Biologics

IO Biotech’s Cancer Vaccine Misses Trial ‘Significance’

IO Biotech is reporting that its investigational cancer vaccine Cylembio (imsapepimut and etimupepimut, adjuvanted), combined with Merck’s Keytruda (pembrolizumab), improved progression-free survival (PFS) compared with Keytruda alone in a pivotal Phase 3 trial for first-line treatment of advanced melanoma. While the results were clinically meaningful, according to IO Biotech, they narrowly missed the study’s pre-specified threshold on the endpoint’s statistical significance.

In the global trial of 407 patients, those who received the Cylembio-Keytruda combination achieved a median PFS of 19.4 months versus 11.0 months for Keytruda alone, the company says. Notably, in patients who had no prior anti–PD-1 therapy (n=371), the combination extended median PFS to 24.8 months compared with 11.0 months for the control arm, it says. The strongest benefit was seen in patients with PD-L1–negative tumors, where median PFS reached 16.6 months versus 3.0 months for Keytruda alone.

IO Biotech says the combination was well tolerated, with no new safety signals. The most common side effects in the combination arm were transient injection site reactions, reported in 56% of patients, it adds.

The company plans to meet with FDA this fall to discuss the data and potential next steps for submitting a BLA. Detailed study results will be presented at an upcoming medical meeting, 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