The recent approval of Truqap (capivasertib) with hormone/endocrine therapy, Faslodex (fulvestrant), for a specific group of patients with HR-positive, HER2-negative breast cancer offers patients more treatment options, especially to match their specific mutational profiles, an expert said.
In November, the Food and Drug Administration (FDA) approved Truqap for patients with advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations who progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence within one year of finishing adjuvant therapy.
According to the National Cancer Institute, Truqap is a drug that blocks a protein called AKT, which can help prevent cancer cells from growing and may help destroy them. The drug is currently used to treat patients with metastatic HR-positive, HER2-negative breast cancer with abnormal PIK3CA, AKT1 or PTEN genes, but is being studied for the treatment of other cancers.
“In this particular case, what we’re trying to do — in what I call precision oncology — is to create drugs that will specifically attack genetic alterations that are only found in the cancer cell,” Dr. Ben Ho Park added during an interview with CURE®. “We don’t want to drug to attack our normal cells, we want to only attack the cancer cells.”
Park is the director of the Vanderbilt-Ingram Cancer Center and for the division of hematology and oncology, and is a professor of medicine at Vanderbilt University Medical Center.
He noted that the approval of Truqap plus Faslodex is important for this patient population because of its effectiveness, compared with other types of drugs.
“(Breast cancer and all cancers are) also always mutating, and that’s why they can develop (drug) resistance. So, then we had other drugs that were used in combination with these endocrine therapies that work better,” Park said. “And so, Truqap is kind of the latest in a long line of that thinking. So, it’s approved with an endocrine therapy for this population of hormone receptor-positive breast cancers that have become resistant to other types of drugs.”
Prior to the FDA’s approval of Truqap plus Faslodex, this particular patient population typically received endocrine therapy via an oral pill with CDK4/6 inhibitors, according to Park.
“The big real class of drugs that made a huge impact (are) what we now call CDK4/6 inhibitors. These are drugs like (Ibrance [Palbociclib]), (Kisqali [ribociclib]) and also (Verzenio [abemaciclib]),” Park said. “When these are combined with endocrine therapies, again, after progression, they have kind of a huge effect. And in fact, now we know if we use them upfront with endocrine therapy, you can get much better longevity in terms of disease control (in metastatic disease).”
In terms of unmet needs the Truqap-Faslodex combination addresses, Park noted that it provides patients with more treatment options than before.
Although there are available treatments that have also been FDA-approved, Park said that some patients in this respective population are unable to tolerate doses of these drugs. Now, patients who cannot tolerate other drugs have the ability to try the new Truqap-Faslodex combination.
“I think that that’s where having more options allows more patients to get the therapies that are matched to their kind of mutational profile of their cancer,” he said.
However, there are unmet needs that persist for this patient population. Park emphasized that there is still plenty of research that needs to be done, especially finding effective drugs for younger patients with HR-positive, HER2-negative breast cancer.
“So, in that sense, we have to do better. We have to do more research, we have to figure out how to cure all types of breast cancers, metastatic, early stage, hormone, receptor-positive, et cetera. I don’t think any of us are going to rest until that is done.”
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