“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.”
“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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“The Food and Drug Administration (FDA) has granted an expanded indication for the cyclin-dependent kinase 4/6 inhibitor palbociclib (Ibrance). The drug is now approved for use in combination with fulvestrant in women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer whose disease progressed following endocrine therapy.
“Palbociclib was initially approved in February 2015 for the treatment of estrogen receptor–positive, HER2-negative metastatic breast cancer, in women who had not yet received endocrine therapy. The new approval was granted under the FDA’s breakthrough therapy designation.
“The additional indication for palbociclib is based on results from the PALOMA-3 trial, which was stopped early in April 2015 after an interim analysis showed benefit in combination with fulvestrant when compared to fulvestrant and placebo.”
“Palbociclib (Ibrance, Pfizer), the first CDK4/6 inhibitor to be approved for the treatment of breast cancer, has been welcomed by experts for its role in improving outcomes in patients with endocrine-resistant breast cancer.
“The drug should a significant improvement in progression-free survival (PFS) when it was added to fulvestrant (Faslodex, AstraZeneca) in the phase 3 PALOMA 3 trial, as reported recently by Medscape Medical News. The addition of palbociclib to fulvestrant increased median PFS to 9.2 months in patients with estrogen receptor (ER)–positive/HER2-negative endocrine-resistant breast cancer compared with 3.8 months in the placebo-fulvestrant group (P < .001).
“The overall survival data are still immature.
“The full results have now been published in print in the July 16 issue of the New England Journal of Medicine.
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“The addition of palbociclib to letrozole during first-line treatment significantly extended PFS in post-menopausal patients with ER-positive, HER-2–negative advanced breast cancer, according to final results of a randomized, open-label, phase 2 trial presented at the American Association for Cancer Research annual meeting.
“Palbociclib (PD-0332991, Pfizer), an inhibitor of cyclin-dependent kinases (CDK) 4 and 6, prevents DNA synthesis by blocking cell cycle progression. Results of preclinical studies showed HR-positive breast cancer cells are dependent on CDK-4/6 for growth, and a phase 1 study showed the combination of palbociclib and the antiestrogen drug letrozole appeared to be a safe, effective combination.”
Editor’s note: “PFS” stands for “progression-free survival.” It refers to a period of time in which a cancer patient does not experience worsening of his/her disease. In the clinical trial described here, a combination of two drugs —palbociclib and letrozole—extended PFS for some people with ER-positive, HER-2-negative advanced breast cancer.
“The novel cell cycle inhibitor selective for the cyclin-dependent kinases CDK4 and CDK6 (CDK4/6), LY2835219, shows promise for metastatic breast cancer, according to a study presented at the annual meeting of the American Association for Cancer Research, held from April 5 to 9 in San Diego.
“Amita Patnaik, M.D., from South Texas Accelerated Research Therapeutics in San Antonio, and colleagues conducted a phase I study with expansion cohorts to assess the safety, pharmacokinetics, and antitumor activity of LY2835219 in five tumor types. LY2835219 was administered to the expansion cohorts (132 patients) every 12 hours on days one to 28 of a 28-day cycle.”
Editor’s note: LY2835219 is a new drug that shows promise for treating metastatic breast cancer.
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