Afinitor (everolimus), an mTOR (mammalian target of rapamycin) inhibitor, brought in $1.58bn last year. Novartis told investors yesterday this revenue will take a hit from Bristol-Myers Squibb’s Opdivo and from Californian biotech Exelixis’s cabozantinib.
But David Epstein, Head of Pharma, defended Afinitor’s future, saying the renal cell carcinoma (RCC) indication represents only 22% of the drug’s business. Breast cancer accounts for about half of Afinitor’s present sales.
The biologic could be pushed in still more indications, Epstein added, referring to a recent successful trial of Afinitor on neuroendocrine tumours. The company plans regulatory filings for this indication later this year.
He estimated the 25,000 to 30,000 metastatic neuroendocrine cancer patients “in the top seven markets” could effect Afinitor sales of between $250m and $350m for this one indication.
Yet he admitted that despite neuroendocrine revenue, the company expects Afinitor growth to slow “and that’s built into our model already.”
The competition
BMS announced on Monday a Phase III study comparing its biologic Opdivo (nivolumab) against Novartis’s Afinitor stopped early because of favourable results in patients with advanced or metastatic renal cell carcinoma (RCC).
BMS’s PD-1 immune checkpoint inhibitor is already approved in Japan and the US for metastatic squamous non-small cell lung cancer (NSCLC), and in the US for unresectable or metastatic melanoma and disease progression in combination with ipilimumab. The company has a programme of 50 Opdivo trials, testing it alone and in combination with other drugs.
San Francisco firm Exelixis also announced on Monday its Phase III trial of cabozantinib reduced the risk of disease progression or death from Metastatic Renal Cell Carcinoma by 42% compared to Afinitor. The company will file for authorisation in the US and EU early next year, it said.
The trial enrolled patients with RCC following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI). Cabozantinib has US FDA Fast Track designation.
Study lead Toni Choueiri said the difference in survival between Afinitor and cabozantinib was an improvement of “magnitude.”
Both studies are due for publication shortly. Afinitor’s main on-the-market competitor is Pfizer’s Ibrance.
Q2 results
Elsewhere during the earnings call yesterday, Novartis reported net sales for the quarter fell five per cent year-on-year to $12.7bn. Core earnings were down 8% to $3.1bn.
Execs partly attributed this to a “disappointing” quarter for Alcon, Novartis’s eyecare unit. Competition against its intraocular lens and slow growth in emerging markets contributed to weak sales, said Alcon head Jeff George.