ACT Brief: Rethinking Representation in Cancer Trials, Positive Phase IIb SLE Data, and a Major Obesity Drug Partnership

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In the fifth and final part of our video interview series, Shanthi Sivendran, MD, MSCR, MBA, senior vice president for cancer care support at the American Cancer Society, discusses the structural challenges limiting representative enrollment in US cancer trials. Sivendran highlights how trials conducted largely outside the US or concentrated in urban centers can fail to reflect the populations most affected by specific cancers, citing EGFR-positive lung cancer as an example where enrollment must align with disease epidemiology to support regulatory approval and meaningful innovation.
• Johnson & Johnson reported positive Phase IIb results from the JASMINE trial evaluating nipocalimab in adults with systemic lupus erythematosus. The 52-week, randomized, double-blind, placebo-controlled study met its primary endpoint at 24 weeks and achieved key secondary and exploratory endpoints, including signals supporting steroid-sparing potential. J&J stated the safety and tolerability profile was consistent with prior studies and plans to present full results at a future medical conference.
• Nimbus Therapeutics announced a multi-year research collaboration and exclusive license agreement with Eli Lilly to develop oral therapies for obesity and metabolic disease. Under the agreement, Nimbus will receive upfront and near-term milestone payments totaling $55 million, with eligibility for up to $1.3 billion in development and commercial milestones, along with tiered royalties. The collaboration builds on a prior partnership and combines Nimbus’ computational drug design capabilities with Lilly’s metabolic disease development expertise.

That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.