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EMA Reminds Physicians to Use Atezolizumab with Nab-paclitaxel for Treating TNBC

Advice follows the release of results from the IMpassion131 study
06 Oct 2020
Breast cancer;  Cancer Immunology and Immunotherapy

On 1 October 2020, the European Medicines Agency (EMA) reminded physicians to use atezolizumab (Tecentriq) only in combination with nab-paclitaxel and not with conventional paclitaxel when treating patients with locally advanced or metastatic triple negative breast cancer (TNBC) that cannot be surgically removed.

EMA’s advice follows the release of results from a study, IMpassion131, which did not show that combining Tecentriq with conventional paclitaxel in these patients slowed down the progression of the cancer or reduced deaths.

Tecentriq is only authorised for the treatment of TNBC in combination with nab-paclitaxel. Nab-paclitaxel is a formulation of paclitaxel that is attached to a protein that affects how the medicine works in the body.

There is no indication yet that physicians in the EU have been using paclitaxel in place of nab-paclitaxel. However, EMA’s Committee for Medicinal Products for Human Use (CHMP) would like to use this opportunity to remind healthcare professionals to follow the recommendations in the approved product information.

Tecentriq was approved for the treatment of TNBC in the EU in August 2019. A study reviewed by the CHMP at the time showed that patients whose cancer produced a certain amount of a protein called PD-L1 lived for an average of 25 months when treated with Tecentriq plus nab-paclitaxel, compared with 18 months when given placebo plus nab-paclitaxel. Patients in the Tecentriq group also lived for longer without their disease getting worse (7.5 months versus 5.3 months).

The EMA will review data from the IMpassion131 study and decide if any change is needed to the approved use of Tecentriq with nab-paclitaxel.

Tecentriq is a medicine for treating the urothelial cancer, lung cancer and TNBC. For urothelial and breast cancers, cancer cells must have a certain amount of a protein called PD-L1. For breast cancer, it is used with nab-paclitaxel.

FDA issues alert about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of TNBC 

On 8 September 2020, the US Food and Drug Administration (FDA) alerted health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab (Tecentriq) and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic TNBC showed the drug combination did not work to treat the disease.  

Atezolizumab in combination with paclitaxel is not approved for use in breast cancer. However, atezolizumab in combination with paclitaxel protein-bound (Abraxane)—a different combination therapy—is currently approved for the treatment of adult patients with locally advanced or metastatic TNBC whose tumours express PD-L1 (PD-L1 stained tumour-infiltrating immune cells of any intensity covering ≥1% of the tumour area), as determined by an FDA-approved test. Continued approval of atezolizumab in combination with paclitaxel protein-bound may be contingent on proven benefit of the treatment in additional trials.

Healthcare professionals should not replace paclitaxel protein-bound (Abraxane) with paclitaxel in clinical practice.

The trial, IMpassion131, was a phase III, multicentre, randomised, double-blind, placebo-controlled trial of atezolizumab in combination with paclitaxel compared with placebo and paclitaxel for patients with locally advanced or metastatic TNBC.

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 favoured paclitaxel plus placebo, over paclitaxel plus 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 receiving atezolizumab and paclitaxel for other approved uses should continue to receive their medication as directed by their health care professional.

Patients should talk to their doctor if they have questions or concerns. Healthcare 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 programme.

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