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Roche's Perjeta should be 'new standard' in breast cancer

Could improve survival when added to therapy with Herceptin and docetaxel

Roche's Perjeta pertuzumab 

Adding Roche's Perjeta to therapy with Herceptin and docetaxel has a dramatic impact on survival in patients with HER2-positive metastatic breast cancer, according to new trial data.

Giving Perjeta (pertuzumab) alongside Roche's breast cancer blockbuster Herceptin (trastuzumab) plus docetaxel chemotherapy extended survival by more than 15 months compared to Herceptin and docetaxel alone in the 800-patient CLEOPATRA trial.

The size of the benefit, with patients on Perjeta living a median of 56.5 months versus 40.8 months on the comparator regimen, means that pertuzumab-containing regimen is "the new standard of care" in first-line treatment of HER2-positive metastatic breast cancer," according to lead investigator Professor Sandra Swain of the Washington Cancer Institute.

Describing the results as "phenomenal" and "unprecedented" Swain also noted that progression-free survival was also extended by more than six months with the combination therapy.

The CLEOPATRA data underpinned the approval of Perjeta as an add-on therapy to Herceptin last year, after an interim analysis in 2012 revealed an improvement in overall survival.

Dr Giuseppe Curigliano, Director of the Division of Experimental Therapeutics in Milan, Italy, said that the study "changes clinical practice", adding that "in the future, in any country of the world, when you have a patient with metastatic breast cancer that is HER2 positive, the proposal for treatment should include dual targeting with pertuzumab and trastuzumab plus chemotherapy."

Curigliano added that in addition to this study, Roche is also conducting the APHINITY trial comparing pertuzumab and trastuzumab versus trastuzumab alone in the neo-adjuvant setting - before surgery - which could lead to its use in earlier-stage breast cancer.

Since it first reached the market two years ago the drug has grown rapidly to become one of Roche's largest cancer products, bringing in 388m Swiss francs ($407m) in the first six months of this year, almost three times its turnover in the same period of 2013.

While that tally is still behind the 3bn francs racked up by Herceptin in the same period, the new data suggest Roche's HER2 breast cancer franchise - which also features fast-growing antibody-drug conjugate Kadcyla (trastuzumab emtansine) has plenty in the tank even through Herceptin is starting to lose patent protection in some markets, including this year in the EU.

Much will, however, depend on whether giving Perjeta alongside Herceptin is affordable for cash-strapped healthcare systems, with the price of the combination coming in at around £115,000 ($187,000) per year.

In the UK, the National Institute for Health and Care Excellence (NICE) has rejected both Perjeta and Kadcyla in draft guidances, on the grounds that the data does not support the high costs of the drugs. With the latest CLEOPATRA data in hand the argument for the cost-effectiveness of Perjeta is getting stronger.

Article by
Phil Taylor

29th September 2014

From: Research

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