Oncologists See Promise in Neratinib, New Oral HER2-Positive Drug

Marcia Frellick

July 12, 2017

Half of oncologists (49%) surveyed by Medscape see the coming launch of neratinib (Nerlynx, Puma Biotechnology) as an important or very important development in treating HER2-positive breast cancer, which tends to grow and spread faster than other breast cancers.

Thirty percent said the new choice was moderately important; 18% answered slightly important; and 3% said it was not at all important.

The US Food and Drug Administration is expected to make a decision on whether to approve the drug by July 21. Medscape recently invited 93 practicing oncologists via email to weigh in on the potential for the drug.

One respondent who rated the drug as very important wrote, "We need more treatments for all cancers but this one is very exciting."

About a third (35%) of the oncologists said they were ready to investigate the potential for the drug with some of their patients but wanted to evaluate the efficacy compared with the other agents before they fully accept neratinib. Many (27%) are convinced and are ready to prescribe it as soon as it is available.

Of all the oncologists surveyed, 88% indicated that they would use neratinib to treat their HER2-positive breast cancer patients. Among all the patients, 21% would receive neratinib. For those treated with the new product, 59% will be with a single agent. One in three patients (35%) would receive neratinib plus pertuzumab, and 6% would receive neratinib plus another agent.

 

 

Already there is much awareness of neratinib. Almost a third (31%) of the oncologists surveyed already had an understanding of the clinical trial data on the drug; 25% reported knowing the basic information; and 27% were very familiar with the drug. Only 4% said they had never heard of it.

After that initial question, oncologists were told the following about the drug:

"Neratinib is a tyrosine kinase inhibitor (TKI) indicated as an oral extended adjuvant therapy for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin).

"In the Phase II ExteNET study, treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo. The 2-year invasive disease free survival (DFS) rate for the neratinib arm was 93.9% and the 2-year DFS rate for the placebo arm was 91.6%.

"For the pre-defined subgroup of patients with hormone receptor positive disease, the results of the trial demonstrated that treatment with neratinib resulted in a 49% reduction of risk of invasive disease recurrence or death versus placebo.

"For the patients with hormone receptor positive disease, the 2-year DFS rate for the neratinib arm was 95.4% and the 2-year DFS rate for the placebo arm was 91.2%."

Adverse Events

The most frequent adverse event experienced by the patients treated with neratinib was diarrhea – about 40% experienced grade 3 or higher. Patients in the ExteNET trial did not receive antidiarrheal agents.

Not surprisingly, side effects were the number one barrier the oncologists listed to prescribing (59%), followed by problems with insurance coverage and reimbursement, at 53%.

One respondent who rated the drug as "slightly important" said, "It's a positive trial, but not without diarrhea, which can be problematic for some patients."

Still, according to the survey, if neratinib becomes available, pertuzumab and lapatinib are expected to be prescribed to fewer patients, by 5% and 2.5%, respectively.

The biggest reason for prescribing neratinib over other agents among oncologists who would reduce their use of other agents was preferred mode of administration (45%), followed by better efficacy, at 43%.

To participate, oncologists had to be US residents and had to have treated at least five patients with HER2-positive breast cancer per month. Those who completed the survey, taken from June 14 to June 28, received a $50 gift card.

In this survey, 76% of the respondents were men, and 51% worked in office-based, single-specialty practices. Nearly 60% had been in practice at least 16 years.

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