Cyclin-dependent kinase inhibitors(Boehringer Ingelheim)

Nearly two months after Eli Lilly secured an expanded approval indication for its cancer drug Verzenio, the company unveiled final data from the MONARCH 3 trial that won the latest nod from the U.S. Food and Drug Administration for the treatment of some breast cancer patients. Nearly two months after Eli Lilly secured an expanded approval indication for its cancer drug Verzenio, the company unveiled final data from the MONARCH 3 trial that won the latest nod from the U.S. Food and Drug Administration for the treatment of some breast cancer patients. During a presentation at the American Association for Cancer Research in Chicago this weekend Lilly revealed that Verzenio (abemaciclib), a cyclin-dependent kinase inhibitor, provided even longer progression-free survival than originally believed. Last fall Eli Lilly released interim-data from the MONARCH 3 trial that showed PFS was estimated at 14 months. Now though data shows Verzenio in combination with an aromatase inhibitor (AI) provides progression-free survival of 28 months. “That’s a significant prolongation in progression-free survival that is important for the lives of patients,” Levi Garraway, senior vice president of global development and medical affairs at Eli Lilly told BioSpace in an exclusive interview. “We’ve been happy with the news that this gives women with breast cancer one more option.” In February the FDA gave approval for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. That approval marked the third time the FDA gave the drug the green light since its first regulatory win in September 2017. By adding abemaciclib to endocrine therapy as part of a treatment regimen, Eli Lilly said the program demonstrated improved progression-free survival in patients with HR+/HER2-negative breast cancer. In patients with measurable disease, the objective response rate was 55.4 percent in the abemaciclib arm and 40.2 percent in the placebo arm, according to data. Within the MONARCH 2 and MONARCH 3 clinical trial subgroup populations, researchers at Eli Lilly identified certain clinical characteristics of the disease that typically confer a less favorable prognosis. Eli Lilly believes this information may help clinicians optimize treatment decisions, including the use of CDK4 & 6 inhibitors, and potentially provide the groundwork for more individualized therapy. During the conference Garraway said he engaged with several doctors about the use of cyclin-dependent kinases inhibitors in the treatment of breast cancer. He said the response they have seen from prescribers is positive, which indicates there is a path for cyclin-dependent kinases inhibitors. “These doctors, they’ve been seeing some positive moves and are gaining confidence in its (Verzenio) use,” Garraway said. With the success that Eli Lilly has had with Verzenio, the company now aims to determine if it can be used as a treatment in other types of breast cancer, as well as other cancer indications. Currently, the company has Verzenio in a study in the high-risk adjuvant breast cancer setting, as well as an ongoing Phase II study in Her2+ breast cancer. Garraway said data from the mid-stage trial is expected by the end of the year. While Garraway did not provide many details on the Phase II study, He said it was designed so that if the data readout is strong enough there is a chance Eli Lilly could seek regulatory approval on that data alone. But, he quickly noted that it depends on whether or not there is a large enough of an effect from the treatment for the company to go into regulatory discussions as opposed to a Phase III study. “There’s a biological rationale for the testing and we’re looking forward to seeing the results later this year,” Garraway said. For potential uses outside of breast cancer Garraway would not disclose what areas the company is exploring with Verzenio, he said the company has identified some areas “that are worth the investment.” Not related to Eli Lilly’s presentations at AACR, this morning the company announced a partnership with Boehringer Ingelheim and the University of Oxford to investigate the effects of Jardiance on the progression of kidney disease and the occurrence of cardiovascular death, in adults with established chronic kidney disease with and without diabetes. The primary outcome of the study is to assess the effect of Jardiance on time to clinically relevant kidney disease progression or cardiovascular death.