Roche closes on EU approval for Tecentriq in breast cancer

Roche is heading for EU approval of Tecentriq as first-line therapy for triple-negative breast cancer (TNBC), ahead of its checkpoint inhibitor rivals.

The Committee for Medicinal Products for Human Use (CHMP) backed the use of the PD-L1 inhibitor in patients with locally-advanced or metastatic TNBC that cannot be treated with surgery and who haven’t previously received chemotherapy. The EMA typically approves drugs a few weeks after a positive CHMP opinion.

The new indication – which was approved by the FDA in March – is seen as a big commercial opportunity for Tecentriq (atezolizumab) as it is the first checkpoint inhibitor to be cleared for use in any form of breast cancer.

It not only represents a sizeable patient population, affecting around 15% of the 2 million women diagnosed with breast cancer each year worldwide, but also has no competition yet from other cancer immunotherapies such as Merck & Co/MSD’s market leading Keytruda and Bristol-Myers Squibb’s Opdivo.

The CHMP positive opinion applies to women whose tumours express PD-L1 but lack receptors for oestrogen, progesterone or HER2 – effectively preventing treatment with hormonal therapies or anti-HER2 drugs like Roche’s Herceptin.

TNBC is a particularly aggressive form of breast cancer with treatment options that until recently were mostly limited to surgery, radiotherapy and chemotherapy, depending on the stage of the disease. AstraZeneca’s Lynparza and Pfizer’s Lynparza can be used in TNBC, but only in patients whose cancers express the BRCA biomarker.

Five-year survival rates tend to be much lower with TNBC than with other breast cancer types, so Tecentriq is a welcome new addition to the treatment options for this form of the disease.

Analysts have also suggested that Roche has a lead of at least a year over other checkpoint inhibitors in TNBC, with Keytruda considered to be closest behind with phase 3 results due later this year.

The EU positive opinion is for Tecentriq in combination with Celgene’s chemotherapy drug Abraxane (nab-paclitaxel) and is based on the results of the IMpassion130 trial, which showed adding Tecentriq to Abraxane reduced the risk of progression or death by 38% compared with Abraxane alone in this patient population.

Tecentriq is already approved to treat bladder cancer and non-small cell lung cancer (NSCLC), and the new indication is expected to help accelerate growth for the product, which made around $766 million in sales last year.

Roche has suggested in the past that breast cancer could eventually add another $500 million to $1 billion in revenues for the drug as it chases after Keytruda and Opdivo, which are predicted to top $9 billion and $7 billion in sales respectively this year.

To try to maintain its lead in TNBC the company has no fewer than seven phase 3 trials ongoing, including studies in patients with early and advanced stages of the disease.