FDA Panel Votes Against Broad Talazoparib-Enzalutamide Label in Prostate Cancer
An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib (Talzenna) plus enzalutamide (Xtandi) for all patients with metastatic castration-resistant prostate cancer (mCRPC). In an 8-0 vote, members of the Oncologic Drugs Advisory Committee (ODAC) said the available data from the TALAPRO-2 trial do not support a favorable risk-benefit […]
Immune Checkpoint Inhibitor-Chemo Combo Boosts OS in Advanced Endometrial Cancer
SAN DIEGO — The addition of an immune checkpoint inhibitor (ICI) to chemotherapy up front improved overall survival (OS) in patients with advanced or recurrent endometrial cancer, regardless of mismatch repair (MMR) status, according to two trials. In the phase III RUBY Part 1, patients treated with dostarlimab (Jemperli) and chemotherapy had a median OS […]
First-Line Nivolumab Plus Chemo Approved for Bladder Cancer
The FDA approved the PD-1 immune checkpoint inhibitor nivolumab (Opdivo) in combination with cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma, the agency announced Thursday. Approval was based on results from the phase III CheckMate-901 trial, which were presented last year at the European Society for Medical Oncology […]
Novel Antibiotic Combo Bests Meropenem for Complicated UTIs
Cefepime-taniborbactam, an investigational beta-lactam and beta-lactamase inhibitor combination, was superior to meropenem for the treatment of hospitalized patients with complicated urinary tract infection (UTI), including acute pyelonephritis, a phase III randomized study showed. In the microbiologic intention-to-treat (ITT) population, the composite microbiologic and clinical success rate with the combination at test-of-cure (trial days 19 to […]
High Response Rates in Psoriasis With Oral IL-23 Inhibitor
An oral interleukin (IL)-23 inhibitor for psoriasis produced 16-week response rates as high as 79% in moderate-to-severe plaque psoriasis, a prospective phase II trial showed. The drug (JNJ-77242113) achieved response rates of 37% to 79% across five dose levels. In contrast, patients treated with placebo had a 9% response rate at 16 weeks. The most […]
JAK1 Inhibitor Shows ‘Remarkable’ Activity in T-Cell Lymphoma
Treatment with a novel, oral JAK1 tyrosine kinase inhibitor induced rapid and durable responses in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), findings from a single-arm phase II study showed. Among 88 heavily pretreated patients evaluable for efficacy, 44% (95% CI 34-55) responded to single-agent golidocitinib, with 24% (95% CI 15-34) achieving a […]
JAK Inhibitor Preserves Beta-Cell Function in Early Type 1 Diabetes
A Janus kinase (JAK) inhibitor helped preserve beta-cell function in people with recent-onset type 1 diabetes, the phase II BANDIT trial found. Meeting the study’s primary endpoint, daily baricitinib (Olumiant) maintained a significantly higher average mixed-meal-stimulated C-peptide level at week 48 compared with placebo (0.65 vs 0.43 nmol/L/min, P=0.001), according to Thomas Kay, MBBS, PhD, […]
Targeting New Pathways to Improve Outcomes in Renal Cell Carcinoma
NASHVILLE, Tenn. — Building on the existing immune checkpoint inhibitor (ICI) platform, new treatment strategies for renal cell carcinoma (RCC) seek to adapt the cancer’s immunity cycle to inform development of more effective therapies, according to a review presented here. Limited options exist beyond anti-VEGF and ICI-based strategies for patients with advanced disease, particularly those […]
Novel Aldosterone Synthase Inhibitor Cuts Albuminuria in Phase II Trial
PHILADELPHIA — An oral investigational aldosterone synthase inhibitor (ASI) cut albuminuria by nearly 40% in people in chronic kidney disease (CKD) in a phase II trial. The 10-mg dose of ASI BI 690517 yielded an average 37.4% (95% CI -52.2 to -18.2%) greater reduction in urine albumin-creatinine ratio (UACR) from baseline to week 14 compared […]
Adding Atezolizumab Improves Survival in Advanced Cervical Cancer
First-line treatment with the anti-PD-L1 inhibitor atezolizumab (Tecentriq) combined with bevacizumab (Avastin) and platinum-based chemotherapy significantly improved survival in patients with metastatic or recurrent cervical cancer, according to results of the phase III BEATcc trial. The median progression-free survival (PFS) was 13.7 months with added atezolizumab compared with 10.4 months with the standard bevacizumab plus […]