Anti-CDK4/6 Boosts PFS in Metastatic Breast Cancer

Excerpt:

“The addition of a targeted agent to endocrine therapy for metastatic breast cancer led to unprecedented improvement in progression-free survival (PFS) that will have a ‘paradigm changing’ effect on clinical management, an investigator said here.

“Patients who received the cyclin-dependent kinase (CDK)4/6 inhibitor ribociclib in addition to letrozole (Femara) had a 44% reduction in the PFS hazard compared with patients treated with letrozole alone. The median PFS (primary endpoint) was 14.7 months with letrozole but had yet to be reached with letrozole plus ribociclib, ‘but it is expected to far exceed what the control arm did,’ Gabriel N. Hortobagyi, MD, reported at the European Society for Medical Oncology (ESMO) conference.”

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Palbociclib Efficacious in Metastatic Breast Cancer

Excerpt:

“Palbociclib can help slow the progression of advanced breast cancer, according to a study published in the Nov. 17 issue of the New England Journal of Medicine.

“Richard Finn, M.D., an assistant professor of medicine at the University of California, Los Angeles, and colleagues tested palbociclib-letrozole as a first-line treatment for estrogen-receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative . They randomly assigned 666 women to receive the or letrozole alone, and followed them for up to three years.

“At that point, the researchers found that 43.7 percent of women in the palbociclib group had either died or seen their cancer progress. That compared with 61.7 percent of women on letrozole alone. Women on the drug combination typically remained progression-free for 24.8 months, versus 14.5 months for women on letrozole. One of the most common side effects—seen in two-thirds of in this study—was neutropenia.”

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FDA Grants Ribociclib Priority Review for Frontline HR+/HER2

Excerpt:

“The FDA granted a priority review to a new drug application (NDA) for ribociclib (LEE011) for use in combination with letrozole as a frontline therapy for patients with hormone-receptor (HR)–positive, HER2-negative advanced breast cancer.

“The NDA for the CDK 4/6 inhibitor is primarily based on findings from the phase III MONALEESA-2 trial, in which combining ribociclib with letrozole reduced the risk of progression or death by 44% compared with letrozole alone in the first-line setting for HR+/HER2- advanced breast cancer (HR, 0.556; 95% CI, 0.43-0.72; P = .00000329). Under the priority designation, the NDA will be reviewed within 6 months, compared with the standard 10-month review.”

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FDA Gives Ribociclib Priority Review for Frontline HR+/HER2- Breast Cancer

Excerpt:

“The FDA has granted priority review designation to a new drug application (NDA) for ribociclib (LEE011) for use in combination with letrozole as a frontline therapy for patients with hormone-receptor (HR)–positive, HER2-negative advanced breast cancer.

“The NDA for the CDK 4/6 inhibitor is primarily based on findings from the phase III MONALEESA-2 trial, in which combining ribociclib with letrozole reduced the risk of progression or death by 44% compared with letrozole alone in the first-line setting for HR+/HER2- advanced breast cancer (HR, 0.556; 95% CI, 0.43-0.72; P = .00000329). Under the priority designation, the NDA will be reviewed within 6 months, compared with the standard 10-month review.”

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Study Finds Ribociclib Improves Progression-Free Survival for Women with Metastatic Breast Cancer

Excerpt:

“In a randomized, Phase III trial led by researchers at The University of Texas MD Anderson Cancer Center, ribociclib, in combination with the aromatase inhibitor letrozole, dramatically improved progression-free survival (PFS) of post-menopausal women with hormone receptor-positive metastatic breast cancer, compared to the hormone therapy alone.

“The study found a 44 percent improvement in PFS with ribociclib, a CDK4/6 inhibitor, and letrozole as a front line therapy. Gabriel Hortobagyi, M.D., professor of Breast Medical Oncology, presented the findings at ESMO 2016 Congress, and is the corresponding author of the New England Journal of Medicine paper.”

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Encouraging Results For Ribociclib In Advanced Breast Cancer

Excerpt:

“At the European Society for Medical Oncology (ESMO) Congress this week, investigators presented data for a new and potentially important drug, ribociclib (Novartis). This oral medication is clearly active in hormone receptor-positive (ER+ or PR+) breast cancer. The findings of the MONALEESA trial were published in the NEJM.

“The main result is that for the most common form of advanced breast cancer, adding ribociclib to letrozole significantly improved progression-free survival (PFS), as compared to adding a placebo. After a year and a half (18 months) in this randomized, controlled clinical trial, PFS among women receiving ribociclib was 63.0%, vs. 42.2% in the placebo arm. That’s a big difference, when you consider that 99% of the patients on the study have stage 4, metastatic breast cancer.”

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Palbociclib Addition to Letrozole Improved PFS in ER+/HER2- Breast Cancer

Excerpt:

“Palbociclib (Ibrance), when added to letrozole, increased the median progression-free survival (PFS) rate in patients with ER-positive, HER2-negative advanced or metastatic breast cancer by >10 months, according to results from the phase III PALOMA-2 trial presented at the 2016 ASCO Annual Meeting. 

“The risk of disease progressed was reduced by 42 with the addition of palbociclib, a CDK4/6 inhibitor, when compared with letrozole alone. The combination of palbociclib and letrozole was granted an accelerated approval in February 2015, based on the phase II PALOMA-1 study. These results from PALOMA-2 provide confirmation of the combination’s benefits in the frontline setting.

“ ‘These data represent the longest frontline improvement in median PFS seen to date in women with advanced ER+ breast cancer,’ senior study author Dennis J. Slamon, MD, PhD, chief of the Division of Hematology/Oncology in the UCLA Department of Medicine, said when presenting the findings at ASCO.”

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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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Advanced Breast Cancer Slowed with Avastin Combo (CME/CE)

Excerpt:

“Adding bevacizumab (Avastin) to letrozole (Femara) improved progression-free survival (PFS) in estrogen receptor-positive metastatic breast cancer (ER+MBC) but not other outcomes, an open-label, multicenter phase III trial showed.

“While median PFS increased by 4.6 months in patients who received combined therapy versus letrozole alone, there was no significant difference in overall survival (hazard ratio 0.87; 95% CI 0.65-1.18; P=0.188), Maura N. Dickler, MD, of Memorial Sloan Kettering Cancer Center in New York City, and colleagues reported online in the Journal of Clinical Oncology.

“In addition, there was a marked increase in grade 3 to 4 toxicities, particularly hypertension (24% versus 2%) and proteinuria (11% versus 0%), the researchers said, emphasizing that the role of bevacizumab in this setting will need to be clarified with research on predictive markers.”

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