Advertisement
Home FDA Alerts FDA Alert: Efficacy and Potential Safety Concerns with Atezolizumab + Paclitaxel in...

FDA Alert: Efficacy and Potential Safety Concerns with Atezolizumab + Paclitaxel in Breast Cancer

The U.S. Food and Drug Administration is warning health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab (Tecentriq®; Genentech/Roche) and paclitaxel (Taxol®; Bristol Meyers Squibb/BMS) in patients with previously untreated inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.

Breast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year [1] TNBC represents ~15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer. [2][3][4] It is defined by the lack of expression and/or amplification of the targetable receptors for estrogen, progesterone, and HER2 amplification. [5[ Patients with metastatic TNBC generally experience rapid progression and shorter OS compared to other subtypes of breast cancer. [3]

The FDA warns that health care professionals should not replace paclitaxel protein-bound (Abraxane) with paclitaxel in clinical practice.

Combination not approved
Atezolizumab in combination with paclitaxel is not approved for use in breast cancer. However, atezolizumab in combination with paclitaxel protein-bound particles (Abraxane®; Bristol Meyers Squibb/BMS) —a different combination therapy—is currently approved for the treatment of adult patients with mTNBC whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test.

Continued approval of atezolizumab in combination with paclitaxel protein-bound may be contingent on the proven benefit of the treatment in additional trials.

The FDA warns that health care professionals should not replace paclitaxel protein-bound (Abraxane) with paclitaxel in clinical practice.

IMpassion131 trial
The trial, IMpassion131, was a phase III, multicenter, randomized, double-blind, placebo-controlled trial of atezolizumab in combination with paclitaxel compared with placebo and paclitaxel for patients with mTNBC.

In this clinical trial, treatment with atezolizumab and paclitaxel did not significantly reduce the risk of cancer progression and death compared with placebo and paclitaxel in the PD-L1-positive population. Additionally, interim overall survival results favored paclitaxel + placebo, over paclitaxel + atezolizumab in both the PD-L1-positive population and total population.

FDA will review the findings of IMpassion131 and will communicate new information regarding the IMpassion131 results and any potential changes to prescribing information. FDA is also evaluating the use of atezolizumab and paclitaxel in ongoing clinical trials for breast cancer and will recommend additional changes as appropriate.

Patients taking atezolizumab and paclitaxel for other approved uses should continue to take their medication as directed by their health care professional.

Patient concern
Patients are encouraged to talk to their doctor if they have questions or concerns. Health care professionals and patients should report any adverse events or side effects related to the use of these products and other similar products to FDA’s MedWatch Adverse Event Reporting program.

MedWatch Adverse Event Reporting program
Complete and submit the report online; or
Download and complete the form (MEDWATCH Consumer Voluntary Reporting) then submit it via fax at 1-800-FDA-0178. [Form FDA-3500B_03-06-19]

Highlights of prescribing information
Atezolizumab (Tecentriq®; Genentech/Roche) [Prescribing Information]
Paclitaxel (Taxol®; Bristol Meyers Squibb/BMS) [Prescribing Information]
Paclitaxel protein-bound particles (Abraxane®; Bristol Meyers Squibb/BMS [Prescribing Information]

Clinical trials
A Study of Atezolizumab Plus Nab-Paclitaxel or Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (EL1SSAR) – NCT04148911
A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple-Negative Breast Cancer (TNBC) (IMpassion131) – NCT03125902

Reference
[1] World Health Organization: Globocan 2018 – Breast Cancer Factsheet. [Internet; cited 24 July] Available online. Last accessed on September 8, 2020.
[2] Yao H et al. Triple-negative breast cancer: is there a treatment on the horizon? Oncotarget. 2017;8(1):1913–1924.
[3] BreastCancer.org. What is Triple-Negative Breast Cancer? [Internet; cited 24 July] Available Online. Last accessed September 9, 2020.
[4] Cancer Treatment Centers of America. Triple-negative breast cancer risk factors. [Internet; cited 24 July] Available online. Last accessed on September 9, 2020.
[5] Pal SK et al. Triple-negative breast cancer: unmet medical needs. Breast Cancer Res Treat. 2011;125(3):627–636.

 

 

Advertisement