“This 8,000-patient trial is the largest oncology trial we've ever conducted, and it is on track to be fully enrolled by early 2026.”

In context

“arget. In other updates from cardiometabolic health, we submitted our once-weekly insulin called insulin efsitora alfa in the U.S. for treatment of type 2 diabetes and we announced plans to initiate 2 Phase III trials with baricitinib in type 1 diabetes. From the early phase portfolio, we look forward to presenting Phase II data from our selective amylin agonist eloralintide at Obesity Week in November. Moving to oncology. We're very pleased to have received U.S. FDA approval of imlunestrant under the brand name Inluriyo as a monotherapy for ER-positive, HER2-negative, ESR1 mutated metastatic breast cancer. Imlunestrant is also being studied in an ongoing Phase III trial called EMBER-4, which compares imlunestrant to the standard of care endocrine therapy in high-risk early breast cancer. This 8,000-patient trial is the largest oncology trial we've ever conducted, and it is on track to be fully enrolled by early 2026. The positive results in the metastatic setting provided an important signal that imlunestrant could have a role in early breast cancer, where we believe an oral SERD could have the largest patient impact. Also in oncology, we top lined the study readout from the third positive Phase III trial of pirtobrutinib in the BRUIN CLL development program. In BRUIN CLL-313, a trial of pirtobrutinib compared to chemoimmunotherapy in treatment naive CLL/SLL, pirtobrutinib demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival. Pirtobrutinib demonstrated the most compelling effect size ever observed for a single BTK inhibitor in a treatment-naive CLL study compared to this comparator. We look forward to sharing these data at an upcoming medic”