CDK4/6 Agent Active in Metastatic Breast Cancer

Excerpt:

“About one in five patients with post-chemotherapy metastatic breast cancer attained an objective response to single-agent therapy with the cyclin-dependent kinase (CDK)4/6 inhibitor abemaciclib, results of a phase II trial showed.

“Responses were durable, lasting an average of almost 9 months, and more than 40% of patients obtained clinical benefit. Abemaciclib’s safety and tolerability were consistent with previous clinical experience, as no new or unexpected adverse events occurred among 132 patients who received the drug.”

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Lilly’s Breast Cancer Drug Combination Succeeds Key Study

Excerpt:

Eli Lilly and Co’s combination of its experimental breast cancer drug and another widely used treatment slowed disease progression in patients who relapsed or did not benefit enough when treated with the anti-estrogen therapy.

“In August, an independent data monitoring committee recommended the late-stage study continue without modification, even though interim evaluation suggested the combination treatment was not delaying cancer progression.

“Lilly’s drug, abemaciclib, is part of the same new class of breast cancer treatments as Pfizer Inc’s Ibrance, and Novartis AG’s newly approved Kisqali.”

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In Metastatic Breast Cancer Treatment, Not All CDK Inhibitors Are Equal


Doctors prescribe drugs known as CDK inhibitors to treat some women with estrogen-receptor-positive (ER+) metastatic breast cancer. Research into these drugs is ongoing, and new, promising CDK inhibitor options are on the horizon. Here, I address the current outlook for CDK inhibitors in ER+ breast cancer.

First, some background: ER+ breast cancers comprise about 70% of all breast cancers. The name reflects the fact that cells of these cancers express estrogen receptors (ERs), which are protein features targeted by many treatment strategies for this cancer type. The estrogen receptor (ER) protein is a treatment target not only because “it is there,” but mainly because it drives tumor cell proliferation in ER+ breast cancer. The activity of the ER depends on its binding to the hormone estrogen, and treatments known as endocrine drugs aim to prevent this interaction. Some endocrine drugs inhibit the synthesis of estrogen in the body (e.g., aromatase inhibitors, such as letrozole and anastrozole), and others prevent the interaction of estrogen with ERs (e.g., ER modulators such as tamoxifen, or the pure anti-estrogen drug fulvestrant). The problem of course is that, in metastatic breast cancer, resistance develops to each and every endocrine drug used. Continue reading…


Neoadjuvant Abemaciclib Active in HR+/HER2- Breast Cancer

Excerpt:

“A neoadjuvant regimen combining the CDK4/6 inhibitor abemaciclib with anastrozole induced a response rate of 54.7% in patients with HR+/HER2-negative early-stage breast cancer, according to findings from the phase II neoMONARCH trial presented at the 2016 San Antonio Breast Cancer Symposium.

“The study also met its primary endpoint of reduction in Ki67 expression level at week 2. The abemaciclib combination yielded a geometric mean change in Ki67 from baseline to day 15 of -92.6%.”

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Abemaciclib Effective for Ki67 Reduction in Certain Postmenopausal Women with Breast Cancer

Excerpt:

“Neoadjuvant abemaciclib with or without anastrozole led to significantly greater reductions in tissue Ki67 after 2 weeks of treatment than anastrozole alone among postmenopausal women with hormone receptor–positive, HER-2–negative breast cancer, according to interim phase 2 study results presented at the European Society for Medical Oncology Congress.”

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Lilly Breast Cancer Drug Stumbles, but Trial Continues

Excerpt:

“U.S. drugmaker Eli Lilly and Co on Wednesday said it would continue a late-stage trial of its experimental breast cancer drug in combination with a widely used treatment even though an independent panel determined the combination therapy failed to meet its interim effectiveness goal.

“The independent data monitoring committee recommended the trial continue without modification through the first half of 2017 despite the fact that its interim look at the data suggested the combination treatment was not delaying progression of the disease.”

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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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