DISCOVERIES AND INNOVATIONS
ICON and Advarra Partner to Launch Connected “Research-Ready” Site Network Model for Faster, More Efficient Clinical Trials
CON plc and Advarra have announced a strategic partnership to create a “research-ready” connected site network model aimed at streamlining clinical trials. By integrating ICON’s global trial services with Advarra’s widely used site technologies—including CTMS, eISF, and eSource systems—the collaboration establishes a shared operating environment that reduces administrative burden, accelerates study startup, and enhances trial participation. Advarra’s Study Collaboration platform, powered by its Braid data and AI system, will provide ICON with operational intelligence to improve protocol design, forecasting, and site selection, enabling more efficient and realistic trial execution.

The partnership also focuses on expanding global access to clinical trials by equipping more research sites—including emerging and less experienced ones—with standardized technology and workflows. This approach allows sites to operate within familiar systems while minimizing duplicate work and manual processes, ultimately improving patient recruitment and retention. With seamless data integration and real-time visibility into study progress, sponsors and research teams can move trials forward more efficiently, helping accelerate the development and delivery of new therapies to patients.

THERAPEUTIC TALK
Lilly’s Jaypirca Combo Extends Survival in Phase 3 CLL Trial, Strengthening Second-Line Treatment Strategy
Eli Lilly and Company has reported positive results from its phase 3 BRUIN CLL-322 trial, showing that its non-covalent BTK inhibitor Jaypirca significantly improves progression-free survival when added to a fixed-duration regimen of venetoclax and rituximab in patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study marks the first time a phase 3 trial has successfully outperformed a venetoclax-based regimen, a commonly used second-line treatment, with early signs also pointing toward an overall survival benefit. Safety outcomes were comparable between treatment arms, with similar rates of adverse events and discontinuations.

Eli Lilly and Company reports that its BTK inhibitor Jaypirca, used in a new combination approach, could extend treatment benefits for patients with previously treated CLL.

The findings position Jaypirca as a compelling option in the evolving CLL treatment landscape, particularly as physicians seek effective, time-limited regimens for patients who have already received prior therapies. With existing BTK inhibitors increasingly used in first-line settings, venetoclax-based combinations have become standard in second-line care, creating an opportunity for Jaypirca to enhance outcomes in this space. Lilly plans to pursue regulatory approval based on these results, adding to a growing body of positive late-stage data supporting the drug’s role across multiple lines of CLL treatment.

FDA UPDATES
FDA Approves Oral IL-23 Inhibitor Icotrokinra for Moderate-to-Severe Plaque Psoriasis
The US Food and Drug Administration has approved icotrokinra (ICOTYDE), a once-daily oral interleukin-23 receptor antagonist from Johnson & Johnson, for adults and adolescents aged 12 and older with moderate-to-severe plaque psoriasis who are eligible for systemic therapy or phototherapy.

The FDA approves icotrokinra for adults and adolescents aged 12 and older with moderate-to severe plaque psoriasis who are eligible for systemic therapy or phototherapy.

Backed by results from the phase 3 ICONIC program involving approximately 2,500 patients, icotrokinra demonstrated strong efficacy, with around 70% of patients achieving clear or nearly clear skin and about 55% reaching at least a 90% reduction in disease severity by week 16. Designed as a targeted oral alternative to injectable biologics, the therapy offers a new option for patients who have not responded adequately to topical treatments. Safety findings showed adverse event rates comparable to placebo, with no new signals through 52 weeks, though patients should be monitored for infections.