Articles related to CLINICAL TRIALS

In this 15-minute CME activity, two experts provide a rundown of multiple disease factors to consider, evolving clinical trial data, and the various therapeutic options available in the second and subsequent lines of therapy for patients with locally advanced or metastatic urothelial carcinoma.

In an interim look at the SKYSCRAPER-01 study, investigators found tiragolumab plus atezolizumab didn’t meaningfully slow tumor progression compared to atezolizumab alone in patients with advanced, newly diagnosed non-small cell lung cancer (NSCLC). Tiragolumab has now fallen short in two phase 3 lung cancer trials, having already missed its study objectives in advanced SCLC earlier this year.

A phase II study of durvalumab alone or combined with the anti-CD73 monoclonal antibody oleclumab or anti-NKG2A monoclonal antibody monalizumab as consolidation therapy in patients with unresectable stage III NSCLC and no progression after concurrent chemoradiotherapy. With a median follow-up of 11.5 months, both combinations increased ORR and prolonged PFS versus durvalumab alone. Safety was similar across arms with no new or significant safety signals identified with either combination.

Oral azactidine substantially improved survival compared with placebo irrespective of baseline MRD status, and the survival benefit with oral-AZA relative to placebo was greater in the baseline MRD+ subgroup than in the MRD− subgroup. Multivariate analysis confirmed the significant independent treatment effect of oral-AZA vs. placebo on OS and RFS when controlling for MRD status at baseline.

Perelman School of Medicine’s David Teachey, MD, reviews outcomes and implications from two recent Children’s Oncology Group trials and describes current research with daratumumab and CAR T-cell therapy.

Phase 1 trial using an autologous CAR-T cell therapy that targets the oncofetal antigen Claudin-6 (CLDN6) — and CARVac (BioNTech), a CLDN6-encoding mRNA-based vaccine designed to enhance CAR T-cell activity. Data show encouraging clinical activity for an investigational CAR T-cell therapy alone or in combination with an amplifying mRNA vaccine for patients with solid tumors.