Enhertu Breast Cancer Drug Results ‘Unheard of’ Survival Rates

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Patients had metastatic breast cancer that progressed despite rigorous rounds of chemotherapy. But treatment with a drug that targets cancer cells with laser-like precision has been surprisingly successful, slowing tumor growth and prolonging life to a degree rarely seen in advanced cancers.

The new study presented at the annual meeting of the American Society of Clinical Oncology and Published Sunday in the New England Journal of MedicineIt will change the way medicine is practiced, cancer experts said.

Breast cancer specialist Dr. Eric Winer, director of the Yale Cancer Center and president of ASCO, Dr. “This is a new standard of care,” Winer said. He added that it affects a large number of patients.

The trial focused on a particular mutant protein called HER2, which is a common villain in breast and other cancers. HER2-blocking drugs have been surprisingly effective in treating breast cancers that are almost entirely full of protein, transforming HER2-positive breast cancers from those with the worst prognosis to cancers where patients fare very well.

But director of breast medical oncology at the Cleveland Clinic, Dr. Halle Moore said HER2-positive cases only make up 15 percent to 20 percent of breast cancer patients. These drugs did not help patients who had only a few HER2 cells, a condition known as HER2-low. While only a small fraction of cancer cells have HER2, other mutations primarily made the cancer grow. And that was a problem because cancer cells were escaping chemotherapy treatments.

Sponsored by pharmaceutical companies Daiichi Sankyo and AstraZeneca, and Dr. The clinical trial led by Shanu Modi included 557 patients with metastatic breast cancer who had low HER2. Two-thirds took the experimental drug trastuzumab deruxtecan, sold as Enhertu; the rest is done standard chemotherapy.

In patients receiving trastuzumab deruxtecan, tumors stopped growing for approximately 10 months, compared to 5 months for those receiving standard chemotherapy. Patients with the experimental drug survived 23.9 months, compared to 16.8 months for those who received standard chemotherapy.

Enrolling some patients in the study, Dr. “It’s unheard of for chemotherapy trials in metastatic breast cancer to increase survival in patients by six months,” Moore said. Usually, he says, success in a clinical trial is a few extra weeks of life or no survival benefit other than improved quality of life.

The results were so impressive that they received a standing ovation when the researchers presented their data at the oncology conference in Chicago on Sunday.

Trastuzumab deruxtecan was already approved for patients with HER2-positive breast cancer, but few expected it to work because other drugs for this type of cancer had failed in HER2-low patients.

The drug consists of an antibody that looks for the HER2 protein on the surface of cells. The antibody binds to a chemotherapy drug. When trastuzumab finds a cell with HER2 on the deruxtecan surface, it enters the cell and the chemotherapy drug separates from the antibody and kills the cell.

However, Dr. Modi adds that the “unique and different” thing about trastuzumab deruxtecan is that the chemotherapy drug leaks through the cell membrane. From there it can move on to nearby cancer cells and kill them as well.

Like all chemotherapies, trastuzumab deruxtecan has side effects such as nausea, vomiting, blood disorders, and particularly lung injuries that killed three patients in the trials.

However, Dr. “If I were a metastatic breast cancer patient and I was going to take a drug that had the side effects of chemotherapy, I would choose this drug,” Winer said.

Doctors said they plan to try the treatment in breast cancer patients with metastatic HER2-low cancers.

A breast cancer specialist at the University of Pennsylvania Abramson Cancer Center, Dr. “We’re all going back now and looking at our patients,” said Susan Domchek. Even before the Food and Drug Administration approves trastuzumab deruxtecan for patients with low HER2, it says it will see if data from the new study will be enough to convince insurers to approve the drug. weeks.

Dr. Winer emphasized that trastuzumab deruxtecan is not a drug for early-stage breast cancer; however, it should be tested in that patient group. But that’s the next step, as is testing the drug in other cancers and expanding its strategy beyond HER2.

“This strategy is the real breakthrough,” he said, explaining that it will enable researchers to get close to molecular targets on tumor cells that are only rarely found.

Dr. “This is more than just this drug or even breast cancer,” Winer said. “The real advantage is that it allows us to take powerful treatments directly into cancer cells.”

One patient in the current study, 55-year-old Mary Smrekar of Medina, Ohio, said she felt temporarily relieved of certain death.

She was diagnosed with breast cancer in 2010 and underwent surgery, chemotherapy, and radiation therapy. His cancer is in remission.

“I thought I was free and clean,” he said.

But in 2019 the cancer came back. It spread to her hip. She had chemotherapy, but this time there was little improvement.

Two years ago, she went to trial on the Cleveland Clinic site. His cancer didn’t go away, but the tumors stopped growing.

“I am very happy that I have two more years,” said Ms. Smrekar. “My daughter is getting married next month. I didn’t think I’d be able to come to the wedding.”

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