Lilly Reports Successful Phase II NASH Trial for Tirzepatide and Discontinues Abemaciclib Development in mCRPC

On February 6, Eli Lilly and Company announced2023 PerformanceAt the time of announcement, the Phase III CYCLONE-2 study of abemaciclib in combination with abiraterone acetate and prednisone for the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC) did not meet the primary endpoint of radiographic progression-free survival (rPFS), and therefore, the development of this indication was decided to be terminated.

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This result is not surprising, as signs emerged as early as April 2023. At last year's AACR conference, Eli Lilly and Company announced the results of the Phase II CYCLONE-1 study on abemaciclib monotherapy for patients with mCRPC.

Results showed that among 44 mCRPC patients who had received a median of three lines of treatment, five patients (11.8%) exhibited soft tissue responses after receiving abemaciclib, with an objective response rate(ORR, defined as achieving complete response or partial response without concurrent bone metastasis)The rate was 6.8%, with 18 patients (40.9%) achieving stable disease (SD), and the disease control rate (DCR) was 47.7%. Additionally, the median rPFS was 2.7 months, the 6-month rPFS rate was 24.9%, the median time to prostate-specific antigen (PSA) progression was 6.5 months, and the median overall survival (OS) was 7.6 months. Such efficacy data is not convincing.

In addition to mCRPC, Eli Lilly is also exploring the efficacy of abemaciclib in combination with hormonal therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study is expected to be completed by 2025.

At the same time, Eli Lilly and Company announced the Phase II trial of tirzepatide for the treatment of non-alcoholic steatohepatitis (NASH).SYNERGY-NASH Study Meets Primary Endpoint. This is also the first clinical result of Eli Lilly's tirzepatide for the treatment of NASH to be announced. The results showed that at week 52 of treatment, the tirzepatide group had73.9% of patients achieved NASH resolution without fibrosis worsening, compared to 12.6% in the placebo group. Notably, tirzepatide was even able to reverse fibrosis.

Click to DownloadEli Lilly 2023 Earnings Report PPT