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Disease Analysis: HR+/HER2- Breast Cancer

Disease Analysis: HR+/HER2- Breast Cancer

  • February 2020
  • 93 pages
  • ID: 5868669
  • Format: PDF
  • Pharma Intelligence

Summary

Table of Contents

Latest key takeaways

The analyst estimates that in 2018 there were 2.1 million incident cases and 8.6 million five-year prevalent cases of breast cancer worldwide. By 2027, incident and prevalent cases of breast cancer are expected to increase to 2.3 million and 9.3 million cases, respectively.

CDK4/6 inhibitors remain the standard treatment for advanced and metastatic HR+/HER2- patients. The analyst expects their uptake to increase significantly over the forecast period as all three are projected to receive strategic label expansions into the adjuvant treatment setting for early-stage HR+/HER2- breast cancer patients.

The PARP inhibitors have become the standard option for gBRCAm+ breast cancer patients. Despite their efficacy in this population, their overall commercial potential will remain limited by their positioning in this niche segment.

Faslodex remains a key therapy across patient segments. Guideline recommendation for use at first-line and subsequent lines of therapy, indication for use in combination with the CDK4/6 inhibitors, as well as expansion as part of a combination with Piqray highlight its broad utility.

Piqray is the first PI3K inhibitor approved for use in breast cancer. The overall potential of Piqray will be somewhat limited by its side-effect profile that includes high rates of neutropenia, nausea, hyperglycemia, and diarrhea.

Afinitor remains a standard option for patients that progress on prior endocrine therapy, and is typically used post-CDK4/6 inhibitor treatment. However, generic versions of the drug will continue to take market share over the forecast period.

Halaven’s overall potential will remain limited in this space as it is relegated to use as a salvage therapy in heavily pretreated patients and faces generic competition in all markets, beginning in 2023 in the US and 2024 in the EU and Japan.

The utility of biomarker testing and its impact on subsequent treatment decisions in advanced and heavily pretreated patients is increasing and will continue to expand into earlier lines of therapy. Existing therapies like the PARP inhibitors and Piqray highlight this trend, and late-phase assets like PARP inhibitor veliparib and pan-Akt inhibitor ipatasertib will continue it in later portions of the forecast.

All late-phase therapies in development for HR+/HER2- breast cancer are targeting advanced and heavily pretreated patients; potentially increasing competition and causing prescribing in advanced settings to become highly segmented.

Generic and biosimilar versions of key branded therapies will slow growth of the HR+/HER2- breast cancer market. The largest generic impact will come from palbociclib generics, given that Ibrance is a standard therapy in treating HR+/HER2- breast cancer and physicians are expected to switch to cheaper generic versions of the molecule when they are expected to launch in 2023 in the US.

A relatively high proportion of trials for breast cancer have been in Phase II (45.5%), compared to other indications. The US, France, and Spain have seen the greatest number of breast cancer trials, globally. Within Asia, China has the top spot. Clinical trial activity in the breast cancer space is dominated by completed trials. Roche has the highest number of completed clinical trials for breast cancer, with 435 trials.

The overall likelihood of approval of a Phase I breast cancer asset is 9.2%, and the average probability a drug advances from Phase III is 59.2%. Breast cancer drugs, on average, take 9.9 years from Phase I to approval, compared to 9.3 years in the overall oncology space.

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