July 5, 2017
By Mark Terry, BioSpace.com Breaking News Staff
PRINCETON, N.J. – Bristol-Myers Squibb announced promising interim data from its Phase III clinical trial of Opdivo 3 mg/kg compared to 10 mg/kg Yervoy in melanoma.
In patients with stage IIIb/c or stage IV melanoma who are at high risk of recurrence after complete surgical resection, Opdivo met its primary endpoint at the planned interim analysis. The endpoint was superior recurrence-free survival (RFS).
“These topline results support the potential promise of Opdivo as a treatment option for patients with high-risk surgically resected melanoma,” Vicki Goodman, BMS’ development lead for Melanoma and Genitourinary Cancer, said in a statement. “There remains an unmet need for additional options as the majority of stage III and resected stage IV high-risk melanoma patients experience disease recurrence after surgery. We are committed to researching therapies that may better meet the needs of this patient population and look forward to sharing these data with health authorities soon.”
The trial is CheckMate-238, which involves 906 patients receiving either Opdivo or Yervoy. The company’s statement did not release any data, but plans to present it at a future medical conference.
John Carroll, writing for Endpoints News, says, “Opdivo’s rocky road at Bristol has led to endless speculation that the company could find itself on the auction block before it gets a chance to reorganize in the clinic and come back in its head-to-head showdown with Merck ’s Keytruda. But it is also racking up billions in annual sales of Opdivo, with a slate of new trials underway.”
Seamus Fernandez, an analyst with Leerink, wrote in a note to investors, “This comes as a surprise, as top-line data were not expected until the final readout in 2H:18. While there were no details in the press release regarding the magnitude of benefit for Opdivo, we would expect it to become the standard of care in high-risk patients following surgical resection given its superior safety and tolerability profile relative to Yervoy. We estimate the adjuvant melanoma market will expand PD1 sales by approximately $3 billion globally. Although this likely will cannibalize sales of Yervoy in the setting (we estimate current adjuvant Yervoy sales at $300 to $400 million), the expansion of the market should add approximately $1 billion to Bristol-Myers’ net immune-oncology (IO) sales despite assumed competition from Merck (MRK)’s Keytruda (pembrolizumab; anti-PD-1).”
Currently, immuno-oncology therapy and in particular, combination therapies, appear to be dramatically expanding patient care for cancer patients. However, it also appears that the advantages for new combos is likely to be incremental in the future. And like in almost all areas of healthcare, drug pricing will become a factor.
Jeffrey Weber, a physician at NYU Langone, said in a panel discussion in spring 2016, “I think we’re going to see triple combinations. On the one hand, it’s scientifically fascinating, extremely complex with paradoxically a bar that’s now so high, it’s going to be very difficult to get combinations approved. You’re going to need to see major incremental advantages, which I think you probably will see with some of the drugs my colleagues have mentioned. But they’re also going to be very expensive, so pharmacoeconomics is also going to play a huge role in what we do. Right now, I would estimate that the cost of ipilimumab (Yervoy) plus nivolumab (Opdivo) therapy for a year is about $250,000. So, I would ask where does this all end?”
