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Roche trumpets APHINITY data, but did it hit the mark?

Results raise questions about benefit of combining Herceptin with Perjeta


After months of anticipation, Roche put the results of its trial of Herceptin plus Perjeta in neoadjuvant breast cancer therapy on show at ASCO, but not everyone was impressed with the findings.

On the plus side, adding Perjeta (pertuzumab) to treatment with Herceptin (trastuzumab) and chemotherapy reduced the risk of breast cancer recurrence by 19% compared to Herceptin alone after three years in post-surgery HER2-positive breast cancer patients, which just about reached statistical significance.

However the disease-free survival numbers failed to impress, with less than 1% difference between the groups at that time point. All told, 94.1% of women on Herceptin and Perjeta had not developed the invasive disease at three years, compared to 93.2% who were treated with Herceptin alone.

The data has prompted suggestions that Roche could find it tough to convince healthcare payers of the value of giving the two pricey drugs together, particularly as cheaper biosimilar versions of Herceptin have now been filed in Europe and the US. One year of adjuvant therapy with Perjeta plus Herceptin and chemotherapy can cost upwards of $150,000, roughly twice the cost of Herceptin alone.

A large chunk of Perjeta's $5bn sales forecast has been attributed to adjuvant use alongside Herceptin and chemo, according to EP Vantage.

Undeterred, Roche is pressing ahead with regulatory filings based on APHINITY, with chief medical officer Sandra Horning saying the Perjeta-based regimen "improved upon the high bar set by Herceptin in people with HER2-positive early breast cancer".

Roche is planning to continue to follow up patients for up to 10 years, to see if the combination continues to improve on Herceptin alone. Despite advancements in the treatment of HER2-positive breast cancer, one in four people treated with Herceptin and chemotherapy will eventually see their cancer return in the long-term, it says.

The results of the APHINITY trial could present an opportunity to US biotech Puma, which won a positive recommendation from an FDA advisory committee for its neratinib candidate in post-surgery patients last month. In trials, neratinib achieved a 33% reduction in the risk that patients would go onto develop recurrent disease within two years, which equated to a more than 2% difference in disease-free survival.

The APHINITY data has been published in the New England Journal of Medicine along with being presented at ASCO in Chicago.

In an editorial accompanying the study, Kathy Miller of the University of Nebraska writes: “To be clear, APHINITY is a positive trial."

"To be equally clear, as compared to the results of pertuzumab in the context of metastatic disease and neoadjuvant therapy, APHINITY is a disappointment."

Article by
Phil Taylor

5th June 2017

From: Research



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