Guideline: FDA approves an immunotherapy treatment for some patients with triple-negative breast cancer
Summary
THIS INFORMATION HAS BEEN UPDATED: In August 2021 Roche voluntarily withdrew their FDA accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumours express PD-L1.
The FDA approved the use of the immunotherapy drug atezolizumab (Tecentriq) in combination with the chemotherapy agent nab-paclitaxel (Abraxane) for certain patients with advanced triple-negative breast cancer. (5/26/19)
Relevance
This article is most relevant for People with metastatic, triple-negative breast cancer
Relevance: High
Research Timeline: Post Approval
Media Ratings
Who covered this study?
Medscape
FDA Approves First Immunotherapy for Breast Cancer: Atezolizumab for Triple-Negative Disease
This article rates 5.0 out of 5 stars
Healio
FDA approves Tecentriq combination for PD-L1-positive, triple-negative breast cancer
This article rates 3.0 out of 5 stars
Contents
| At a glance | Guidelines |
| Findings | Questions for your doctor |
| Clinical trials | In-depth |
| Media | Resources and references |
STUDY AT A GLANCE
This study is about:
approval of the drug Tecentriq for treatment of some advanced triple-negative breast cancers.
THIS INFORMATION HAS BEEN UPDATED: In August 2021 Roche voluntarily withdrew their accelerated approval for Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or triple-negative breast cancer (mTNBC) whose tumours express .
Why is this study important?
On March 8, 2019, the U.S. Food and Drug Administration () granted accelerated approval of atezolizumab (Tecentriq) in combination with the chemotherapy agent nab-paclitaxel (Abraxane) for advanced . Tecentriq is the first drug known as an "immune checkpoint inhibitor" approved for breast cancer.
Study findings:
Atezolizumab (Tecentriq) is a type of and nab-paclitaxiel (Abraxane) is a type of chemotherapy. The approved the combination of these two drugs as a first line treatment for locally advanced or triple-negative breast cancer.
Tecentriq is approved for people whose breast cancers express “programmed death-ligand 1” (), a protein that may help cancers avoid detection by the immune system. At the same time, the also approved a tumor test, a called VENTANA (SP142). This test looks for expression of in cancers and is used to predict which tumors will respond to Tecentriq.
In the clinical trial, patients who received Tecentriq and Abraxane had progression free survival of 7.5 months compared to 5.5 months among patients who received Abraxane without Tecentriq.
Among patients with PD-LI-positive tumors, the median progression free survival was 7.5 months and 5.0 months respectively. Patients who had positive tumors and who received Tecentriq and Abraxane survived about 10 months longer than patients who did not receive Tecentriq.
As with most cancer medicines, the combination of Tecentriq and Abraxane may cause side effects.
The most common side effects were:
- hair loss: 56.4%
- nausea: 46%
- cough: 24.8%
- peripheral neuropathy (numbness or pain in the feet or hands): 47%
- neutropenia (low white blood cell counts): 20.8%
- fever: 18.8%
- hypothyroidism (underactive thyroid): 13.7%
35% of the breast cancer patients treated with Tecentriq and Abraxane had severe side effects compared to 30% who had only Abraxane. Severe side effects include inflammation of the lung and liver (13%).
What does this mean for me?
If you’ve been diagnosed with locally advanced or triple-negative breast cancer, you may want to talk to your doctor about testing of your breast cancer and whether the Tecentriq plus Abraxane treatment combination is right for you.
It’s important to know that Tecentriq did not work for all patients with advanced breast cancer. On average, patients who received Tecentriq had 2 ½ months longer “progression-free survival” than patients who did not receive Tecentriq. On average, patients who received Tecentriq survived 10 months longer than patients who did not receive Tecentriq. Patients who received Tecentriq were more likely to have serious side effects.
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This article is relevant for:
People with metastatic, triple-negative breast cancer
This article is also relevant for:
men with breast cancer
people with triple negative breast cancer
people with a genetic mutation linked to cancer risk
people with breast cancer
people with metastatic or advanced cancer
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IN-DEPTH REVIEW OF RESEARCH
Study background:
() accounts for approximately 15–20% of all breast cancers. is associated with earlier age of onset, aggressive clinical treatments, and a poorer prognosis compared to hormone receptor- and breast cancers. Given the lack of effective treatments for , researchers have focused on increasing the therapeutic options for patients.
The immune system has a key influences on the course of . Clinical trials have sought to better understand and define the role of immune checkpoint inhibitors as a treatment for . (Immune system checkpoint inhibitors are drugs that prevent malignant cells from evading the immune system). The culmination of these studies was the phase III IMpassion 130 trial. The iMpassion 130 trial showed an overall survival benefit in patients with advanced who were treated with the immune checkpoint inhibitor atezolizumab in combination with chemotherapy compared to chemotherapy alone.
This XRAYS review provides an update on research that we first covered in 2017.
Researchers of this study wanted to know:
Whether the combination of the inhibitor atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) compared to nab-paclitaxel alone increased progression-free survival in patients with locally advanced or TNBC. Progression-free survival is the period when a cancer doesn’t grow.
Population(s) looked at in the study:
Patients with untreated TNBC who participated in the IMpassion130 trial were randomly assigned to receive atezolizumab plus nab-paclitaxel (451 patients) or plus nab-paclitaxel (452 patients). Patients continued their treatment regimens until their disease progressed or an unacceptable level of side effects occurred. Median follow-up timewas 12.9 months.
Researchers looked at the data from patients by the following groupings:
- whether they did or did not receive or nab-paclitaxel therapy
- the presence or absence of liver metastases at the beginning of the clinical trial.
- whether or not their tumor expressed programmed death ligand 1 () protein at the beginning of the clinical trial.
The two primary trial goals were to determine progression-free survival (the time before tumors grew) in the population treated with atezolizumab and PD-L1-positive subgroup, and overall survival (the time before death) in the population treated with atezolizumab. If the findings related to overall survival were significant, they would then look at the impact of this treatment on the overall survival in the PD-L1-positive subgroup.
Study findings:
Patients who received the combination therapy showed a clinically meaningful median PFS of 7.2 months compared to 5.5 months with chemotherapy alone. One-year progression-free survival rates were 29% and 16% respectively. Among patients with PD-LI-positive tumors, median progression-free survival was 7.5 months and 5.0 months respectively.
Median overall survival was 21.3 months with combination therapy and 17.6 months with nab-paclitaxel alone. A positive overall survival outcome was achieved only in PD-L1-positve patients. In these patients, median overall survival was 25.0 months compared to 15.5 months for patients with PD-L1-negative tumors.
Almost 16% of patients who received the combination therapy had to stop treatment due to adverse effects, compared to 8.2% of those receiving nab-paclitaxel alone.
Limitations:
The results of IMpassion130 offer hope for as effective treatment of TNBC. However, researchers raised a number of questions including which tumors should be tested for expression, whether nab-paclitaxel is the best chemotherapy to be used with atezolizumab, and whether atezolizumab alone may be best for some patients.
Conclusions:
Treatment with atezolizumab plus nab-paclitaxel increased progression-free survival in patients with TNBC whose tumors were PD-L1-positive.
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Posted 5/26/19
Expert Guidelines
National Comprehensive Cancer Network (NCCN) guidelines for treatment of advanced or TNBC includes the following:
- Genetic testing:
- All people diagnosed with at any age meet guidelines for genetic counseling and testing.
The NCCN lists the following as preferred treatments for TNBC:
- therapy:
- For people with an inherited or mutation: (Lynparza) or ().
- For people without an inherited or mutation: chemotherapy.
- Second-line therapy:
- For people with but who test HER2-low: fam-trastuzumab deruxtecan-nxki (Enhertu).
- For people with who are not HER2-low: sacituzumab govitecan (Trodelvy) or chemotherapy.
- Third -ine or higher therapy:
- The NCCN recommends based on testing.
Updated: 02/23/2024
Questions To Ask Your Doctor
- How do I get testing of my breast cancer?
- Are there other tumor tests that may help guide my treatment?
- Is the Tecentriq plus Abraxane combination treatment an option for my type of breast cancer?
- What are the side effects that I might experience with the Tecentriq plus Abraxane combination treatment?
- Are there other agents that may be used to treat my cancer?
Open Clinical Trials
The following are studies looking at new treatments for people with TNBC.
- NCT03606967: Testing the Addition of an Individual Vaccine to Nab-Paclitaxel, Durvalumab and Tremelimumab and Chemotherapy in Patients With Triple Negative Breast Cancer. This study will look at how well the combination of chemotherapy, and when used with or without a vaccine made specifically for each patient.
- NCT04468061: Saci-IO TNBC: Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative TNBC. This early phase study is looking at how safe and effective Trodelvy with or without Pembrolizumab is in patients who have that has spread to other parts of the body.
- NCT04020575: Using a Type of Called CAR-T to Treat Triple-Negative Breast Cancer. This study will look at how safe and how well a type of treatment made from the patient's cancer works for treatment certain types of breast cancer.
- NCT03971409: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With IV or Unresectable, Recurrent (InCITe). This studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating TNBC that has recurred.
- NCT04837209. Radiation, and in Triple Negative Breast Cancer (NADiR). This research study is looking to see whether the combination of Dostarlimab and plus Radiation Therapy (RT) is safe and effective in participants with triple negative breast cancer.
- NCT05081492: Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and (Pembrolizumab) for Triple-Negative Breast Cancer. This study is looking at the safety, side effects, and best dose of a drug called CF33-hNIS-antiPDL1 in treating patients with triple negative breast cancer. CF33-hNIS-antiPDL1 is a virus that is designed to attack and kill cancer cells.
A number of other clinical trials for treating patients with TNBC can be found here.
Updated: 02/23/2024
Open Clinical Trials
The following studies are looking at treatment for people with advanced .
- NCT05252390: NUV-868 Alone and in Combination With PARP Inhibitors in Patients With Advanced .This study will test the safety and effectiveness of the experimental drug NUV-868 alone and combined with a in people with advanced . This study is open to people whose cancer stopped responding or progressed on PARP inhibitors.
- NCT02264678: Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents. This is a study of ceralasertib administered orally in combination with chemotherapy regimens and/or novel anticancer agents to patients with advanced cancer. The study is enrolling people with inherited mutations, including , , , , , and people with tumors that are HRD-positive.
- NCT04644068: Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (PETRA). This research is designed to learn whether treatment with a new , AZD5305, used alone or in combination with anti-cancer agents is safe, tolerable and has anti-cancer activity in patients with advanced . The study is open to people who have previously been treated with PARP inhibitors.
- NCT04267939: ATR Inhibitor Plus Study in Advanced and Ovarian Cancer. This study will look at how well people with advanced respond to treatment with the BAY1895344 in combination with the . This study is open to people with inherited mutations in , , and other genes. Contact the study coordinator for information about eligibility for people with mutations in other genes.
- NCT04657068: Treatment with ATR Inhibitor for Advanced or Solid Tumors. This study will look at how well a new oral known as an ATR inhibitor works on advanced or with mutations in genes that are linked to damage repair. This study is open to people who have an inherited or acquired or mutation or whose tumors are HRD-positive. This study is open to people whose cancer stopped responding or progressed on PARP inhibitors.
Updated: 02/01/2024
Peer Support
The following organizations offer peer support services for people with, or at high risk for breast cancer:
- FORCE peer support:
- Our Message Boards allow people to connect with others who share their situation. Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Our Peer Navigation Program will match you with a volunteer who shares your mutation and situation.
- Connect online with our Private Facebook Group.
- Join our virtual and in-person support meetings.
- Other organizations that offer breast cancer support:
Updated: 05/07/2024
Related Resources
The following resources may be helpful for people with .
- FORCE resources:
- Information: Breast cancer biomarkers, targeted and immunotherapies
- Information: Breast cancer
- XRAY category:
- Video: What's New in Breast Cancer Treatment?
- Video: What are Targeted Therapies and Immunotherapies?
- Video: and Question and Answer Panel
- Triple Negative Breast Cancer Foundation
Updated: 03/16/2022
Who covered this study?
Medscape
FDA Approves First Immunotherapy for Breast Cancer: Atezolizumab for Triple-Negative Disease
This article rates 5.0 out of 5 stars
Healio
FDA approves Tecentriq combination for PD-L1-positive, triple-negative breast cancer
This article rates 3.0 out of 5 stars
Reuters
Roche's Tecentriq notches win in breast cancer with U.S. approval
This article rates 3.0 out of 5 stars