Physician Views: How will oncologists use Eli Lilly's Verzenio?

The FDA has approved a third CDK 4/6 inhibitor in Eli Lilly's Verzenio (abemaciclib); specifically in combination with Faslodex (fulvestrant) for the treatment of HR+/HER2- metastatic breast cancer in patients who have progressed following endocrine therapy. Verzenio is also the only drug in class to be approved for monotherapy use; in third-line HR+/HER2- breast cancer patients who have previously been treated with endocrine therapy and chemotherapy – ViewPoints: Newest breast cancer market is now a triple-play.

We are snap-polling US oncologists to ascertain how Verzenio may be used in relation to the already marketed CDK 4/6 agents Ibrance (palbociclib) and Kisqali (ribociclib), which are marketed by Pfizer and Novartis, respectively. Specifically we are asking them...

The FDA has approved a third CDK 4/6 inhibitor for the treatment of HR+/HER2- breast cancer. Eli Lilly's Verzenio can be used with Faslodex to treat patients whose disease has progressed following endocrine therapy. This combination was shown to increase median progression-free survival (PFS) to 16.4 months versus 9.3 months for Faslodex monotherapy. Taking into account the availability of Ibrance and Kisqali as other approved CDK 4/6 inhibitors – as both second and also first-line therapies – how clinically compelling is availability of Verzenio based on its PFS data?

Not compelling

Slightly compelling

Moderately compelling

Very compelling

Extremely compelling

Verzenio is also the first drug in class to be approved as a monotherapy – as a third-line treatment for metastasised HR+/HER2- breast cancer after endocrine therapy and chemotherapy. How would you characterise the commercial opportunity for Verzenio in this particular setting?

None

Minimal

Moderate

Significant

Very significant

According to Verzenio's label, diarrhoea occurred in 86% of patients receiving the drug with Faslodex in the MONARCH 2 study and 90% of patients receiving Verzenio alone in the MONARCH 1 study. Grade 3 diarrhoea occurred in 13% of patients receiving Verzenio plus Faslodex and in 20% of patients receiving Verzenio alone. Diarrhoea incidence was greatest during the first month of Verzenio dosing and median time to onset of the first event was 6 days, and the median duration of diarrhoea for Grades 2 and 3 were 9 days and 6 days, respectively. Twenty-two percent of patients with diarrhoea required a dose omission and 22% required a dose reduction.

Taking into account the respective incidence rates of diarrhoea for Ibrance and Kisqali, to what extent do you anticipate this particular side effect will limit adoption of Verzenio in a real-world setting?

No impact

Minimal impact

Moderate impact

Significant impact

Very significant impact

Verzenio is the only CDK4/6 inhibitor that has a warning on its label for venous thromboembolism ("monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate."). To what extent do you think this could impede utilisation?

No impact

Minimal impact

Moderate impact

Significant impact

Very significant impact

Ibrance is the longest-approved CDK4/6 inhibitor by some margin (approved by FDA in February 2015). Based on you experience with Ibrance, can you describe your level of clinically-led motivation to use an alternative drug in this class?

No motivation

Minimal motivation

Moderate motivation

Significant motivation

Very significant motivation

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

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