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Studies Show Conflicting Results With Tecentriq and Chemotherapy for Metastatic Triple-Negative Breast Cancer

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When treating unresectable locally advanced or metastatic triple-negative breast cancer for the first time, adding the immunotherapy medicine Tecentriq (chemical name: atezolizumab) to Taxol (chemical name: paclitaxel) did not improve survival, while adding Tecentriq to Abraxane (chemical name: albumin-bound or nab-paclitaxel) did improve survival, according to results from two studies.

Both studies were presented on Sept. 19, 2020, at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Triple-negative breast cancer is cancer that has no receptors for the hormones estrogen and progesterone, as well as no receptors for the HER2 protein. This limits the medicines that can be used to treat the 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.

Unresectable means the cancer can’t be removed with surgery.

About Tecentriq

Tecentriq is an immune checkpoint inhibitor.

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) vs. “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.

Immune system cells called T cells roam throughout the body looking for signs of disease or infection. When T cells meet another cell, they analyze certain proteins on the cell’s surface, which helps the T cell identify the cell. If the surface proteins signal that the cell is normal and healthy, the T cell leaves it alone. If the surface proteins suggest the cell is cancerous or unhealthy in another way, the T cell starts an attack against it.

Immune checkpoint inhibitors target 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.

PD-1 is a type of checkpoint protein found 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 that stops PD-1 from binding to PD-L1 allows T cells to attack the cancer cells.

Tecentriq is a PD-L1 inhibitor approved by the U.S. Food and Drug Administration (FDA) to be used in combination with Abraxane to treat unresectable locally advanced or metastatic triple-negative, PD-L1-positive breast cancer.

Tecentriq is given intravenously, which means the medicine is delivered directly into your bloodstream through an IV or a port.

The difference between Abraxane and Taxol

Both Abraxane and Taxol are taxane chemotherapy medicines that work by interfering with the cancer cells’ ability to divide.

Taxol uses a solvent to dissolve the paclitaxel so it can enter the bloodstream. This solvent can make Taxol hard to tolerate, so most people are pretreated with a steroid to minimize any reactions to the solvent.

Instead of a solvent, the paclitaxel in Abraxane is wrapped in albumin, a protein, so people do not need to be pretreated with a steroid when being treated with Abraxane.

Both Taxol and Abraxane also are given intravenously.

About the IMpassion130 study

The IMpassion130 study included 902 people — 898 women and 4 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 people enrolled in the study between June 2015 and May 2017.

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, an infusion that was just like Tecentriq, but contained no medicine, plus Abraxane

The people continued treatment until the cancer grew or unacceptable side effects developed.

As of April 2020, 6% of the people receiving Tecentriq and Abraxane and 2% of people receiving Abraxane alone were still being treated; 666 people (73.8%) had died.

For people diagnosed with breast cancer that was PD-L1 positive, overall survival was:

  • 25.4 months for people treated with Tecentriq and Abraxane
  • 17.9 months for people treated with Abraxane alone

This difference was not statistically significant, which means that it could have been due to chance and not because of a difference in treatment.

Overall survival is how long a person lives, whether or not the cancer grows.

“Although overall data in the overall population remained not statistically significant and precluded formal testing, the results are of clinical significance, and we cannot deny the overall survival advantage in the long term, reinforcing the role of this combination in the first-line setting,” said Giampaolo Bianchini, M.D., of the IRCCS Ospedale San Raffaele, Milan, Italy, in a statement.

About the IMpassion131 study

The IMpassion131 study had a similar design to the IMpassion130 study, but used Taxol instead of Abraxane for chemotherapy. The researchers wanted to know if adding Tecentriq to Taxol would improve progression-free survival and overall survival.

Progression-free survival is how long a person lives without the cancer growing.

The IMpassion131 study included 651 people diagnosed with unresectable locally advanced or metastatic triple-negative breast cancer. None of the people had been treated for advanced-stage disease yet.

The researchers randomly assigned the people to receive one of two treatments:

  • 220 people were treated with Tecentriq and Taxol
  • 431 people were treated with placebo, an infusion that looked just like Tecentriq, but contained no medicine, and Taxol

The people continued treatment until the cancer grew or unacceptable side effects developed.

There were 292 people (45%) in the study diagnosed with cancer that was PD-L1 positive.

For people diagnosed with PD-L1-positive breast cancer, progression-free survival was:

  • 6.0 months for people treated with Tecentriq and Taxol
  • 5.7 months for people treated with Taxol alone

This slight difference was not statistically significant, which means that it could have been due to chance and not because of the difference in treatment.

Looking at all the people in the study — both PD-L1 positive and PD-L1 negative — progression-free survival was:

  • 5.7 months for people treated with Tecentriq and Taxol
  • 5.6 months for people treated with Taxol alone

This very small difference also was not statistically significant.

In people diagnosed with PD-L1-positive breast cancer, estimated 2-year overall survival rates were:

  • 49% for people treated with Tecentriq and Taxol
  • 51% for people treated with Taxol alone

For all the people in the study, estimated 2-year overall survival rates were:

  • 42% for people treated with Tecentriq and Taxol
  • 45% for people treated with Taxol alone

These results suggest that more people treated with Taxol alone, compared to Taxol and Tecentriq, would be alive after 2 years.

“The primary objective of this study was not met,” said David Miles, M.D., of the Mount Vernon Cancer Center in Northwood, England, during his presentation. “The addition of atezolizumab to paclitaxel didn't improve progression-free survival with PD-L1-positive disease. There was no evidence of an overall survival effect. The safety of the chemotherapy and the atezolizumab was exactly as expected from our previous studies with the individual drugs.

“Clearly, this result throws open questions as to why we see a contrast in this study with paclitaxel versus IMpassion130 with nab-paclitaxel,” he added. “I'm sure that's going to be the subject of much more exploration and an awful lot of discussion in the future.”

FDA issues warning on Tecentriq-Taxol combination

On Sept. 8, 2020, the FDA issued a warning, based on the results of the IMpassion131 study, telling doctors and researchers that the combination of Tecentriq and Taxol should not be used to treat previously untreated unresectable locally advanced or metastatic triple-negative breast cancer because it is not effective.

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

Why the difference in results?

At the ESMO 2020 conference, Lisa Carey, M.D., of the Lineberger Comprehensive Cancer Center at the University of North Carolina-Chapel Hill, was invited to explain the differing results of the two studies.

She discussed three possible reasons:

  • the difference in chemotherapy medicines
  • possible differences in the people in the study
  • chance

“We routinely give steroids to the patient population [treated with Taxol] to minimize the risk of hypersensitivity,” Michael Method, M.D., oncologist and senior medical adviser and global lead for adjuvant breast cancer treatment research at Lilly Oncology, told Breastcancer.org.

“The question that arose … is, by giving steroids, are you inhibiting … or somehow influencing the impact that an immunotherapy would have on the treatments at that time? I don’t have the answer, but I think there are several potential answers [for the difference in results].”

So, the bottom line is that researchers aren’t sure yet why the two studies had different results, but they are investigating it.

What this means for you

If you’ve been diagnosed with unresectable 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 PD-L1 testing on the cancer and whether Tecentriq is right for your unique situation.

If the cancer is PD-L1-positive, it's likely that your doctor will recommend you be treated with a combination of Tecentriq and Abraxane. Still, if your doctor suggests pairing Tecentriq with Taxol, you should bring up the results of the IMpassion131 study and the FDA warning.

For more information on immunotherapy medicines, including how they work and their possible side effects, visit the Breastcancer.org Immunotherapy page.

To discuss Tecentriq and other immunotherapy medicines with others, join the Breastcancer.org Discussion Board forum Immunotherapy - Before, During, and After.

Listen to the Podcast episode, Does Chemotherapy Choice Affect How Well Tecentriq Works Against Breast Cancer?, with Leisha Emens, M.D., Ph.D.

Written by: Jamie DePolo, senior editor


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