FDA grants fast review for Roche's Tecentriq in tough-to-treat Triple Negative Breast cancer

Roche/Genentech’s new drug Tecentriq (atezolizumab) wins FDA priority review as a part of the regimen for the treatment of tough-to-treat Triple Negative Breast Cancer (TNBC). The drug will be used in combination with Celgene chemo med Abraxane (nab-paclitaxel) in previously untreated patients whose tumors express biomarker PD-L1.

A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

Triple-negative breast cancer is the term used to describe breast cancers that lack estrogen- and progesterone-receptor expression and do not overexpress human epidermal growth factor receptor 2 (HER2). It is more aggressive and harder to treat, it is also more likely to spread and recur. Approximately 15% of breast cancers are triple-negative based on the results of diagnostic tests.

The company’s supplemental Biologics License Application (sBLA) is based on the results of phase III IMpassion130 study, involving 902 patients with advanced breast cancer. The results demonstrated that Tecentriq plus nab-paclitaxel as an initial (first-line) treatment for unresectable locally advanced or metastatic TNBC increased the median progression-free survival (PFS) to 7.2 months instead of 5.0 months as compared to nab-paclitaxel alone group. In a subgroup analysis of PD-L1-positive population, the median survival was further increased to 7.5 months vs. 5.0 months.

The drug combination improved clinically meaningful overall survival in the PD-L1-positive population (25.0 months vs. 15.5 months). The safety profile of the drug combination was as per that reported for individual drugs. Currently, Genentech has seven ongoing phase III studies investigating Tecentriq in patients who are in various stages of TNBC.

The results of the study were presented at the European Society for Medical Oncology (ESMO) Congress and published in the October issue of New England Journal of Medicine.

“Tecentriq in combination with nab-paclitaxel has the potential to meaningfully advance treatment for people with PD-L1-positive, metastatic triple-negative breast cancer. People need more options for this type of breast cancer, which is particularly difficult to treat,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are working closely with the FDA to bring this Tecentriq combination to people with PD-L1-positive, metastatic triple-negative breast cancer as soon as possible.”

It is expected that FDA will give its decision on approval by March 12, 2019. If approved, this will be the first cancer immunotherapy regimen for the treatment of PD-L1-positive, metastatic TNBC. 

Genentech press release

Full Text-New England Journal of Medicine

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Weight loss decreases breast cancer risk in postmenopausal women

October is breast cancer awareness month, which an annual campaign to increase the awareness about the deadly disease. With over 2 million new cases every year, it is the most prevalent cancer in women. Although breast cancer runs in families, there are other lifestyle and environmental factors which increase the risk of breast cancer.

Obesity increases the risk of postmenopausal breast cancer; the risk is 1.5 times higher in overweight women and about 2 times in obese women than healthy weight women. The association between weight loss and incidence of breast cancer is inconsistent, and few studies have evaluated the association between the two.

 A recent observational study by Chlebowski RT et al. published in Cancer, the peer-reviewed journal of the American Cancer Society reported that women decreased the risk of breast cancer by 12% if they lost weight in 3 years as compared to the ones whose weight remained stable.

“Obesity is associated with increased risk of incident postmenopausal breast cancer,” Rowan T. Chlebowski, MD, Ph.D., research professor in the department of medical oncology and therapeutics research at City of Hope National Medical Center, and colleagues wrote. “Because approximately one-third of postmenopausal women in the United States are obese, obesity represents a common and potentially modifiable factor related to breast cancer outcome. However, it has not been established that weight loss in postmenopausal women decreases breast cancer incidence or breast cancer mortality.”

The researchers from the Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, California used data from the Women’s Health Initiative (WHI) Observational Study to study the association.

The study included 61,335 postmenopausal women with no prior history of breast cancer and normal mammogram with body weight and height measured and body mass index (BMI) calculated at baseline and after 3 years.

At the end of 3 years, the analysis was based on 3 weight categories: stable, 5% increase or 5% decrease.

The study participants were between 50 to 79 years, and the mean follow-up duration was 11.4 years, during which the researchers observed 3,061 cases of breast cancer.

Women (n = 8175) who lost weight faced a 12% decreased risk of breast cancer as compared to women whose weight remained stable (n = 41,139) (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.78‐0.98; P = .02). The association remained the same even after adjustment for mammography.

The mean time to develop breast cancer was 6.5 years after the 3-year weight determination.

Women who gained (≥5%) weight (n = 12,021) were not associated with increased risk of breast cancer (HR, 1.02; 95% CI, 0.93‐1.11) but did show a slightly higher incidence of triple‐negative breast cancer (HR, 1.54; 95% CI, 1.16‐2.05).

“Our study indicates that moderate, relatively short-term weight reduction was associated with a statistically significant reduction in breast cancer risk for postmenopausal women,” said Dr. Chlebowski in Wiley press release. “These are observational results, but they are also supported by randomized clinical trial evidence from the Women's Health Initiative Dietary Modification trial where, in a randomized clinical trial setting, adopting a low-fat dietary pattern that was associated with a similar magnitude of weight loss resulted in a significant improvement in breast cancer overall survival. These findings, taken together, provide strong correlative evidence that a modest weight loss program can impact breast cancer.”

Here is the visual abstract of the study.

Abstract

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