2015 Breast Cancer Pulse #2
2015 Breast Cancer Pulse #2
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This 5-question pulse of 24 oncologists practicing in the United States focuses on the usage of HER2-targeted agents for the treatment of breast cancer.
Publisher: Biomedtracker
- Description
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Overview
This 5-question pulse of 24 oncologists practicing in the United States focuses on the usage of HER2-targeted agents for the treatment of breast cancer. Although Herceptin (trastuzumab) remains the mainstay of treatment in all settings for patients with HER2-positive disease, Genentech/Roche is pushing forward with clinical trials for Perjeta (in combination with Herceptin) and Kadcyla as Herceptin’s patent expiration dates loom closer. Roche hopes to position Kadcyla as a less-toxic alternative to Herceptin + chemotherapy in the first-line metastatic setting (MARIANNE trial) and Perjeta as an add-on to Herceptin in patients with early breast cancer.
Meanwhile, Puma Biotechnology (PBYI) hopes to gain approval for its irreversible EGFR/HER2 inhibitor neratinib, which the sponsor licensed from Wyeth/Pfizer. This agent reduces disease recurrence rate for some early-stage breast cancer patients in the post- Herceptin adjuvant setting. An approval for Puma in this setting will allow the company to gain a foothold in a market that GSK sought to break into with Tykerb (lapatinib), another oral EGFR/HER2 TKI that is used primarily in the metastatic setting.
The following drugs are discussed in this pulse:
- Neratinib (PBYI)
- Herceptin (trastuzumab, Roche)
- Perjeta (pertuzumab, Roche)
- Kadcyla (trastuzumab-DM1, Roche)
- Tykerb (lapatinib, GSK)
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Question1: In the last three months, how many patients did you see in the following subgroups? Please include all patients in each subgroup, including patients not actively receiving treatment (i.e. in follow-up after treatment).
Question 2: Please describe your current usage of HER2-targeted therapies. In the last 3 months, how many of your patients received the following agents? Please consider all HER2-positive patients in all treatment settings.
Question 3: Please describe your usage of Perjeta-containing regimens in the last 3 months, by line of treatment. Please provide this answer as a percentage of total Perjeta prescriptions. Only enter a percentage for the “I did not use Perjeta” selection if you did not prescribe Perjeta at all in the last 3 months.
Question 4: The irreversible EGFR/HER2 inhibitor neratinib is being tested in a Phase 3 trial in Stage 2/3, HER2+ BC: 1 year neratinib or placebo PO QD following standard adjuvant treatment including 1 year Herceptin. Invasive DFS was 93.9% vs 91.6% for neratinib & pbo. TEAEs included 40% Gr3 diarrhea; in another trial, loperamide prophylaxis reduced diarrhea to 5%.
Question 5: Assume neratinib is approved in 2017 with the profile described previously: invasive DFS was 93.9% vs 91.6% for neratinib & pbo. TEAEs included 40% Gr3 diarrhea; in another trial, loperamide prophylaxis reduced diarrhea to 5%. Based on these results, how will you prescribe neratinib to early breast cancer patients in the trial population (Stage 2–3c, HER2+, following adjuvant Herceptin)?
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