10 months.

At one year, 63% of patients receiving gotistobart were alive, compared with 30% in the chemotherapy group, the companies say. The drug reduced the risk of death by 54%.

“Advanced squamous NSCLC remains one of the hardest lung cancers to treat,” news release says. “These early signals of prolonged survival are encouraging for patients who currently have extremely limited options.”

Gotistobart is reportedly designed to deplete tumor-infiltrating regulatory T cells — an immunosuppressive cell type — while sparing healthy tissue, a mechanism BioNTech believes may produce stronger and more durable anti-tumor responses than earlier CTLA-4–targeting therapies.

Regarding safety, treatment-related severe side effects were reported in 42% of patients receiving gotistobart and 49% of those on docetaxel, consistent with prior data, the companies say.

The study is now moving into its pivotal stage, which will enroll about 500 patients across more than 160 sites worldwide. Gotistobart is also being tested in ovarian, prostate and other solid tumors, both alone and in combination with BioNTech’s investigational mRNA-based therapies, according to the companies.

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