CDK4/6 Inhibitor Shows Promise as Single Agent in HR+ Breast Cancer

Excerpt:

“As a single agent, abemaciclib has shown exciting potential in heavily pretreated patients with refractory, hormone-receptor (HR)–positive, HER2-negative advanced breast cancer, following phase II findings of the MONARCH 1 trial.

“Results of the single-arm study, which were presented during the 2016 ASCO Annual Meeting1, show that the CDK4/6 inhibitor induced a response rate of nearly 20% in this patient population. The median progression-free survival (PFS) was 6 months (95% CI 4.2-7.5) and the median overall survival (OS) was 17.7 months (95% CI, 16 to not reached). Previously, abemaciclib received a breakthrough therapy designation in this setting from the FDA in October 2015.”

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Lilly Announces Results from MONARCH 1 Trial of Abemaciclib Monotherapy

Excerpt:

“Eli Lilly and Company (LLY) today announced results from the MONARCH 1 Phase 2 study of abemaciclib, a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. The data, which were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting by Maura Dickler, M.D., of Memorial Sloan Kettering Cancer Center, showed that single-agent activity was observed in metastatic breast cancer patients, for whom endocrine therapy was no longer a suitable treatment option. The MONARCH 1 results (abstract #510) confirmed objective response (ORR), durability of response (DoR), clinical benefit rate (CBR) and progression-free survival (PFS).

“The single-arm study, designed to evaluate the safety and efficacy of abemaciclib monotherapy, enrolled 132 patients who were given 200 mg of abemaciclib orally every 12 hours until disease progression. Patients enrolled in the study were heavily pretreated, having experienced progressive disease on or after prior endocrine therapy, and had received prior chemotherapy with one or two chemotherapy regimens for metastatic disease. The primary objective of the trial was investigator-assessed ORR, with secondary endpoints of DoR, CBR and PFS.”

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Investigational CDK4/6 Inhibitor Abemaciclib is Active Against a Range of Cancer Types

Excerpt:

“The investigational anticancer therapeutic abemaciclib, which targets CDK4 and CDK6, showed durable clinical activity when given as continuous single-agent therapy to patients with a variety of cancer types, including breast cancer, non–small cell lung cancer (NSCLC), glioblastoma, and melanoma, according to results from a phase I clinical trial published in Cancer Discovery, a journal of the American Association for Cancer Research.

“The results of the trial supported the U.S. Food and Drug Administration (FDA) decision to grant breakthrough therapy designation to abemaciclib (previously known as LY2835219) for patients with refractory hormone receptor–positive advanced or metastatic breast cancer, according to one of the senior authors of the study, Amita Patnaik, MD, associate director of clinical research at South Texas Accelerated Research Therapeutics in San Antonio, Texas.”

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Novartis Breast Cancer Drug Set to Take on Pfizer's Ibrance

Excerpt:

“A clinical trial testing an experimental breast cancer pill from Novartis has been stopped early because of good results, boosting the Swiss company’s efforts to build up its oncology business.

“The news puts Novartis on track to compete with a similar blockbuster product from Pfizer that is already on the market.

“Novartis said on Wednesday that testing of LEE011 in combination with letrozole in the late-stage study had been halted early after it met its goal of significantly extending the time patients lived without their disease progressing.

“LEE011, or ribociclib, belongs to the same drug class as Pfizer’s Ibrance. The Novartis product now looks set to be second to market in the category, ahead of Eli Lilly’s abemaciclib, according to Berenberg Bank analysts.”

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Possible Treatment on Horizon for Advanced KRAS-Mutant NSCLC

Excerpt:

“Promising early phase clinical trials have led to the initiation of the phase III JUNIPER trial, which is assessing abemaciclib (LY2835219) for patients with previously treated KRAS-mutant lung cancer, a traditionally hard to treat genetic subtype.

“JUNIPER is an open label phase III study currently recruiting patients with stage IV non–small cell lung cancer (NSCLC) with a detectable KRAS mutation who have progressed following treatment with platinum-based chemotherapy (NCT02152631). Patients will be randomized to receive either abemaciclib or erlotinib, both with best supportive care.

“ ‘KRAS mutations are common in patients with NSCLC, but there have been few clinical advances in our treatment for these patients,’ said investigator Jonathan W. Goldman, MD, of the Department of Medicine, Hematology/Oncology, member of the Signal Transduction and Therapeutics Program Area at UCLA’s Jonsson Comprehensive Cancer Center, who explored the drug in a phase I trial.”

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Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib – a CDK 4 and 6 Inhibitor – in Advanced Breast Cancer

“Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer. This designation is based on data from the breast cancer cohort expansion of the company’s Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. Patients in this cohort had received a median of seven prior systemic treatments. These data were presented at the San Antonio Breast Cancer Symposium in 2014.”