Tecentriq (chemical name: atezolizumab), an immunotherapy medicine, combined with the chemotherapy Abraxane (chemical name: albumin-bound paclitaxel or nab-paclitaxel) offered better progression-free survival and overall survival compared to Abraxane alone for people diagnosed with locally advanced or metastatic triple-negative breast cancer who had not been treated yet for advanced-stage disease.
This is one of the first phase III studies to show an immunotherapy medicine offering benefits for treating breast cancer.
The research was presented on Oct. 20, 2018, at the 2018 European Society for Medical Oncology (ESMO) Congress and simultaneously published online by the New England Journal of Medicine.
- Read the ESMO media release and abstract of ”IMpassion130: Results from a global, randomised, double-blind, phase 3 study of atezolizumab (atezo) + nab-paclitaxel (nab-P) vs placebo + nab-P in treatment-naïve locally advanced or metastatic triple-negative breast cancer (mTNBC).”
- Read the New England Journal of Medicine abstract of “Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer.”
Locally advanced breast cancer is breast cancer that has spread to tissue near the breast, but not to parts of the body away from the breast. Metastatic breast cancer is cancer that has spread to parts of the body away from the breast, such as the bones or liver.
Triple-negative breast cancer is breast cancer that is:
Triple-negative breast cancers are usually more aggressive, harder to treat, and more likely to come back (recur) than cancers that are hormone-receptor-positive or HER2-positive. Triple-negative breast cancers don't usually respond to hormonal therapy medicines or the medicines that target the HER2 protein, such as Herceptin (chemical name: trastuzumab), Kadcyla (chemical name: T-DM1 or ado-trastuzumab emtansine), Nerlynx (chemical name: neratinib), Tykerb (chemical name: lapatinib), or Perjeta (chemical name: pertuzumab).
Progression-free survival is how long the people lived without the cancer growing. Overall survival is how long the people lived whether or not the cancer grew.
Right now, Tecentriq is approved by the U.S. Food and Drug Administration (FDA) to treat a type of bladder and urinary tract cancer called urothelial carcinoma and non-small cell lung cancer. Tecentriq currently is not approved to treat breast cancer.
Both Tecentriq and Abraxane are given intravenously as infusions.
How do immunotherapy medicines work?
Immunotherapy medicines work by helping your immune system work harder or smarter to attack cancer cells. Immunotherapy medicines use substances — either made naturally by your body or man-made in a lab — to boost the immune system to:
- stop or slow cancer cell growth
- stop cancer cells from spreading to other parts of the body
- be better at killing cancer cells
There are several types of immunotherapy medicines. Tecentriq is an immune checkpoint inhibitor immunotherapy medicine.
To start an immune system response to a foreign invader, the immune system has to be able to tell the difference between cells or substances that are “self” (part of you) versus “non-self” (not part of you and possibly harmful). Your body’s cells have proteins on their surfaces or inside them that help the immune system recognize them as “self.”
Some of these proteins that help your immune system recognize “self” cells are called immune checkpoints. Cancer cells sometimes find ways to use these immune checkpoint proteins as a shield to avoid being identified and attacked by the immune system’s T cells.
Immune checkpoint inhibitors target these immune checkpoint proteins and help the immune system recognize and attack cancer cells. Immune checkpoint inhibitors essentially take the brakes off the immune system by blocking checkpoint inhibitor proteins on cancer cells or on the T cells that respond to them.
Tecentriq is a PD-L1 checkpoint inhibitor.
PD-1 is a checkpoint protein on T cells. PD-L1 is another checkpoint protein found on many healthy cells in the body. When PD-1 binds to PD-L1, it stops T cells from killing a cell. Some cancer cells have a lot of PD-L1 on their surface, which stops T cells from killing these cancer cells. An immune checkpoint inhibitor medicine such as Tecentriq that stops PD-1 from binding to PD-L1 allows T cells to attack the cancer cells.
About the IMpassion130 study
This study was called the IMpassion130 study. The study included 902 people — 898 women and four men — who had been diagnosed with locally advanced or metastatic triple-negative breast cancer. None of the people had been treated for advanced-stage disease yet.
The characteristics of the people in the study:
- Ages ranged from 20 to 86.
- About 67% were white, about 17% were Asian, about 6% were black, and about 4% were Native American.
- About 90% had been diagnosed with metastatic disease.
The researchers randomly assigned the people to receive one of two treatments:
- 451 people were treated with Tecentriq plus Abraxane.
- 451 people were treated with placebo plus Abraxane.
The people continued treatment until the cancer grew or unacceptable side effects developed.
This analysis was done after 12.9 months of follow-up.
Overall, progression-free survival and overall survival were better in the group that was treated with Tecentriq plus Abraxane.
Progression-free survival was:
- 7.2 months for people treated with Tecentriq plus Abraxane
- 5.5 months for people treated with Abraxane alone
Overall survival was:
- 21.3 months for people treated with Tecentriq plus Abraxane
- 17.6 months for people treated with Abraxane alone
Because Tecentriq is a PD-L1 checkpoint inhibitor, the researchers specifically looked to see how well the medicine worked in the 369 people in the study diagnosed with breast cancer that was PD-L1 positive:
- 185 of these people were treated with Tecentriq plus Abraxane.
- 184 of these people were treated with Abraxane alone.
While progression-free survival was similar to the overall results, overall survival was a bit better for people diagnosed with PD-L1-positive disease treated with Tecentriq plus Abraxane.
For people diagnosed with PD-L1-positive disease, progression-free survival was:
- 7.5 months for people treated with Tecentriq plus Abraxane
- 5.0 months for people treated with Abraxane alone
For people diagnosed with PD-L1-positive disease, overall survival was:
- 25.0 months for people treated with Tecentriq plus Abraxane
- 15.5 months for people treated with Abraxane alone
“Atezolizumab in combination with nab-paclitaxel is the first targeted treatment to improve survival in metastatic triple-negative breast cancer,” said Peter Schmid, professor of cancer medicine at Queen Mary University of London and clinical director of the Breast Cancer Centre at St. Bartholomew's Hospital, who presented the research. “It is also the first immune therapy to improve outcomes in this cancer. Most of the survival benefit was in patients with PD-L1-positive tumors.”
What about side effects?
As with most cancer medicines, Tecentriq and Abraxane may cause side effects, some of them severe.
In the IMpassion130 study:
- 99.3% of people treated with Tecentriq and Abraxane had side effects
- 97.9% of the people treated with Abraxane had side effects
The most common side effects in both treatment groups were:
- hair loss: 56.4% in the Tecentriq-Abraxane group and 57.5% in the Abraxane-alone group
- nausea: 46% in the Tecentriq-Abraxane group and 38.1% in the Abraxane-alone group
- cough: 24.8% in the Tecentriq-Abraxane group and 18.9% in the Abraxane-alone group
- peripheral neuropathy: 21.7% in the Tecentriq-Abraxane group and 22.1% in the Abraxane-alone group
- neutropenia (low white blood cell counts): 20.8% in the Tecentriq-Abraxane group and 15.3% in the Abraxane-alone group
- fever: 18.8% in the Tecentriq-Abraxane group and 10.7% in the Abraxane-alone group
- hypothyroidism (underactive thyroid): 13.7% in the Tecentriq-Abraxane group and 3.4% in the Abraxane-alone group
Severe side effects happened in:
- 48.7% of people treated with Tecentriq and Abraxane
- 42.2% of people treated with Abraxane alone
The most common severe side effects were low white blood cell counts, peripheral neuropathy, fatigue, and anemia. Rates of severe peripheral neuropathy were about twice as high in the Tecentriq-Abraxane group (5.5%) compared to the Abraxane-alone group (2.7%).
Because immunotherapy medicines are relatively new, the researchers also noted side effects of special interest that potentially may have an immunity-related cause. Serious side effects of special interest happened almost twice as often in people treated with Tecentriq and Abraxane (7.5%) compared to people treated with Abraxane alone (4.3%). The researchers pointed out that hypothyroidism was more than four times more common in people treated with Tecentriq and Abraxane compared to people treated with Abraxane alone.
Overall, 15.9% of people in Tecentriq-Abraxane group stopped treatment because of side effects and 8.2% of people in the Abraxane-alone group stopped treatment because of side effects.
The researchers attributed three of six deaths in the Tecentriq-Abraxane group to the treatment regimen and one of three deaths in the Abraxane-alone group to the treatment regimen.
What do these results mean for you?
While the results of the IMpassion130 study are very exciting and promising, it’s important to know that the follow-up for the study was only about a year. Longer follow-up time will offer more information on how long the cancers respond to Tecentriq, as well as whether it’s possible for people to ever stop treatment with Tecentriq.
Also, several doctors who were not involved with the study said that the side effects of Tecentriq need to be looked at closely, including Jennifer Litton, of the MD Anderson Cancer Center, and Larry Norton, of Memorial Sloan Kettering Cancer Center. Norton is a member of the Breastcancer.org Professional Advisory Board.
It’s expected that Roche, the company that makes Tecentriq, will ask the FDA to approve a breast cancer indication for the medicine.
It’s also important to know that Tecentriq costs about $12,500 per month. Because Tecentriq is not yet FDA approved to treat breast cancer, it’s unclear how many insurance providers will cover the cost for breast cancer treatment.
If you’ve been diagnosed with locally advanced or metastatic triple-negative breast cancer and are deciding on treatments for the advanced-stage disease, you may want to talk to your doctor about this study. You may want to ask if it’s possible to do PD-L1 testing on the cancer to see if you might benefit from a PD-L1 checkpoint inhibitor such as Tecentriq. You also may want to ask about other trials looking at Tecentriq and other immune checkpoint inhibitors and whether any of them might be a good fit for your unique situation.
For more information on immunotherapy medicines and how they work and their possible side effects, visit the Breastcancer.org Immunotherapy section.
To discuss Tecentriq and other immunotherapy medicines with others, join the Breastcancer.org Discussion Board forum Immunotherapy - Before, During, and After.
Editor’s Note: On March 8, 2019, the FDA approved Tecentriq in combination with Abraxane as a first treatment for unresectable locally advanced or metastatic triple-negative, PD-L1-positive breast cancer.
Written by: Jamie DePolo, senior editor
Reviewed by: Brian Wojciechowski, M.D., medical adviser