Regulatory Affairs

European Commission approves Perjeta and Herceptin combo

Published 04 June 2018

The European Commission (EC) has approved Roche’s Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery treatment of adults with HER2-positive early breast cancer (eBC) at high risk of recurrence.

High risk of recurrence is defined as lymph node-positive or hormone receptor-negative disease. The Perjeta-based regimen should be administered for a total of one year (up to 18 cycles) as part of a complete regimen for eBC and regardless of the timing of surgery.

HER2-positive breast cancer affects almost 100,000 women in Europe each year. The majority of these cases are diagnosed at an early stage, when the aim of treatment is cure.

While significant advances have been made in treating HER2-positive eBC, around one in four patients treated with Herceptin and chemotherapy will eventually see their disease return in the long-term.

It is estimated that two out of three cases of HER2-positive advanced breast cancer (aBC) are a result of recurrence, as opposed to aBC being the initial diagnosis.

There is no cure for breast cancer that recurs and reaches an advanced stage; in these cases, treatment is aimed at prolonging life for as long as possible.

Roche chief medical officer and global product development head Sandra Horning said: “Despite advances in the treatment of HER2-positive early breast cancer, many people still have a recurrence and progress to an incurable stage. In the early breast cancer setting, where the ultimate goal is cure, it is critical that we continue building on existing therapies.

“Today’s approval is great news, as we believe the Perjeta-based regimen has the potential to make a significant impact on the lives of people with HER2-positive early breast cancer who are at high risk of recurrence.

“We are committed to working with EU member states to ensure the Perjeta-based regimen is available to eligible patients as soon as possible.”

Memorial Hospital Memorial Sloan Kettering Cancer Center physician-in-chief José Baselga said: “Some patients with early HER2-positive breast cancer are more likely to relapse than others, despite available treatments.

“Perjeta builds on the efficacy we have already seen with Herceptin and provides a clinically meaningful reduction in the risk of the breast cancer returning or death, for patients at high risk of recurrence.

“The only setting where we can potentially cure HER2-positive breast cancer is at the early stage, so the availability of new treatment options is great news for patients.”

The EC approval is based on results from a large phase III study (APHINITY), involving over 4,800 people with HER2-positive eBC8, which showed that the Perjeta-based regimen significantly reduced the risk of invasive breast cancer recurrence or death (invasive disease-free survival, iDFS) compared to Herceptin and chemotherapy alone in the overall study population.

At the time of primary analysis, the Perjeta-based regimen showed the greatest benefit in certain patients who are at high risk of recurrence:

For patients with lymph node-positive disease, the risk of recurrence or death was reduced by 23% with the Perjeta-based regimen (HR=0.77; 95% CI 0.62-0.96, p=0.019).

Among patients with hormone receptor-negative disease, the Perjeta-based regimen reduced the risk of recurrence or death by 24% (HR=0.76; 95% CI 0.56-1.04, p=0.085).

The safety profile of the Perjeta-based regimen was consistent with that seen in previous studies, with a low incidence of cardiac events and no new safety signals.

In the eBC setting, treatment may be given before surgery (neoadjuvant treatment) to shrink tumours and after surgery (adjuvant treatment) to help prevent the cancer from returning.

The Perjeta-based regimen is already licensed in the EU, US and many other countries as a neoadjuvant treatment.

The adjuvant approval means that eligible patients with HER2-positive eBC in Europe should be treated with the Perjeta-based regimen for a total of one year as part of a complete regimen for eBC, regardless of the timing of surgery.

The Perjeta-based regimen is already approved in the US and several other countries for adjuvant treatment of HER2-positive eBC at high risk of recurrence.

The combination has also been previously approved for the treatment of people with advanced HER2-positive breast cancer, where it has been shown to significantly extend survival compared to Herceptin and chemotherapy alone.

On 30 April, the EC also approved the use of Perjeta with a subcutaneous (SC) formulation of Herceptin as an alternative to the previously approved co-administration of Perjeta with Herceptin intravenous (IV) formulation.

The Herceptin SC formulation allows Herceptin to be delivered to patients in two to five minutes via an injection under the skin, compared to 30 to 90 minutes required for the original IV formulation.

Perjeta works in combination with Herceptin to provide a more comprehensive, dual blockade of the HER2 receptor, thus preventing tumour cell growth and survival.

Source: Company Press Release.