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Roche adds kidney cancer to anti-PD-L1 programme

Inhibitor already indicated for lung, bladder and breast cancer

Roche Basel Switzerland 

Roche will shortly start phase III trials of its PD-L1 inhibitor in renal cell carcinoma (RCC), its fourth indication after lung, bladder and breast cancer, according to the company.

MPDL3280A is currently in six pivotal trials in non-small cell lung cancer, bladder carcinoma and triple-negative breast cancer, and will soon start testing it alongside Roche's angiogenesis inhibitor Avastin (bevacizumab) as a first-line therapy for RCC. 

There is a pressing need for new therapies for RCC, as even new treatment such as Pfizer's Sutent (sunitinib) and GlaxoSmithKline's Votrient (pazopanib) - while providing short-term benefit - eventually lose their efficacy and the cancer progresses.

"We believe we have one of the broadest and most powerful cancer immunotherapy programmes in the industry," said Daniel O'Day, Roche's chief operating officer, on the first-quarter results call.

"We now have seven new molecular entities in clinical testing across the portfolio from phase I to phase III," he added, suggesting MPDL3280A could be filed for approval next year or possibly sooner. 

Five of the seven ongoing studies are in NSCLC, which is considered a particularly attractive target for drugs targeting PD-1 or PD-L1. Bristol-Myers Squibb's Opdivo (nivolumab) is already approved for NSCLC in the US while Merck & Co's Keytruda (pembrolizumab) has just been filed for this indication with the FDA.

The FIR study is looking at MPDL3280A in patients with NSCLC who are screened for expression of the PD-L1 biomarker and therefore are expected to respond best to the drug, with data due to be presented at the American Society of Clinical Oncology (ASCO) meeting next month. 

A larger study in the same PD-L1-positive patient group - called BIRCH - is due to present data in the third quarter.

Meanwhile, interim data from the POPLAR study comparing Roche's drug to docetaxel as second- and third-line therapy for NSCLC will also be presented at ASCO, while the OAK study looking at overall survival in MPDL3280A and docetaxel-treated patients will generate results in 2016. 

Roche has also started five phase III trials of MPDL3280A as a first-line therapy for NSCLC, either in combination with chemotherapy or compared to chemotherapy in PD-L1-positive patients, and these due to complete in 2017 and 2018, according to O'Day.

Cancer portfolio drives revenue increase

News of the expanded trials programme for MPDL3280A came as Roche reported a solid financial start to the year, with sales up 5% at constant exchange rates to reach 11.83bn Swiss francs ($12.19bn), ahead of analyst expectations.

Sales of the company's HER2-targeting drugs - Herceptin (trastuzumab) and follow-up therapies Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine) - grew 23% thanks to increased use of Herceptin and Perjeta in combination, said Roche. The growth of Perjeta - up 82% to 322m francs in the quarter - is particularly encouraging for the company as it is facing patent expirations on Herceptin in Europe later this year and in 2019 in the US.

Sales of Roche's biggest-selling drug MabThera/Rituxan (rituximab) for haematological cancers and arthritis climbed 5% to 1.74bn francs while cancer therapy Avastin brought in 1.62bn francs, up 6%. 

Roche does not provide earnings for the first quarter.

Article by
Phil Taylor

23rd April 2015

From: Research



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