Germany’s Bayer AG and US group Onyx Pharmaceuticals have initiated a Phase III trial to assess the effectiveness of their kidney cancer drug Nexavar in patients with non-small cell lung cancer.
Around 900 patients at more than 130 sites in North America, South America, Europe and the Asia Pacific region are expected to take part in the trial, which will compare the efficacy of Nexavar (sorafenib) when administered with two chemotherapeutic agents - carboplatin and paclitaxel - versus carboplatin and paclitaxel alone.
“Despite recent therapeutic advances, non-small cell lung cancer remains a devastating disease,” remarked Susan Kelley, Vice President of Oncology at Bayer Pharmaceuticals. “In early clinical studies, we observed preliminary activity in a small number of NSCLC patients who received Nexavar administered in this drug combination,” she added.
Last December, Nexavar became the first new drug in more than a decade to treat adults with advanced renal cell carcinoma. It appears to be much less toxic than current treatments for this type of cancer, such as interleukin-2 or interferon-alpha, and has the additional benefit of being dosed orally rather than by injection. All this adds up to a drug with real blockbuster potential, according to Bayer, which is predicting sales of 1 billion euros ($1.2 billion) for the product.
Annual deaths in the US from lung cancer are currently estimated at 160,000, according to Bayer, so a green light for this new use could lift the product’s potential sales to a new level.
And Onyx, which is co-promoting Nexavar in the USA, will likely be crossing its fingers for a quick approval of this new use. The group saw its fourth-quarter 2005 loss jump $38.4 million, or $1.00 a share, for the period, compared with the year-earlier loss of $14.2 million, or $0.40, on burgeoning expenses and the absence of any revenues.