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Opdivo gets EU lung cancer nod as kidney cancer trial is halted

Bristol-MyersSquibb's checkpoint inhibitor gains European license for lung cancer

Bristol-Myers Squibb (BMS)Bristol-Myers Squibb's checkpoint inhibitor Opdivo has been cleared in the EU for non-small cell lung cancer (NSCLC) and seems to be closing in on a new indication in kidney cancer.

The European Commission cleared the PD-1 inhibitor for locally advanced or metastatic squamous (SQ) NSCLC after prior chemotherapy, consolidating BMS' lead over arch-rival Merck & Co - whose Keytruda (pembrolizumab) is not yet approved in the EU or indeed for lung cancer in any market.

BMS said the approval of Opdivo (nivolumab) "marks the first major treatment advance in SQ NSCLC in more than a decade in the EU" and looks likely to replace the current standard of care. The drug was approved for melanoma in the EU last month.

The green light came on the back of the CheckMate -017 and -063 studies, which compared Opdivo to standard therapy with docetaxel and revealed BMS' drug provided a superior clinical benefit, including a 41% reduction in the risk of death at one year and fewer side effects.

In Europe, the incidence of lung cancer - as well as mortality from the disease - is on the rise and it currently accounts for one in five cancer-related deaths. SQ NSCLC is one of the most common forms, accounting for 25-30% of all cases, according to BMS.

Opdivo was approved as a second-line treatment for SQ NSCLC by the US FDA in March and is also used to treat melanoma in direct competition with Keytruda.  

The PD-1 inhibitors as a whole are expected to bring in sales of $35bn or more at peak thanks to their unprecedented efficacy across multiple tumour types, although opinions differ over which drug - if any - will eventually come to dominate the market.

Clear benefit in kidney cancer

Opdivo seems to be on course to add renal cell carcinoma (RCC) to the list of tumour types in its portfolio, after BMS decided to terminate a trial comparing the drug to Novartis' Afinitor (everolimus) after a clear survival advantage was seen in an interim analysis. 

The company claims this is the first time that any of the new immuno-oncology therapeutics has been shown to improve survival in previously-treated patients with this form of kidney cancer, who have limited treatment options.

RCC is the most common type of kidney cancer and kills around 100,000 people every year, affecting men more than women. Only 12% of patients treated with currently-available therapies survive beyond five years.

Keytruda is also being tested in early-stage clinical trials for RCC - including as a first-line therapy - as is Roche's rival checkpoint inhibitor candidate atezolizumab (MPDL3280A) which is in phase III trials.

Article by
Phil Taylor

21st July 2015

From: Sales

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