immunotherapy

An FDA panel voted 10-3 that IGNYTE trial results for RP1 plus nivolumab are clinically meaningful, days ahead of an August 2 decision.

HARMONi-6 showed Akeso's PD-1/VEGF bispecific cut the risk of death by 34% versus tislelizumab plus chemotherapy, and reached the ASCO plenary for the first time for a China-originated cancer drug.

IGNYTE trial data show 83.5% of responders alive at three years; Replimune plans third BLA resubmission after two FDA rejections.

Atezolizumab becomes the first therapy cleared for use only in patients whose blood tests reveal molecular residual disease after bladder removal surgery.

A UK trial of preoperative pembrolizumab for MMR-deficient colorectal cancer shows zero relapses across all 32 patients after nearly three years of follow-up.

Six-year follow-up from a 16-patient Phase 1 trial of autogene cevumeran shows unprecedented survival rates in one of oncology's deadliest cancers, now entering a global Phase 2 trial.

A first-in-human trial published in Nature shows BioNTech's individualized neoantigen mRNA vaccine produces durable T cell immunity and sustained disease control in aggressive breast cancer.

An Fc-engineered CD40 agonist injected into a single tumor triggered systemic immune responses that eliminated cancer across the body in two patients, with expanded trials now under way at Memorial Sloan Kettering and Duke.

A redesigned CD40 agonist antibody injected into a single tumor triggered body-wide immune responses that eliminated all metastases in two patients, with nearly 200 now enrolled in follow-up trials.

A two-vector system inserts a CAR transgene at the TRAC locus inside the body, generating functional cancer-killing T cells without ex vivo manufacturing or lymphodepletion.

FDA approves pembrolizumab for a subset of ovarian cancer patients after Phase 3 KEYNOTE-B96 trial shows the first overall survival benefit ever demonstrated by an immunotherapy in this setting.

Five-year KEYNOTE-942 trial data show Moderna and Merck's individualized neoantigen mRNA vaccine maintains a 49% reduction in melanoma recurrence or death.